Depression, Psychological Distress
Conditions
Brief summary
The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation \[HMP without meditation practice\]), and a waitlist control in a sample of United States adults with elevated depression symptoms.
Detailed description
Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of meditation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.
Interventions
DEVICEHealthy Minds Program
HMP is a 4-week mobile health (mHealth) meditation training program.
Sponsors
Hope for Depression Research Foundation
National Center for Complementary and Integrative Health (NCCIH)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
The groups will be randomized to one of three groups in a 2:2:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Elevated PHQ-8 or PHQ-9 ≥ 5 at screening * Proficient in English * Able to provide informed consent * Have access to a smartphone that can download apps from Google Play or the Apple App Store * For payment purposes, must be a US citizen or a permanent US resident
Exclusion criteria
* Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months * Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component \- Previous use of Healthy Minds Program app * Current suicidal intent and/or high self-injury risk (determined from the interview) * Self-reported history of psychosis * Self-reported history of mania * Current psychopathology that interferes with study participation as assessed by interview * Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion) * Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men * Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | Baseline, week 4, and 3 month follow up | The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use. |
| Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., my sleep was restful). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance. |
| Flourishing Measured by the Flourishing Index Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing. |
| Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus. |
| Connection Measured by NIH Toolbox Loneliness Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness. |
| Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience. |
| Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., I understand my life's meaning). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life. |
| Pain Intensity Measured by PROMIS Pain Intensity Score | Baseline, week 4 (of intervention period), and 3 month follow-up | The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity |
| Pain Interference Measured by PROMIS Pain Inference Scale Score | Baseline, week 4 (of intervention period), and 3 month follow-up | The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., how much did pain interfere with your enjoyment of life). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference. |
| Perseverative Thinking Questionnaire | Baseline, week 4, and 3 month follow up | The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., My thoughts repeat themselves). It is scored on a 5-point Likert scale where 0 = never to 4 = almost always. Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking. |
| Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience. |
| Climate Change Anxiety Scale | Baseline, week 4, and 3 month follow up | The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., I have nightmares about climate change). It is scored on a 5-point Likert scale where 1 = never to 5 = almost always. Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety. |
| Wellbeing Growth Mindset | Baseline, week 4, and 3 month follow up | The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., Your well-being is something about you that you can't change very much.). It is scored on a 6-point Likert scale where 1 = strongly disagree to 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset. |
| Healthy Minds Index (HM Index) - Awareness | Baseline, week 4, and 3 month follow up | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness. |
| Healthy Minds Index (HM Index) - Connection | Baseline, week 4, and 3 month follow up | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection. |
| Healthy Minds Index (HM Index) - Insight | Baseline, week 4, and 3 month follow up | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight. |
| Healthy Minds Index (HM Index) - Purpose | Baseline, week 4, and 3 month follow up | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose. |
| Life Orientation Test - Revised | Baseline, week 4, and 3 month follow up | The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., In uncertain times, I usually expect the best). It is scored on a 5-point Likert scale where 0 = strongly disagree to 4 = strongly agree. Total scores range from 0 to 24 where higher scores indicate greater optimism. |
| Perceived Stress Scale | Baseline, week 4, and 3 month follow up | The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., In the last month, how often have you felt nervous and 'stressed'?). It is scored on a 5-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 40 where higher scores indicate greater perceived stress. |
| Satisfaction With Life Scale | Baseline, week 4, and 3 month follow up | The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., In most ways my life is close to ideal). It is scored on a 7-point Likert scale where 1 = strongly disagree to 7 = strongly agree. Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life. |
| Subjective Happiness Scale | Baseline, week 4, and 3 month follow up | The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., In general, I consider myself \[not a very happy person, a very happy person\]). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness. |
| Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | Baseline and 3 month follow-up | Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from \ 200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1). |
| Microbiome Alpha Diversity: Species Richness | Baseline and 3 month follow-up | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species. |
| Microbiome Alpha Diversity: Shannon Diversity Index (H') | Baseline and 3 month follow-up | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Shannon Diversity Index quantifies both the richness and the evenness of a community. It takes into account the number of taxa (richness) and their relative abundances (evenness). A higher Shannon index value indicates greater diversity, with both a high number of taxa and more even distribution of abundances among them. It is often used to assess the balance between species in a community. Typically ranges from 0-5 with higher numbers indicating increasing species diversity. |
| Microbiome Alpha Diversity: Inverse Simpson (1/D) | Baseline and 3 month follow-up | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson is the probability that any two microbes are the same species, ranging from 0-1. Inverse Simpson (1 / Simpson) considers both richness and evenness. It places greater weight on the more abundant taxa. A higher inverse Simpson index suggests a more even distribution of taxa, with fewer dominant species. The inverse Simpson index is sensitive to the presence of dominant species and may emphasize diversity loss when one or a few species dominate the community. |
| Microbiome Alpha Diversity: Pielou Evenness Index (J) | Baseline and 3 month follow-up | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Pielou Evenness Index measures how evenly the individuals are distributed across the taxa in a sample. It is calculated by dividing the Shannon diversity index by the maximum possible value of the Shannon index (which occurs when all taxa are equally abundant). The Pielou index ranges from 0 (no evenness, where one species dominates) to 1 (perfect evenness, where all species are equally abundant). |
| Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Baseline and 3 month follow-up | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson's Dominance Index measures the probability that two randomly selected individuals from a community belong to the same species (or taxon). It ranges from 0 to 1, where 0 indicates perfect diversity (no dominance of a single species) and values closer to 1 indicate that one or a few species dominate the community. A lower Simpson's dominance score suggests a more diverse community, while a higher score indicates a community dominated by a few taxa. |
| Facial Behavior: Cheek Raise Score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling). Data are reported in Action Unit 6 (AU6) of Facial Action Coding System (FACS). FACS is an anatomically-based system for describing facial movement, breaking facial expressions into individual muscle movements called Action Units (AUs). The scores indicate the intensity of cheek movement (0-100), higher movements indicate more intense movement. |
| Lure Discrimination Task (LDI) | Baseline, week 4 (of intervention period), and 3 month follow-up | Meditation training has the capacity to normalize the overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate to alterations in the hippocampal-dependent process of pattern separation. The investigators will use a pattern separation task to evaluate hippocampal function. The Lure Discrimination Task (LDI) is the difference between the probability of giving a Similar response to the lure items (similar to target items) minus the probability of giving a Similar response to the foils (unrelated to target items). Larger differences indicate increased discrimination. |
| Self-Referential Pronoun Use | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore indicators of self-referent, inflexible, & over-generalized thinking within natural language. Reported here is the I self-referential word frequency. |
| Negative Affect Word Use: Negative Sentiment | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate more intense negative sentiment. |
| Negative Affect Word Use: Positive Sentiment | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate greater positive sentiment. |
| Treatment Expectancies | 3-month follow-up | The Treatment Expectancies is a 6-item scale assessing how much participants believed the training program was helpful to them. Items assess how participants think (e.g., At this point, how logical does the program offered to you seem?) and feel (e.g., At this point, how much do you really feel that the program helped you to reduce your stress symptoms?). Items are scored on either a 9-point Likert scale (e.g., 1 = not at all logical to 9 = very logical) or on a percentage (At the end of the program, how much improvement in your symptoms do you really feel occurred?, 0% to 100%). Higher scores reflect higher treatment expectancies. |
| Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 1, Week 2, Week 3, Week 4, 3-month follow-up | The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. Increase in scores indicates increase is depression symptoms. |
| Digital Working Alliance Inventory | week 1, week 2, week 3, week 4, and 3-month follow-up | The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., The HMP app supports me to overcome challenges). It is scored on a 7-point Likert scale where 1 = strongly disagree to 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate greater working alliance. |
| Inclusion of Nature in Self | Baseline, week 4 (of intervention period), and 3 month follow-up | The Inclusion of Nature in Self is a single item measure assessing the degree to which someone views nature as a part of their sense of self. Participants indicate which of a series of overlapping circles most closely resembles nature and their self. More overlapping circles indicate greater inclusion of nature in self. |
| Mindfulness Adherence Questionnaire | week 1, week 2, week 3, week 4, and 3 month follow up | The Mindfulness Adherence Questionnaire informal practice items are 6-items assessing the application of mindfulness during daily life (e.g., In your daily life, how much of the time were you practicing being gentle and compassionate toward yourself?). It is scored on a 7-point Likert scale where 0 = never to 6 = always. Total scores range from 0 to 42 where higher scores indicate greater informal mindfulness practice. |
| Change in Pre- and Post-practice Positive Affect | Before and after HMP activities week 1, week 2, week 2, and week 4 | Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys. |
| Change in Pre- and Post-practice Negative Affect | Before and after HMP activities week 1, week 2, week 2, and week 4 | Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys. |
| Change in Post-practice Focus | Before and after HMP activities week 1, week 2, week 2, and week 4 | A single item assessing focus during HMP activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time. Data comes from multiple surveys. |
| Inflammatory Biomarkers: C-reactive Protein (CRP) | Baseline and 3 month follow-up | Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from \ 200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Minds Program (HMP) App Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. | 462 |
| Psychoeducation App Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. | 463 |
| Usual Care Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. | 232 |
| Total | 1,157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Healthy Minds Program (HMP) App | Psychoeducation App | Usual Care |
|---|---|---|---|---|
| Age, Continuous | 38.69 years STANDARD_DEVIATION 12.13 | 38.34 years STANDARD_DEVIATION 11.84 | 39.02 years STANDARD_DEVIATION 12.18 | 38.72 years STANDARD_DEVIATION 12.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 112 Participants | 48 Participants | 40 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1004 Participants | 400 Participants | 406 Participants | 198 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 41 Participants | 14 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 2 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 62 Participants | 26 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 36 Participants | 46 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 82 Participants | 45 Participants | 25 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants | 12 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) White | 874 Participants | 341 Participants | 357 Participants | 176 Participants |
| Region of Enrollment United States | 1157 participants | 462 participants | 463 participants | 232 participants |
| Sex/Gender, Customized Man | 245 Participants | 93 Participants | 103 Participants | 49 Participants |
| Sex/Gender, Customized Other | 12 Participants | 3 Participants | 7 Participants | 2 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 30 Participants | 11 Participants | 11 Participants | 8 Participants |
| Sex/Gender, Customized Woman | 870 Participants | 355 Participants | 342 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 462 | 0 / 463 | 0 / 232 |
| other Total, other adverse events | 78 / 462 | 64 / 463 | 44 / 232 |
| serious Total, serious adverse events | 0 / 462 | 0 / 463 | 0 / 232 |
Outcome results
Primary
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | baseline | 10.06 score on a scale | Standard Deviation 4.85 |
| Healthy Minds Program (HMP) App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 1 | 9.17 score on a scale | Standard Deviation 4.72 |
| Healthy Minds Program (HMP) App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 2 | 8.37 score on a scale | Standard Deviation 4.75 |
| Healthy Minds Program (HMP) App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 3 | 7.88 score on a scale | Standard Deviation 4.9 |
| Healthy Minds Program (HMP) App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 4 | 7.21 score on a scale | Standard Deviation 4.8 |
| Healthy Minds Program (HMP) App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | 3-month follow-up | 6.67 score on a scale | Standard Deviation 4.6 |
| Psychoeducation App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | 3-month follow-up | 6.93 score on a scale | Standard Deviation 4.92 |
| Psychoeducation App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | baseline | 9.85 score on a scale | Standard Deviation 4.68 |
| Psychoeducation App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 3 | 8.01 score on a scale | Standard Deviation 4.84 |
| Psychoeducation App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 4 | 7.39 score on a scale | Standard Deviation 4.8 |
| Psychoeducation App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 1 | 8.8 score on a scale | Standard Deviation 4.71 |
| Psychoeducation App | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 2 | 8.28 score on a scale | Standard Deviation 4.6 |
| Usual Care | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 1 | 9.45 score on a scale | Standard Deviation 5.11 |
| Usual Care | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 2 | 9.03 score on a scale | Standard Deviation 5.22 |
| Usual Care | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | 3-month follow-up | 8.46 score on a scale | Standard Deviation 5.09 |
| Usual Care | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 3 | 9.21 score on a scale | Standard Deviation 4.93 |
| Usual Care | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | baseline | 9.79 score on a scale | Standard Deviation 4.75 |
| Usual Care | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 4 | 8.86 score on a scale | Standard Deviation 5.11 |
Secondary
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | baseline | 8.94 score on a scale | Standard Deviation 4.95 |
| Healthy Minds Program (HMP) App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 1 | 8.58 score on a scale | Standard Deviation 4.88 |
| Healthy Minds Program (HMP) App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 2 | 7.66 score on a scale | Standard Deviation 4.66 |
| Healthy Minds Program (HMP) App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 3 | 7.21 score on a scale | Standard Deviation 4.6 |
| Healthy Minds Program (HMP) App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 4 | 6.39 score on a scale | Standard Deviation 4.55 |
| Healthy Minds Program (HMP) App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | 3-month follow-up | 6.1 score on a scale | Standard Deviation 4.63 |
| Psychoeducation App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | 3-month follow-up | 6.22 score on a scale | Standard Deviation 4.75 |
| Psychoeducation App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | baseline | 8.67 score on a scale | Standard Deviation 4.97 |
| Psychoeducation App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 3 | 7.15 score on a scale | Standard Deviation 4.71 |
| Psychoeducation App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 4 | 6.46 score on a scale | Standard Deviation 4.6 |
| Psychoeducation App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 1 | 8.13 score on a scale | Standard Deviation 4.97 |
| Psychoeducation App | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 2 | 7.46 score on a scale | Standard Deviation 4.88 |
| Usual Care | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 1 | 8.04 score on a scale | Standard Deviation 5.27 |
| Usual Care | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 2 | 7.68 score on a scale | Standard Deviation 5.04 |
| Usual Care | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | 3-month follow-up | 7.08 score on a scale | Standard Deviation 5.09 |
| Usual Care | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 3 | 7.59 score on a scale | Standard Deviation 5.16 |
| Usual Care | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | baseline | 8.37 score on a scale | Standard Deviation 4.97 |
| Usual Care | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | Week 4 | 7.28 score on a scale | Standard Deviation 5.19 |
Secondary
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | baseline | 24.11 score on a scale | Standard Deviation 6.13 |
| Healthy Minds Program (HMP) App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 1 | 23.61 score on a scale | Standard Deviation 6.88 |
| Healthy Minds Program (HMP) App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 2 | 24.55 score on a scale | Standard Deviation 7.1 |
| Healthy Minds Program (HMP) App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 3 | 25.68 score on a scale | Standard Deviation 7.28 |
| Healthy Minds Program (HMP) App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 4 | 25.89 score on a scale | Standard Deviation 6.74 |
| Healthy Minds Program (HMP) App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | 3-month follow-up | 26.09 score on a scale | Standard Deviation 6.78 |
| Psychoeducation App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | 3-month follow-up | 26.18 score on a scale | Standard Deviation 6.32 |
| Psychoeducation App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | baseline | 24.41 score on a scale | Standard Deviation 6.32 |
| Psychoeducation App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 3 | 25.95 score on a scale | Standard Deviation 7.4 |
| Psychoeducation App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 4 | 26.03 score on a scale | Standard Deviation 6.83 |
| Psychoeducation App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 1 | 24.26 score on a scale | Standard Deviation 6.91 |
| Psychoeducation App | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 2 | 25.02 score on a scale | Standard Deviation 7.02 |
| Usual Care | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 1 | 24.27 score on a scale | Standard Deviation 7.35 |
| Usual Care | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 2 | 24.63 score on a scale | Standard Deviation 7.29 |
| Usual Care | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | 3-month follow-up | 24.75 score on a scale | Standard Deviation 6.75 |
| Usual Care | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 3 | 24.74 score on a scale | Standard Deviation 7.65 |
| Usual Care | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | baseline | 23.95 score on a scale | Standard Deviation 6.57 |
| Usual Care | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | Week 4 | 24.68 score on a scale | Standard Deviation 6.92 |
Secondary
Climate Change Anxiety Scale
The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., I have nightmares about climate change). It is scored on a 5-point Likert scale where 1 = never to 5 = almost always. Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Climate Change Anxiety Scale | Week 4 | 20.79 score on a scale | Standard Deviation 6.95 |
| Healthy Minds Program (HMP) App | Climate Change Anxiety Scale | baseline | 21.17 score on a scale | Standard Deviation 7.02 |
| Healthy Minds Program (HMP) App | Climate Change Anxiety Scale | 3-month follow-up | 20.5 score on a scale | Standard Deviation 6.68 |
| Psychoeducation App | Climate Change Anxiety Scale | Week 4 | 20.67 score on a scale | Standard Deviation 7.51 |
| Psychoeducation App | Climate Change Anxiety Scale | baseline | 20.98 score on a scale | Standard Deviation 7.54 |
| Psychoeducation App | Climate Change Anxiety Scale | 3-month follow-up | 20.34 score on a scale | Standard Deviation 7.74 |
| Usual Care | Climate Change Anxiety Scale | baseline | 21.22 score on a scale | Standard Deviation 7.91 |
| Usual Care | Climate Change Anxiety Scale | 3-month follow-up | 20.18 score on a scale | Standard Deviation 8.33 |
| Usual Care | Climate Change Anxiety Scale | Week 4 | 21.01 score on a scale | Standard Deviation 8.18 |
Secondary
Connection Measured by NIH Toolbox Loneliness Score
The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Connection Measured by NIH Toolbox Loneliness Score | baseline | 15.1 score on a scale | Standard Deviation 4.85 |
| Healthy Minds Program (HMP) App | Connection Measured by NIH Toolbox Loneliness Score | Week 1 | 14.33 score on a scale | Standard Deviation 5.11 |
| Healthy Minds Program (HMP) App | Connection Measured by NIH Toolbox Loneliness Score | Week 2 | 13.52 score on a scale | Standard Deviation 5.14 |
| Healthy Minds Program (HMP) App | Connection Measured by NIH Toolbox Loneliness Score | Week 3 | 13.05 score on a scale | Standard Deviation 5.28 |
| Healthy Minds Program (HMP) App | Connection Measured by NIH Toolbox Loneliness Score | Week 4 | 12.54 score on a scale | Standard Deviation 5.3 |
| Healthy Minds Program (HMP) App | Connection Measured by NIH Toolbox Loneliness Score | 3-month follow-up | 12.31 score on a scale | Standard Deviation 5.11 |
| Psychoeducation App | Connection Measured by NIH Toolbox Loneliness Score | 3-month follow-up | 12.82 score on a scale | Standard Deviation 4.96 |
| Psychoeducation App | Connection Measured by NIH Toolbox Loneliness Score | baseline | 14.74 score on a scale | Standard Deviation 4.63 |
| Psychoeducation App | Connection Measured by NIH Toolbox Loneliness Score | Week 3 | 13.00 score on a scale | Standard Deviation 4.79 |
| Psychoeducation App | Connection Measured by NIH Toolbox Loneliness Score | Week 4 | 12.41 score on a scale | Standard Deviation 4.74 |
| Psychoeducation App | Connection Measured by NIH Toolbox Loneliness Score | Week 1 | 13.97 score on a scale | Standard Deviation 4.82 |
| Psychoeducation App | Connection Measured by NIH Toolbox Loneliness Score | Week 2 | 13.24 score on a scale | Standard Deviation 4.64 |
| Usual Care | Connection Measured by NIH Toolbox Loneliness Score | Week 1 | 14.57 score on a scale | Standard Deviation 4.81 |
| Usual Care | Connection Measured by NIH Toolbox Loneliness Score | Week 2 | 13.86 score on a scale | Standard Deviation 4.98 |
| Usual Care | Connection Measured by NIH Toolbox Loneliness Score | 3-month follow-up | 14.10 score on a scale | Standard Deviation 4.81 |
| Usual Care | Connection Measured by NIH Toolbox Loneliness Score | Week 3 | 14.21 score on a scale | Standard Deviation 4.85 |
| Usual Care | Connection Measured by NIH Toolbox Loneliness Score | baseline | 15.13 score on a scale | Standard Deviation 4.66 |
| Usual Care | Connection Measured by NIH Toolbox Loneliness Score | Week 4 | 14.16 score on a scale | Standard Deviation 4.73 |
Secondary
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | baseline | 33.12 score on a scale | Standard Deviation 6.65 |
| Healthy Minds Program (HMP) App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 1 | 34.15 score on a scale | Standard Deviation 6.31 |
| Healthy Minds Program (HMP) App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 2 | 36.49 score on a scale | Standard Deviation 6.14 |
| Healthy Minds Program (HMP) App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 3 | 37.46 score on a scale | Standard Deviation 6.46 |
| Healthy Minds Program (HMP) App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 4 | 39.05 score on a scale | Standard Deviation 6.98 |
| Healthy Minds Program (HMP) App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | 3-month follow-up | 39.26 score on a scale | Standard Deviation 7.37 |
| Psychoeducation App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | 3-month follow-up | 38.37 score on a scale | Standard Deviation 7.42 |
| Psychoeducation App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | baseline | 33.22 score on a scale | Standard Deviation 6.95 |
| Psychoeducation App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 3 | 36.69 score on a scale | Standard Deviation 6.67 |
| Psychoeducation App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 4 | 37.94 score on a scale | Standard Deviation 7.17 |
| Psychoeducation App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 1 | 33.92 score on a scale | Standard Deviation 6.42 |
| Psychoeducation App | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 2 | 35.74 score on a scale | Standard Deviation 6.4 |
| Usual Care | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 1 | 33.99 score on a scale | Standard Deviation 6.94 |
| Usual Care | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 2 | 34.43 score on a scale | Standard Deviation 6.7 |
| Usual Care | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | 3-month follow-up | 35.55 score on a scale | Standard Deviation 7.04 |
| Usual Care | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 3 | 34.74 score on a scale | Standard Deviation 6.65 |
| Usual Care | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | baseline | 33.51 score on a scale | Standard Deviation 7.4 |
| Usual Care | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | Week 4 | 34.67 score on a scale | Standard Deviation 6.96 |
Secondary
Flourishing Measured by the Flourishing Index Score
The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time-points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Flourishing Measured by the Flourishing Index Score | baseline | 56.26 score on a scale | Standard Deviation 15.33 |
| Healthy Minds Program (HMP) App | Flourishing Measured by the Flourishing Index Score | Week 1 | 57.19 score on a scale | Standard Deviation 15.69 |
| Healthy Minds Program (HMP) App | Flourishing Measured by the Flourishing Index Score | Week 2 | 60.11 score on a scale | Standard Deviation 15.58 |
| Healthy Minds Program (HMP) App | Flourishing Measured by the Flourishing Index Score | Week 3 | 62.45 score on a scale | Standard Deviation 15.95 |
| Healthy Minds Program (HMP) App | Flourishing Measured by the Flourishing Index Score | Week 4 | 64.53 score on a scale | Standard Deviation 16.54 |
| Healthy Minds Program (HMP) App | Flourishing Measured by the Flourishing Index Score | 3-month follow-up | 66.00 score on a scale | Standard Deviation 16.58 |
| Psychoeducation App | Flourishing Measured by the Flourishing Index Score | 3-month follow-up | 64.62 score on a scale | Standard Deviation 16.76 |
| Psychoeducation App | Flourishing Measured by the Flourishing Index Score | baseline | 56.55 score on a scale | Standard Deviation 16.05 |
| Psychoeducation App | Flourishing Measured by the Flourishing Index Score | Week 3 | 60.87 score on a scale | Standard Deviation 15.77 |
| Psychoeducation App | Flourishing Measured by the Flourishing Index Score | Week 4 | 63.52 score on a scale | Standard Deviation 16.42 |
| Psychoeducation App | Flourishing Measured by the Flourishing Index Score | Week 1 | 57.52 score on a scale | Standard Deviation 15.83 |
| Psychoeducation App | Flourishing Measured by the Flourishing Index Score | Week 2 | 59.92 score on a scale | Standard Deviation 15.85 |
| Usual Care | Flourishing Measured by the Flourishing Index Score | Week 1 | 57.22 score on a scale | Standard Deviation 14.9 |
| Usual Care | Flourishing Measured by the Flourishing Index Score | Week 2 | 58.18 score on a scale | Standard Deviation 16.38 |
| Usual Care | Flourishing Measured by the Flourishing Index Score | 3-month follow-up | 60.99 score on a scale | Standard Deviation 15.43 |
| Usual Care | Flourishing Measured by the Flourishing Index Score | Week 3 | 58.30 score on a scale | Standard Deviation 15.8 |
| Usual Care | Flourishing Measured by the Flourishing Index Score | baseline | 56.63 score on a scale | Standard Deviation 15.22 |
| Usual Care | Flourishing Measured by the Flourishing Index Score | Week 4 | 59.29 score on a scale | Standard Deviation 16.43 |
Secondary
Healthy Minds Index (HM Index) - Awareness
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Awareness | Week 4 | 9.55 score on a scale | Standard Deviation 2.75 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Awareness | baseline | 9.13 score on a scale | Standard Deviation 2.72 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Awareness | 3-month follow-up | 9.72 score on a scale | Standard Deviation 2.78 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Awareness | Week 4 | 9.33 score on a scale | Standard Deviation 2.94 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Awareness | baseline | 9.11 score on a scale | Standard Deviation 2.8 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Awareness | 3-month follow-up | 9.5 score on a scale | Standard Deviation 2.88 |
| Usual Care | Healthy Minds Index (HM Index) - Awareness | baseline | 9.01 score on a scale | Standard Deviation 2.86 |
| Usual Care | Healthy Minds Index (HM Index) - Awareness | 3-month follow-up | 8.89 score on a scale | Standard Deviation 2.76 |
| Usual Care | Healthy Minds Index (HM Index) - Awareness | Week 4 | 8.72 score on a scale | Standard Deviation 2.91 |
Secondary
Healthy Minds Index (HM Index) - Connection
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Connection | Week 4 | 16.03 score on a scale | Standard Deviation 4.03 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Connection | baseline | 15.67 score on a scale | Standard Deviation 3.79 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Connection | 3-month follow-up | 15.88 score on a scale | Standard Deviation 4.02 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Connection | Week 4 | 16.16 score on a scale | Standard Deviation 3.86 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Connection | baseline | 15.65 score on a scale | Standard Deviation 3.49 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Connection | 3-month follow-up | 16.03 score on a scale | Standard Deviation 3.81 |
| Usual Care | Healthy Minds Index (HM Index) - Connection | baseline | 15.64 score on a scale | Standard Deviation 3.64 |
| Usual Care | Healthy Minds Index (HM Index) - Connection | 3-month follow-up | 15.08 score on a scale | Standard Deviation 3.94 |
| Usual Care | Healthy Minds Index (HM Index) - Connection | Week 4 | 15.16 score on a scale | Standard Deviation 3.72 |
Secondary
Healthy Minds Index (HM Index) - Insight
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Insight | Week 4 | 6.78 score on a scale | Standard Deviation 2.31 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Insight | baseline | 5.79 score on a scale | Standard Deviation 2.3 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Insight | 3-month follow-up | 6.86 score on a scale | Standard Deviation 2.34 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Insight | Week 4 | 6.71 score on a scale | Standard Deviation 2.29 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Insight | baseline | 5.76 score on a scale | Standard Deviation 2.44 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Insight | 3-month follow-up | 6.89 score on a scale | Standard Deviation 2.23 |
| Usual Care | Healthy Minds Index (HM Index) - Insight | baseline | 6.03 score on a scale | Standard Deviation 2.24 |
| Usual Care | Healthy Minds Index (HM Index) - Insight | 3-month follow-up | 6.08 score on a scale | Standard Deviation 2.26 |
| Usual Care | Healthy Minds Index (HM Index) - Insight | Week 4 | 6.07 score on a scale | Standard Deviation 2.16 |
Secondary
Healthy Minds Index (HM Index) - Purpose
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Purpose | Week 4 | 10.19 score on a scale | Standard Deviation 3.47 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Purpose | baseline | 9.07 score on a scale | Standard Deviation 3.57 |
| Healthy Minds Program (HMP) App | Healthy Minds Index (HM Index) - Purpose | 3-month follow-up | 10.48 score on a scale | Standard Deviation 3.34 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Purpose | Week 4 | 10.05 score on a scale | Standard Deviation 3.56 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Purpose | baseline | 8.8 score on a scale | Standard Deviation 3.71 |
| Psychoeducation App | Healthy Minds Index (HM Index) - Purpose | 3-month follow-up | 10.16 score on a scale | Standard Deviation 3.56 |
| Usual Care | Healthy Minds Index (HM Index) - Purpose | baseline | 9.22 score on a scale | Standard Deviation 3.61 |
| Usual Care | Healthy Minds Index (HM Index) - Purpose | 3-month follow-up | 9.43 score on a scale | Standard Deviation 3.95 |
| Usual Care | Healthy Minds Index (HM Index) - Purpose | Week 4 | 8.95 score on a scale | Standard Deviation 3.61 |
Secondary
Life Orientation Test - Revised
The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., In uncertain times, I usually expect the best). It is scored on a 5-point Likert scale where 0 = strongly disagree to 4 = strongly agree. Total scores range from 0 to 24 where higher scores indicate greater optimism.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Life Orientation Test - Revised | Week 4 | 13.42 score on a scale | Standard Deviation 5.02 |
| Healthy Minds Program (HMP) App | Life Orientation Test - Revised | baseline | 11.78 score on a scale | Standard Deviation 4.97 |
| Healthy Minds Program (HMP) App | Life Orientation Test - Revised | 3-month follow-up | 13.73 score on a scale | Standard Deviation 5.13 |
| Psychoeducation App | Life Orientation Test - Revised | Week 4 | 13.01 score on a scale | Standard Deviation 4.73 |
| Psychoeducation App | Life Orientation Test - Revised | baseline | 11.71 score on a scale | Standard Deviation 4.72 |
| Psychoeducation App | Life Orientation Test - Revised | 3-month follow-up | 13.17 score on a scale | Standard Deviation 4.83 |
| Usual Care | Life Orientation Test - Revised | baseline | 11.77 score on a scale | Standard Deviation 5.21 |
| Usual Care | Life Orientation Test - Revised | 3-month follow-up | 12.22 score on a scale | Standard Deviation 5.32 |
| Usual Care | Life Orientation Test - Revised | Week 4 | 12.23 score on a scale | Standard Deviation 4.98 |
Secondary
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., I understand my life's meaning). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | baseline | 43.44 T-score | Standard Deviation 9.89 |
| Healthy Minds Program (HMP) App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 1 | 42.89 T-score | Standard Deviation 9.64 |
| Healthy Minds Program (HMP) App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 2 | 44.07 T-score | Standard Deviation 9.89 |
| Healthy Minds Program (HMP) App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 3 | 44.98 T-score | Standard Deviation 10.25 |
| Healthy Minds Program (HMP) App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 4 | 46.86 T-score | Standard Deviation 11.07 |
| Healthy Minds Program (HMP) App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | 3-month follow-up | 47.64 T-score | Standard Deviation 10.93 |
| Psychoeducation App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | 3-month follow-up | 46.19 T-score | Standard Deviation 10.69 |
| Psychoeducation App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | baseline | 43.09 T-score | Standard Deviation 9.78 |
| Psychoeducation App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 3 | 44.27 T-score | Standard Deviation 10.47 |
| Psychoeducation App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 4 | 45.74 T-score | Standard Deviation 10.63 |
| Psychoeducation App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 1 | 42.59 T-score | Standard Deviation 9.74 |
| Psychoeducation App | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 2 | 43.66 T-score | Standard Deviation 9.96 |
| Usual Care | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 1 | 41.58 T-score | Standard Deviation 9.67 |
| Usual Care | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 2 | 41.71 T-score | Standard Deviation 11.03 |
| Usual Care | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | 3-month follow-up | 44.21 T-score | Standard Deviation 10.6 |
| Usual Care | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 3 | 41.96 T-score | Standard Deviation 10.61 |
| Usual Care | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | baseline | 43.33 T-score | Standard Deviation 9.76 |
| Usual Care | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | Week 4 | 42.88 T-score | Standard Deviation 10.47 |
Secondary
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | baseline | 24.62 score on a scale | Standard Deviation 7.05 |
| Healthy Minds Program (HMP) App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 1 | 26.24 score on a scale | Standard Deviation 7.45 |
| Healthy Minds Program (HMP) App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 2 | 27.98 score on a scale | Standard Deviation 7.46 |
| Healthy Minds Program (HMP) App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 3 | 29.53 score on a scale | Standard Deviation 7.5 |
| Healthy Minds Program (HMP) App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 4 | 28.93 score on a scale | Standard Deviation 6.86 |
| Healthy Minds Program (HMP) App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | 3-month follow-up | 28.89 score on a scale | Standard Deviation 6.77 |
| Psychoeducation App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | 3-month follow-up | 27.83 score on a scale | Standard Deviation 6.95 |
| Psychoeducation App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | baseline | 24.35 score on a scale | Standard Deviation 6.88 |
| Psychoeducation App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 3 | 28.57 score on a scale | Standard Deviation 7.68 |
| Psychoeducation App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 4 | 28.16 score on a scale | Standard Deviation 6.9 |
| Psychoeducation App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 1 | 26.32 score on a scale | Standard Deviation 7.47 |
| Psychoeducation App | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 2 | 27.46 score on a scale | Standard Deviation 7.55 |
| Usual Care | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 1 | 25.84 score on a scale | Standard Deviation 7.8 |
| Usual Care | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 2 | 26.88 score on a scale | Standard Deviation 7.67 |
| Usual Care | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | 3-month follow-up | 26.12 score on a scale | Standard Deviation 7.42 |
| Usual Care | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 3 | 26.99 score on a scale | Standard Deviation 7.97 |
| Usual Care | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | baseline | 23.92 score on a scale | Standard Deviation 6.89 |
| Usual Care | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | Week 4 | 26.35 score on a scale | Standard Deviation 7.62 |
Secondary
Pain Intensity Measured by PROMIS Pain Intensity Score
The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity
Time frame: Baseline, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Pain Intensity Measured by PROMIS Pain Intensity Score | Week 4 | 2.98 score on a scale | Standard Deviation 2.6 |
| Healthy Minds Program (HMP) App | Pain Intensity Measured by PROMIS Pain Intensity Score | baseline | 3.22 score on a scale | Standard Deviation 2.54 |
| Healthy Minds Program (HMP) App | Pain Intensity Measured by PROMIS Pain Intensity Score | 3-month follow-up | 3.11 score on a scale | Standard Deviation 2.63 |
| Psychoeducation App | Pain Intensity Measured by PROMIS Pain Intensity Score | Week 4 | 3.12 score on a scale | Standard Deviation 2.57 |
| Psychoeducation App | Pain Intensity Measured by PROMIS Pain Intensity Score | baseline | 3.33 score on a scale | Standard Deviation 2.53 |
| Psychoeducation App | Pain Intensity Measured by PROMIS Pain Intensity Score | 3-month follow-up | 3.07 score on a scale | Standard Deviation 2.59 |
| Usual Care | Pain Intensity Measured by PROMIS Pain Intensity Score | baseline | 3.42 score on a scale | Standard Deviation 2.59 |
| Usual Care | Pain Intensity Measured by PROMIS Pain Intensity Score | 3-month follow-up | 3.39 score on a scale | Standard Deviation 2.73 |
| Usual Care | Pain Intensity Measured by PROMIS Pain Intensity Score | Week 4 | 3.5 score on a scale | Standard Deviation 2.81 |
Secondary
Pain Interference Measured by PROMIS Pain Inference Scale Score
The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., how much did pain interfere with your enjoyment of life). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference.
Time frame: Baseline, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Pain Interference Measured by PROMIS Pain Inference Scale Score | Week 4 | 51.65 T-score | Standard Deviation 10.55 |
| Healthy Minds Program (HMP) App | Pain Interference Measured by PROMIS Pain Inference Scale Score | baseline | 52.94 T-score | Standard Deviation 10.27 |
| Healthy Minds Program (HMP) App | Pain Interference Measured by PROMIS Pain Inference Scale Score | 3-month follow-up | 52.21 T-score | Standard Deviation 10.65 |
| Psychoeducation App | Pain Interference Measured by PROMIS Pain Inference Scale Score | Week 4 | 51.66 T-score | Standard Deviation 9.81 |
| Psychoeducation App | Pain Interference Measured by PROMIS Pain Inference Scale Score | baseline | 53.6 T-score | Standard Deviation 10.17 |
| Psychoeducation App | Pain Interference Measured by PROMIS Pain Inference Scale Score | 3-month follow-up | 52.13 T-score | Standard Deviation 10.17 |
| Usual Care | Pain Interference Measured by PROMIS Pain Inference Scale Score | baseline | 53.57 T-score | Standard Deviation 10.51 |
| Usual Care | Pain Interference Measured by PROMIS Pain Inference Scale Score | 3-month follow-up | 52.96 T-score | Standard Deviation 11.06 |
| Usual Care | Pain Interference Measured by PROMIS Pain Inference Scale Score | Week 4 | 53.16 T-score | Standard Deviation 10.91 |
Secondary
Perceived Stress Scale
The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., In the last month, how often have you felt nervous and 'stressed'?). It is scored on a 5-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Perceived Stress Scale | Week 4 | 26.46 score on a scale | Standard Deviation 6.82 |
| Healthy Minds Program (HMP) App | Perceived Stress Scale | baseline | 29.7 score on a scale | Standard Deviation 6.77 |
| Healthy Minds Program (HMP) App | Perceived Stress Scale | 3-month follow-up | 25.70 score on a scale | Standard Deviation 7.37 |
| Psychoeducation App | Perceived Stress Scale | Week 4 | 26.90 score on a scale | Standard Deviation 6.54 |
| Psychoeducation App | Perceived Stress Scale | baseline | 29.51 score on a scale | Standard Deviation 6.29 |
| Psychoeducation App | Perceived Stress Scale | 3-month follow-up | 26.03 score on a scale | Standard Deviation 7.1 |
| Usual Care | Perceived Stress Scale | baseline | 29.72 score on a scale | Standard Deviation 6.64 |
| Usual Care | Perceived Stress Scale | 3-month follow-up | 28.45 score on a scale | Standard Deviation 7.11 |
| Usual Care | Perceived Stress Scale | Week 4 | 29.17 score on a scale | Standard Deviation 6.54 |
Secondary
Perseverative Thinking Questionnaire
The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., My thoughts repeat themselves). It is scored on a 5-point Likert scale where 0 = never to 4 = almost always. Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Perseverative Thinking Questionnaire | 4 week | 26.94 score on a scale | Standard Deviation 11.9 |
| Healthy Minds Program (HMP) App | Perseverative Thinking Questionnaire | baseline | 32.02 score on a scale | Standard Deviation 11.34 |
| Healthy Minds Program (HMP) App | Perseverative Thinking Questionnaire | 3-month follow-up | 25.39 score on a scale | Standard Deviation 12.4 |
| Psychoeducation App | Perseverative Thinking Questionnaire | 4 week | 27.08 score on a scale | Standard Deviation 11.59 |
| Psychoeducation App | Perseverative Thinking Questionnaire | baseline | 31.14 score on a scale | Standard Deviation 11.56 |
| Psychoeducation App | Perseverative Thinking Questionnaire | 3-month follow-up | 26.48 score on a scale | Standard Deviation 12.03 |
| Usual Care | Perseverative Thinking Questionnaire | baseline | 31.56 score on a scale | Standard Deviation 11.83 |
| Usual Care | Perseverative Thinking Questionnaire | 3-month follow-up | 29.28 score on a scale | Standard Deviation 12.55 |
| Usual Care | Perseverative Thinking Questionnaire | 4 week | 30.69 score on a scale | Standard Deviation 11.93 |
Secondary
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)
The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | Week 4 | 3.96 score on a scale | Standard Deviation 2.83 |
| Healthy Minds Program (HMP) App | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | baseline | 4.79 score on a scale | Standard Deviation 2.68 |
| Healthy Minds Program (HMP) App | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | 3-month follow-up | 3.81 score on a scale | Standard Deviation 2.75 |
| Psychoeducation App | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | Week 4 | 3.97 score on a scale | Standard Deviation 2.76 |
| Psychoeducation App | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | baseline | 4.45 score on a scale | Standard Deviation 2.74 |
| Psychoeducation App | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | 3-month follow-up | 3.63 score on a scale | Standard Deviation 2.61 |
| Usual Care | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | baseline | 4.42 score on a scale | Standard Deviation 2.87 |
| Usual Care | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | 3-month follow-up | 4.50 score on a scale | Standard Deviation 2.82 |
| Usual Care | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | Week 4 | 4.94 score on a scale | Standard Deviation 3.15 |
Secondary
Satisfaction With Life Scale
The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., In most ways my life is close to ideal). It is scored on a 7-point Likert scale where 1 = strongly disagree to 7 = strongly agree. Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Satisfaction With Life Scale | 3-month follow-up | 20.33 score on a scale | Standard Deviation 7.81 |
| Healthy Minds Program (HMP) App | Satisfaction With Life Scale | baseline | 17.25 score on a scale | Standard Deviation 7.3 |
| Healthy Minds Program (HMP) App | Satisfaction With Life Scale | Week 4 | 19.62 score on a scale | Standard Deviation 7.72 |
| Psychoeducation App | Satisfaction With Life Scale | Week 4 | 19.40 score on a scale | Standard Deviation 7.37 |
| Psychoeducation App | Satisfaction With Life Scale | 3-month follow-up | 19.94 score on a scale | Standard Deviation 7.61 |
| Psychoeducation App | Satisfaction With Life Scale | baseline | 17.27 score on a scale | Standard Deviation 7.24 |
| Usual Care | Satisfaction With Life Scale | baseline | 17.08 score on a scale | Standard Deviation 7.22 |
| Usual Care | Satisfaction With Life Scale | 3-month follow-up | 18.04 score on a scale | Standard Deviation 7.42 |
| Usual Care | Satisfaction With Life Scale | Week 4 | 17.51 score on a scale | Standard Deviation 7.47 |
Secondary
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., my sleep was restful). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | baseline | 57.73 T-score | Standard Deviation 8.03 |
| Healthy Minds Program (HMP) App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 1 | 56.26 T-score | Standard Deviation 8.35 |
| Healthy Minds Program (HMP) App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 2 | 55.78 T-score | Standard Deviation 8.93 |
| Healthy Minds Program (HMP) App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 3 | 55.14 T-score | Standard Deviation 9.24 |
| Healthy Minds Program (HMP) App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 4 | 54.23 T-score | Standard Deviation 9.06 |
| Healthy Minds Program (HMP) App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 3-month follow-up | 53.61 T-score | Standard Deviation 9.1 |
| Psychoeducation App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 3-month follow-up | 53.51 T-score | Standard Deviation 9.29 |
| Psychoeducation App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | baseline | 56.94 T-score | Standard Deviation 8.16 |
| Psychoeducation App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 3 | 54.8 T-score | Standard Deviation 8.96 |
| Psychoeducation App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 4 | 54.17 T-score | Standard Deviation 8.76 |
| Psychoeducation App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 1 | 55.91 T-score | Standard Deviation 8.31 |
| Psychoeducation App | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 2 | 55.48 T-score | Standard Deviation 8.04 |
| Usual Care | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 1 | 57.12 T-score | Standard Deviation 8.67 |
| Usual Care | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 2 | 55.65 T-score | Standard Deviation 9.19 |
| Usual Care | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 3-month follow-up | 55.76 T-score | Standard Deviation 9.31 |
| Usual Care | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 3 | 56.53 T-score | Standard Deviation 8.95 |
| Usual Care | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | baseline | 56.9 T-score | Standard Deviation 8.41 |
| Usual Care | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Week 4 | 55.81 T-score | Standard Deviation 9.23 |
Secondary
Subjective Happiness Scale
The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., In general, I consider myself \[not a very happy person, a very happy person\]). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Subjective Happiness Scale | Week 4 | 17.91 score on a scale | Standard Deviation 5.14 |
| Healthy Minds Program (HMP) App | Subjective Happiness Scale | baseline | 16.45 score on a scale | Standard Deviation 4.96 |
| Healthy Minds Program (HMP) App | Subjective Happiness Scale | 3-month follow-up | 18.20 score on a scale | Standard Deviation 5.31 |
| Psychoeducation App | Subjective Happiness Scale | Week 4 | 17.36 score on a scale | Standard Deviation 5.24 |
| Psychoeducation App | Subjective Happiness Scale | baseline | 16.53 score on a scale | Standard Deviation 5.25 |
| Psychoeducation App | Subjective Happiness Scale | 3-month follow-up | 17.77 score on a scale | Standard Deviation 5.54 |
| Usual Care | Subjective Happiness Scale | baseline | 16.29 score on a scale | Standard Deviation 4.93 |
| Usual Care | Subjective Happiness Scale | 3-month follow-up | 16.62 score on a scale | Standard Deviation 4.93 |
| Usual Care | Subjective Happiness Scale | Week 4 | 16.35 score on a scale | Standard Deviation 4.94 |
Secondary
Wellbeing Growth Mindset
The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., Your well-being is something about you that you can't change very much.). It is scored on a 6-point Likert scale where 1 = strongly disagree to 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset.
Time frame: Baseline, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Wellbeing Growth Mindset | Week 4 | 14.61 score on a scale | Standard Deviation 2.9 |
| Healthy Minds Program (HMP) App | Wellbeing Growth Mindset | baseline | 14.27 score on a scale | Standard Deviation 2.83 |
| Healthy Minds Program (HMP) App | Wellbeing Growth Mindset | 3-month follow-up | 14.31 score on a scale | Standard Deviation 2.93 |
| Psychoeducation App | Wellbeing Growth Mindset | Week 4 | 14.46 score on a scale | Standard Deviation 2.7 |
| Psychoeducation App | Wellbeing Growth Mindset | baseline | 14.07 score on a scale | Standard Deviation 2.89 |
| Psychoeducation App | Wellbeing Growth Mindset | 3-month follow-up | 14.04 score on a scale | Standard Deviation 3.1 |
| Usual Care | Wellbeing Growth Mindset | baseline | 13.88 score on a scale | Standard Deviation 3.17 |
| Usual Care | Wellbeing Growth Mindset | 3-month follow-up | 13.54 score on a scale | Standard Deviation 3.12 |
| Usual Care | Wellbeing Growth Mindset | Week 4 | 13.50 score on a scale | Standard Deviation 3.23 |
Other Pre-specified
Change in Post-practice Focus
A single item assessing focus during HMP activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time. Data comes from multiple surveys.
Time frame: Before and after HMP activities week 1, week 2, week 2, and week 4
Population: Data collected only from HMP arm per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Change in Post-practice Focus | Week 1 | 5.93 score on a scale | Standard Deviation 1.22 |
| Healthy Minds Program (HMP) App | Change in Post-practice Focus | Week 2 | 6.08 score on a scale | Standard Deviation 1.14 |
| Healthy Minds Program (HMP) App | Change in Post-practice Focus | Week 3 | 6.08 score on a scale | Standard Deviation 1.23 |
| Healthy Minds Program (HMP) App | Change in Post-practice Focus | Week 4 | 6.21 score on a scale | Standard Deviation 1.06 |
Other Pre-specified
Change in Pre- and Post-practice Negative Affect
Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys.
Time frame: Before and after HMP activities week 1, week 2, week 2, and week 4
Population: The usual care arm was not surveyed for this measure per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 1 | -0.51 score on a scale | Standard Deviation 0.92 |
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 2 | -0.38 score on a scale | Standard Deviation 0.88 |
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 3 | -0.30 score on a scale | Standard Deviation 0.75 |
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 4 | -0.33 score on a scale | Standard Deviation 0.82 |
| Psychoeducation App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 4 | -0.21 score on a scale | Standard Deviation 0.8 |
| Psychoeducation App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 1 | -0.42 score on a scale | Standard Deviation 0.95 |
| Psychoeducation App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 3 | -0.29 score on a scale | Standard Deviation 0.79 |
| Psychoeducation App | Change in Pre- and Post-practice Negative Affect | Change from Before and After Intervention Week 2 | -0.29 score on a scale | Standard Deviation 0.85 |
Other Pre-specified
Change in Pre- and Post-practice Positive Affect
Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys.
Time frame: Before and after HMP activities week 1, week 2, week 2, and week 4
Population: The usual care arm was not surveyed for this measure per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 1 | 0.54 score on a scale | Standard Deviation 0.99 |
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 2 | 0.44 score on a scale | Standard Deviation 0.9 |
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 3 | 0.38 score on a scale | Standard Deviation 0.8 |
| Healthy Minds Program (HMP) App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 4 | 0.36 score on a scale | Standard Deviation 0.85 |
| Psychoeducation App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 4 | 0.24 score on a scale | Standard Deviation 0.78 |
| Psychoeducation App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 1 | 0.35 score on a scale | Standard Deviation 0.9 |
| Psychoeducation App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 3 | 0.28 score on a scale | Standard Deviation 0.76 |
| Psychoeducation App | Change in Pre- and Post-practice Positive Affect | Change from Before and After Intervention Week 2 | 0.33 score on a scale | Standard Deviation 0.83 |
Other Pre-specified
Digital Working Alliance Inventory
The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., The HMP app supports me to overcome challenges). It is scored on a 7-point Likert scale where 1 = strongly disagree to 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate greater working alliance.
Time frame: week 1, week 2, week 3, week 4, and 3-month follow-up
Population: Some participants did not provide data at all time points. The usual care arm was not surveyed for this measure per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Digital Working Alliance Inventory | Week 2 | 32.67 score on a scale | Standard Deviation 5.84 |
| Healthy Minds Program (HMP) App | Digital Working Alliance Inventory | Week 4 | 33.72 score on a scale | Standard Deviation 6.75 |
| Healthy Minds Program (HMP) App | Digital Working Alliance Inventory | Week 3 | 33.37 score on a scale | Standard Deviation 6.55 |
| Healthy Minds Program (HMP) App | Digital Working Alliance Inventory | 3-month follow-up | 31.94 score on a scale | Standard Deviation 7.51 |
| Healthy Minds Program (HMP) App | Digital Working Alliance Inventory | Week 1 | 32.04 score on a scale | Standard Deviation 6.35 |
| Psychoeducation App | Digital Working Alliance Inventory | 3-month follow-up | 30.89 score on a scale | Standard Deviation 7.53 |
| Psychoeducation App | Digital Working Alliance Inventory | Week 1 | 30.65 score on a scale | Standard Deviation 6.29 |
| Psychoeducation App | Digital Working Alliance Inventory | Week 2 | 30.89 score on a scale | Standard Deviation 6.89 |
| Psychoeducation App | Digital Working Alliance Inventory | Week 3 | 31.79 score on a scale | Standard Deviation 6.9 |
| Psychoeducation App | Digital Working Alliance Inventory | Week 4 | 32.25 score on a scale | Standard Deviation 7.27 |
Other Pre-specified
Facial Behavior: Cheek Raise Score
Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling). Data are reported in Action Unit 6 (AU6) of Facial Action Coding System (FACS). FACS is an anatomically-based system for describing facial movement, breaking facial expressions into individual muscle movements called Action Units (AUs). The scores indicate the intensity of cheek movement (0-100), higher movements indicate more intense movement.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Facial Behavior: Cheek Raise Score | Week 4 | 10.40 score on a scale | Standard Deviation 12.27 |
| Healthy Minds Program (HMP) App | Facial Behavior: Cheek Raise Score | Week 2 | 9.77 score on a scale | Standard Deviation 12.25 |
| Healthy Minds Program (HMP) App | Facial Behavior: Cheek Raise Score | 3-month follow-up | 11.57 score on a scale | Standard Deviation 13.99 |
| Healthy Minds Program (HMP) App | Facial Behavior: Cheek Raise Score | baseline | 11.92 score on a scale | Standard Deviation 15.4 |
| Healthy Minds Program (HMP) App | Facial Behavior: Cheek Raise Score | Week 3 | 10.15 score on a scale | Standard Deviation 12.35 |
| Healthy Minds Program (HMP) App | Facial Behavior: Cheek Raise Score | Week 1 | 9.91 score on a scale | Standard Deviation 12.61 |
| Psychoeducation App | Facial Behavior: Cheek Raise Score | Week 3 | 10.28 score on a scale | Standard Deviation 13.73 |
| Psychoeducation App | Facial Behavior: Cheek Raise Score | Week 4 | 11.16 score on a scale | Standard Deviation 14.54 |
| Psychoeducation App | Facial Behavior: Cheek Raise Score | 3-month follow-up | 10.55 score on a scale | Standard Deviation 14.88 |
| Psychoeducation App | Facial Behavior: Cheek Raise Score | Week 1 | 10.05 score on a scale | Standard Deviation 13.39 |
| Psychoeducation App | Facial Behavior: Cheek Raise Score | baseline | 12.43 score on a scale | Standard Deviation 15.97 |
| Psychoeducation App | Facial Behavior: Cheek Raise Score | Week 2 | 10.64 score on a scale | Standard Deviation 12.42 |
| Usual Care | Facial Behavior: Cheek Raise Score | 3-month follow-up | 8.60 score on a scale | Standard Deviation 12.84 |
| Usual Care | Facial Behavior: Cheek Raise Score | baseline | 10.06 score on a scale | Standard Deviation 12.86 |
| Usual Care | Facial Behavior: Cheek Raise Score | Week 1 | 8.55 score on a scale | Standard Deviation 11.23 |
| Usual Care | Facial Behavior: Cheek Raise Score | Week 2 | 7.43 score on a scale | Standard Deviation 10.6 |
| Usual Care | Facial Behavior: Cheek Raise Score | Week 3 | 8.29 score on a scale | Standard Deviation 12.43 |
| Usual Care | Facial Behavior: Cheek Raise Score | Week 4 | 8.58 score on a scale | Standard Deviation 10.12 |
Other Pre-specified
Inclusion of Nature in Self
The Inclusion of Nature in Self is a single item measure assessing the degree to which someone views nature as a part of their sense of self. Participants indicate which of a series of overlapping circles most closely resembles nature and their self. More overlapping circles indicate greater inclusion of nature in self.
Time frame: Baseline, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all-time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Inclusion of Nature in Self | Week 4 | 4.54 overlapping circles | Standard Deviation 1.65 |
| Healthy Minds Program (HMP) App | Inclusion of Nature in Self | baseline | 4.06 overlapping circles | Standard Deviation 1.7 |
| Healthy Minds Program (HMP) App | Inclusion of Nature in Self | 3-month follow-up | 4.41 overlapping circles | Standard Deviation 1.63 |
| Psychoeducation App | Inclusion of Nature in Self | Week 4 | 4.26 overlapping circles | Standard Deviation 1.74 |
| Psychoeducation App | Inclusion of Nature in Self | baseline | 4.04 overlapping circles | Standard Deviation 1.73 |
| Psychoeducation App | Inclusion of Nature in Self | 3-month follow-up | 4.18 overlapping circles | Standard Deviation 1.73 |
| Usual Care | Inclusion of Nature in Self | baseline | 3.89 overlapping circles | Standard Deviation 1.72 |
| Usual Care | Inclusion of Nature in Self | 3-month follow-up | 3.84 overlapping circles | Standard Deviation 1.71 |
| Usual Care | Inclusion of Nature in Self | Week 4 | 4.02 overlapping circles | Standard Deviation 1.71 |
Other Pre-specified
Inflammatory Biomarkers: C-reactive Protein (CRP)
Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from \ 200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).
Time frame: Baseline and 3 month follow-up
Population: Data not provided or evaluable from all participants at all time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: C-reactive Protein (CRP) | baseline | 2.34 mg/L | Standard Deviation 3.99 |
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: C-reactive Protein (CRP) | 3-month follow-up | 2.56 mg/L | Standard Deviation 4.17 |
| Psychoeducation App | Inflammatory Biomarkers: C-reactive Protein (CRP) | baseline | 2.68 mg/L | Standard Deviation 4.16 |
| Psychoeducation App | Inflammatory Biomarkers: C-reactive Protein (CRP) | 3-month follow-up | 2.89 mg/L | Standard Deviation 4.55 |
| Usual Care | Inflammatory Biomarkers: C-reactive Protein (CRP) | baseline | 2.67 mg/L | Standard Deviation 2.43 |
| Usual Care | Inflammatory Biomarkers: C-reactive Protein (CRP) | 3-month follow-up | 2.60 mg/L | Standard Deviation 4.05 |
Other Pre-specified
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from \ 200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).
Time frame: Baseline and 3 month follow-up
Population: Data not provided or evaluable from all participants at all time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | TNF-Alpha at baseline | 2.12 pg/mL | Standard Deviation 7.08 |
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | TNF-Alpha at 3-month follow-up | 1.83 pg/mL | Standard Deviation 3.71 |
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-6 at baseline | 0.81 pg/mL | Standard Deviation 6.94 |
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-6 at 3-month follow-up | 0.81 pg/mL | Standard Deviation 5.18 |
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-10 at baseline | 0.12 pg/mL | Standard Deviation 0.19 |
| Healthy Minds Program (HMP) App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-10 at 3-month follow-up | 0.13 pg/mL | Standard Deviation 0.2 |
| Psychoeducation App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-10 at 3-month follow-up | 0.14 pg/mL | Standard Deviation 0.25 |
| Psychoeducation App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | TNF-Alpha at baseline | 1.69 pg/mL | Standard Deviation 0.85 |
| Psychoeducation App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-6 at 3-month follow-up | 0.37 pg/mL | Standard Deviation 0.68 |
| Psychoeducation App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-10 at baseline | 0.13 pg/mL | Standard Deviation 0.23 |
| Psychoeducation App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | TNF-Alpha at 3-month follow-up | 1.62 pg/mL | Standard Deviation 0.83 |
| Psychoeducation App | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-6 at baseline | 0.33 pg/mL | Standard Deviation 0.36 |
| Usual Care | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | TNF-Alpha at 3-month follow-up | 2.02 pg/mL | Standard Deviation 3.11 |
| Usual Care | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-6 at baseline | 0.36 pg/mL | Standard Deviation 0.48 |
| Usual Care | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-10 at 3-month follow-up | 0.37 pg/mL | Standard Deviation 2.81 |
| Usual Care | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-6 at 3-month follow-up | 0.73 pg/mL | Standard Deviation 2.95 |
| Usual Care | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | TNF-Alpha at baseline | 1.75 pg/mL | Standard Deviation 0.79 |
| Usual Care | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | IL-10 at baseline | 0.36 pg/mL | Standard Deviation 2.76 |
Other Pre-specified
Lure Discrimination Task (LDI)
Meditation training has the capacity to normalize the overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate to alterations in the hippocampal-dependent process of pattern separation. The investigators will use a pattern separation task to evaluate hippocampal function. The Lure Discrimination Task (LDI) is the difference between the probability of giving a Similar response to the lure items (similar to target items) minus the probability of giving a Similar response to the foils (unrelated to target items). Larger differences indicate increased discrimination.
Time frame: Baseline, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Lure Discrimination Task (LDI) | Week 4 | 0.47 Lure Discrimination Index | Standard Deviation 0.21 |
| Healthy Minds Program (HMP) App | Lure Discrimination Task (LDI) | baseline | 0.44 Lure Discrimination Index | Standard Deviation 0.2 |
| Healthy Minds Program (HMP) App | Lure Discrimination Task (LDI) | 3-month follow-up | 0.48 Lure Discrimination Index | Standard Deviation 0.2 |
| Psychoeducation App | Lure Discrimination Task (LDI) | Week 4 | 0.45 Lure Discrimination Index | Standard Deviation 0.22 |
| Psychoeducation App | Lure Discrimination Task (LDI) | baseline | 0.42 Lure Discrimination Index | Standard Deviation 0.21 |
| Psychoeducation App | Lure Discrimination Task (LDI) | 3-month follow-up | 0.46 Lure Discrimination Index | Standard Deviation 0.22 |
| Usual Care | Lure Discrimination Task (LDI) | baseline | 0.41 Lure Discrimination Index | Standard Deviation 0.21 |
| Usual Care | Lure Discrimination Task (LDI) | 3-month follow-up | 0.46 Lure Discrimination Index | Standard Deviation 0.22 |
| Usual Care | Lure Discrimination Task (LDI) | Week 4 | 0.44 Lure Discrimination Index | Standard Deviation 0.21 |
Other Pre-specified
Microbiome Alpha Diversity: Inverse Simpson (1/D)
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson is the probability that any two microbes are the same species, ranging from 0-1. Inverse Simpson (1 / Simpson) considers both richness and evenness. It places greater weight on the more abundant taxa. A higher inverse Simpson index suggests a more even distribution of taxa, with fewer dominant species. The inverse Simpson index is sensitive to the presence of dominant species and may emphasize diversity loss when one or a few species dominate the community.
Time frame: Baseline and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Inverse Simpson (1/D) | baseline | 42.62 1/D index | Standard Deviation 45.06 |
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Inverse Simpson (1/D) | 3-month follow-up | 43.59 1/D index | Standard Deviation 46.13 |
| Psychoeducation App | Microbiome Alpha Diversity: Inverse Simpson (1/D) | baseline | 42.54 1/D index | Standard Deviation 45.04 |
| Psychoeducation App | Microbiome Alpha Diversity: Inverse Simpson (1/D) | 3-month follow-up | 42.21 1/D index | Standard Deviation 44.66 |
| Usual Care | Microbiome Alpha Diversity: Inverse Simpson (1/D) | baseline | 43.41 1/D index | Standard Deviation 44.28 |
| Usual Care | Microbiome Alpha Diversity: Inverse Simpson (1/D) | 3-month follow-up | 44.43 1/D index | Standard Deviation 46.58 |
Other Pre-specified
Microbiome Alpha Diversity: Pielou Evenness Index (J)
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Pielou Evenness Index measures how evenly the individuals are distributed across the taxa in a sample. It is calculated by dividing the Shannon diversity index by the maximum possible value of the Shannon index (which occurs when all taxa are equally abundant). The Pielou index ranges from 0 (no evenness, where one species dominates) to 1 (perfect evenness, where all species are equally abundant).
Time frame: Baseline and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Pielou Evenness Index (J) | baseline | 0.74 J index | Standard Deviation 0.07 |
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Pielou Evenness Index (J) | 3-month follow-up | 0.74 J index | Standard Deviation 0.08 |
| Psychoeducation App | Microbiome Alpha Diversity: Pielou Evenness Index (J) | baseline | 0.74 J index | Standard Deviation 0.06 |
| Psychoeducation App | Microbiome Alpha Diversity: Pielou Evenness Index (J) | 3-month follow-up | 0.75 J index | Standard Deviation 0.06 |
| Usual Care | Microbiome Alpha Diversity: Pielou Evenness Index (J) | baseline | 0.74 J index | Standard Deviation 0.07 |
| Usual Care | Microbiome Alpha Diversity: Pielou Evenness Index (J) | 3-month follow-up | 0.75 J index | Standard Deviation 0.07 |
Other Pre-specified
Microbiome Alpha Diversity: Shannon Diversity Index (H')
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Shannon Diversity Index quantifies both the richness and the evenness of a community. It takes into account the number of taxa (richness) and their relative abundances (evenness). A higher Shannon index value indicates greater diversity, with both a high number of taxa and more even distribution of abundances among them. It is often used to assess the balance between species in a community. Typically ranges from 0-5 with higher numbers indicating increasing species diversity.
Time frame: Baseline and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Shannon Diversity Index (H') | baseline | 4.20 H' index | Standard Deviation 0.56 |
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Shannon Diversity Index (H') | 3-month follow-up | 4.19 H' index | Standard Deviation 0.61 |
| Psychoeducation App | Microbiome Alpha Diversity: Shannon Diversity Index (H') | baseline | 4.19 H' index | Standard Deviation 0.54 |
| Psychoeducation App | Microbiome Alpha Diversity: Shannon Diversity Index (H') | 3-month follow-up | 4.20 H' index | Standard Deviation 0.51 |
| Usual Care | Microbiome Alpha Diversity: Shannon Diversity Index (H') | baseline | 4.23 H' index | Standard Deviation 0.52 |
| Usual Care | Microbiome Alpha Diversity: Shannon Diversity Index (H') | 3-month follow-up | 4.24 H' index | Standard Deviation 0.53 |
Other Pre-specified
Microbiome Alpha Diversity: Simpson's Dominance Index (D)
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson's Dominance Index measures the probability that two randomly selected individuals from a community belong to the same species (or taxon). It ranges from 0 to 1, where 0 indicates perfect diversity (no dominance of a single species) and values closer to 1 indicate that one or a few species dominate the community. A lower Simpson's dominance score suggests a more diverse community, while a higher score indicates a community dominated by a few taxa.
Time frame: Baseline and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Simpson's Dominance Index (D) | baseline | 0.04 D index | Standard Deviation 0.03 |
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Simpson's Dominance Index (D) | 3-month follow-up | 0.04 D index | Standard Deviation 0.05 |
| Psychoeducation App | Microbiome Alpha Diversity: Simpson's Dominance Index (D) | baseline | 0.04 D index | Standard Deviation 0.02 |
| Psychoeducation App | Microbiome Alpha Diversity: Simpson's Dominance Index (D) | 3-month follow-up | 0.03 D index | Standard Deviation 0.02 |
| Usual Care | Microbiome Alpha Diversity: Simpson's Dominance Index (D) | baseline | 0.03 D index | Standard Deviation 0.02 |
| Usual Care | Microbiome Alpha Diversity: Simpson's Dominance Index (D) | 3-month follow-up | 0.03 D index | Standard Deviation 0.02 |
Other Pre-specified
Microbiome Alpha Diversity: Species Richness
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species.
Time frame: Baseline and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Species Richness | Observed at baseline | 308.78 species | Standard Deviation 122.78 |
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Species Richness | Observed at 3-month follow-up | 303.48 species | Standard Deviation 120.49 |
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Species Richness | Calculated at baseline | 309.89 species | Standard Deviation 123.3 |
| Healthy Minds Program (HMP) App | Microbiome Alpha Diversity: Species Richness | Calculated at 3-month follow-up | 304.58 species | Standard Deviation 120.94 |
| Psychoeducation App | Microbiome Alpha Diversity: Species Richness | Calculated at 3-month follow-up | 301.97 species | Standard Deviation 117.57 |
| Psychoeducation App | Microbiome Alpha Diversity: Species Richness | Observed at baseline | 300.80 species | Standard Deviation 117.87 |
| Psychoeducation App | Microbiome Alpha Diversity: Species Richness | Calculated at baseline | 301.88 species | Standard Deviation 118.55 |
| Psychoeducation App | Microbiome Alpha Diversity: Species Richness | Observed at 3-month follow-up | 300.88 species | Standard Deviation 116.95 |
| Usual Care | Microbiome Alpha Diversity: Species Richness | Calculated at 3-month follow-up | 312.64 species | Standard Deviation 115.77 |
| Usual Care | Microbiome Alpha Diversity: Species Richness | Observed at 3-month follow-up | 311.52 species | Standard Deviation 115.26 |
| Usual Care | Microbiome Alpha Diversity: Species Richness | Calculated at baseline | 313.87 species | Standard Deviation 114.89 |
| Usual Care | Microbiome Alpha Diversity: Species Richness | Observed at baseline | 312.68 species | Standard Deviation 114.24 |
Other Pre-specified
Mindfulness Adherence Questionnaire
The Mindfulness Adherence Questionnaire informal practice items are 6-items assessing the application of mindfulness during daily life (e.g., In your daily life, how much of the time were you practicing being gentle and compassionate toward yourself?). It is scored on a 7-point Likert scale where 0 = never to 6 = always. Total scores range from 0 to 42 where higher scores indicate greater informal mindfulness practice.
Time frame: week 1, week 2, week 3, week 4, and 3 month follow up
Population: Some participants did not provide data at all time points. The usual care arm was not surveyed for this measure per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Mindfulness Adherence Questionnaire | Week 2 | 20.61 score on a scale | Standard Deviation 6.15 |
| Healthy Minds Program (HMP) App | Mindfulness Adherence Questionnaire | Week 4 | 22.22 score on a scale | Standard Deviation 6.5 |
| Healthy Minds Program (HMP) App | Mindfulness Adherence Questionnaire | Week 3 | 21.56 score on a scale | Standard Deviation 6.49 |
| Healthy Minds Program (HMP) App | Mindfulness Adherence Questionnaire | 3-month follow-up | 21.87 score on a scale | Standard Deviation 7.24 |
| Healthy Minds Program (HMP) App | Mindfulness Adherence Questionnaire | Week 1 | 18.48 score on a scale | Standard Deviation 6.07 |
| Psychoeducation App | Mindfulness Adherence Questionnaire | 3-month follow-up | 21.96 score on a scale | Standard Deviation 7.05 |
| Psychoeducation App | Mindfulness Adherence Questionnaire | Week 1 | 18.93 score on a scale | Standard Deviation 6.27 |
| Psychoeducation App | Mindfulness Adherence Questionnaire | Week 2 | 20.35 score on a scale | Standard Deviation 6.47 |
| Psychoeducation App | Mindfulness Adherence Questionnaire | Week 3 | 21.09 score on a scale | Standard Deviation 6.48 |
| Psychoeducation App | Mindfulness Adherence Questionnaire | Week 4 | 21.82 score on a scale | Standard Deviation 6.95 |
Other Pre-specified
Negative Affect Word Use: Negative Sentiment
Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate more intense negative sentiment.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Negative Sentiment | Week 2 | 2.76 percent negative words used | Standard Deviation 1.84 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Negative Sentiment | Week 3 | 2.53 percent negative words used | Standard Deviation 1.86 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Negative Sentiment | Week 4 | 2.51 percent negative words used | Standard Deviation 1.81 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Negative Sentiment | 3-month follow-up | 2.72 percent negative words used | Standard Deviation 1.98 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Negative Sentiment | baseline | 2.94 percent negative words used | Standard Deviation 1.95 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Negative Sentiment | Week 1 | 2.79 percent negative words used | Standard Deviation 1.88 |
| Psychoeducation App | Negative Affect Word Use: Negative Sentiment | Week 1 | 2.90 percent negative words used | Standard Deviation 2.05 |
| Psychoeducation App | Negative Affect Word Use: Negative Sentiment | Week 2 | 2.82 percent negative words used | Standard Deviation 1.89 |
| Psychoeducation App | Negative Affect Word Use: Negative Sentiment | 3-month follow-up | 2.70 percent negative words used | Standard Deviation 1.9 |
| Psychoeducation App | Negative Affect Word Use: Negative Sentiment | baseline | 3.02 percent negative words used | Standard Deviation 1.97 |
| Psychoeducation App | Negative Affect Word Use: Negative Sentiment | Week 3 | 2.76 percent negative words used | Standard Deviation 1.87 |
| Psychoeducation App | Negative Affect Word Use: Negative Sentiment | Week 4 | 2.48 percent negative words used | Standard Deviation 1.79 |
| Usual Care | Negative Affect Word Use: Negative Sentiment | Week 3 | 3.06 percent negative words used | Standard Deviation 2.03 |
| Usual Care | Negative Affect Word Use: Negative Sentiment | Week 4 | 2.77 percent negative words used | Standard Deviation 2.07 |
| Usual Care | Negative Affect Word Use: Negative Sentiment | Week 1 | 2.86 percent negative words used | Standard Deviation 1.89 |
| Usual Care | Negative Affect Word Use: Negative Sentiment | 3-month follow-up | 2.89 percent negative words used | Standard Deviation 2.1 |
| Usual Care | Negative Affect Word Use: Negative Sentiment | Week 2 | 2.72 percent negative words used | Standard Deviation 1.9 |
| Usual Care | Negative Affect Word Use: Negative Sentiment | baseline | 2.87 percent negative words used | Standard Deviation 2.03 |
Other Pre-specified
Negative Affect Word Use: Positive Sentiment
Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate greater positive sentiment.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Positive Sentiment | baseline | 3.12 percent positive sentiment | Standard Deviation 2.12 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Positive Sentiment | Week 1 | 3.38 percent positive sentiment | Standard Deviation 2.21 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Positive Sentiment | Week 2 | 3.29 percent positive sentiment | Standard Deviation 2.02 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Positive Sentiment | Week 3 | 3.52 percent positive sentiment | Standard Deviation 2.16 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Positive Sentiment | Week 4 | 3.68 percent positive sentiment | Standard Deviation 2.32 |
| Healthy Minds Program (HMP) App | Negative Affect Word Use: Positive Sentiment | 3-month follow-up | 3.45 percent positive sentiment | Standard Deviation 2.27 |
| Psychoeducation App | Negative Affect Word Use: Positive Sentiment | 3-month follow-up | 3.40 percent positive sentiment | Standard Deviation 2.19 |
| Psychoeducation App | Negative Affect Word Use: Positive Sentiment | baseline | 3.26 percent positive sentiment | Standard Deviation 2.23 |
| Psychoeducation App | Negative Affect Word Use: Positive Sentiment | Week 3 | 3.39 percent positive sentiment | Standard Deviation 2.1 |
| Psychoeducation App | Negative Affect Word Use: Positive Sentiment | Week 4 | 3.73 percent positive sentiment | Standard Deviation 2.26 |
| Psychoeducation App | Negative Affect Word Use: Positive Sentiment | Week 1 | 3.21 percent positive sentiment | Standard Deviation 2.18 |
| Psychoeducation App | Negative Affect Word Use: Positive Sentiment | Week 2 | 3.48 percent positive sentiment | Standard Deviation 2.26 |
| Usual Care | Negative Affect Word Use: Positive Sentiment | Week 1 | 3.33 percent positive sentiment | Standard Deviation 2.34 |
| Usual Care | Negative Affect Word Use: Positive Sentiment | Week 2 | 3.41 percent positive sentiment | Standard Deviation 2.19 |
| Usual Care | Negative Affect Word Use: Positive Sentiment | 3-month follow-up | 3.55 percent positive sentiment | Standard Deviation 2.59 |
| Usual Care | Negative Affect Word Use: Positive Sentiment | Week 3 | 3.20 percent positive sentiment | Standard Deviation 2.22 |
| Usual Care | Negative Affect Word Use: Positive Sentiment | baseline | 3.32 percent positive sentiment | Standard Deviation 2.19 |
| Usual Care | Negative Affect Word Use: Positive Sentiment | Week 4 | 3.47 percent positive sentiment | Standard Deviation 2.34 |
Other Pre-specified
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. Increase in scores indicates increase is depression symptoms.
Time frame: Week 1, Week 2, Week 3, Week 4, 3-month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Minds Program (HMP) App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Overall (any time point) | 78 Participants |
| Healthy Minds Program (HMP) App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 1 | 28 Participants |
| Healthy Minds Program (HMP) App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 2 | 27 Participants |
| Healthy Minds Program (HMP) App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 3 | 30 Participants |
| Healthy Minds Program (HMP) App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 4 | 24 Participants |
| Healthy Minds Program (HMP) App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | 3-month follow-up | 20 Participants |
| Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | 3-month follow-up | 20 Participants |
| Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Overall (any time point) | 64 Participants |
| Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 3 | 21 Participants |
| Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 4 | 21 Participants |
| Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 1 | 27 Participants |
| Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 2 | 25 Participants |
| Usual Care | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 1 | 15 Participants |
| Usual Care | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 2 | 11 Participants |
| Usual Care | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | 3-month follow-up | 17 Participants |
| Usual Care | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 3 | 14 Participants |
| Usual Care | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Overall (any time point) | 44 Participants |
| Usual Care | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | Week 4 | 14 Participants |
Other Pre-specified
Self-Referential Pronoun Use
Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore indicators of self-referent, inflexible, & over-generalized thinking within natural language. Reported here is the I self-referential word frequency.
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Some participants did not provide data at all time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program (HMP) App | Self-Referential Pronoun Use | Baseline | 8.75 percent self referential words used | Standard Deviation 3.2 |
| Healthy Minds Program (HMP) App | Self-Referential Pronoun Use | Week 1 | 8.52 percent self referential words used | Standard Deviation 3.46 |
| Healthy Minds Program (HMP) App | Self-Referential Pronoun Use | Week 2 | 8.48 percent self referential words used | Standard Deviation 3.35 |
| Healthy Minds Program (HMP) App | Self-Referential Pronoun Use | Week 3 | 8.47 percent self referential words used | Standard Deviation 3.59 |
| Healthy Minds Program (HMP) App | Self-Referential Pronoun Use | Week 4 | 8.07 percent self referential words used | Standard Deviation 3.28 |
| Healthy Minds Program (HMP) App | Self-Referential Pronoun Use | 3-month follow-up | 8.44 percent self referential words used | Standard Deviation 3.48 |
| Psychoeducation App | Self-Referential Pronoun Use | 3-month follow-up | 8.28 percent self referential words used | Standard Deviation 3.32 |
| Psychoeducation App | Self-Referential Pronoun Use | Baseline | 8.63 percent self referential words used | Standard Deviation 3.43 |
| Psychoeducation App | Self-Referential Pronoun Use | Week 3 | 8.57 percent self referential words used | Standard Deviation 3.18 |
| Psychoeducation App | Self-Referential Pronoun Use | Week 4 | 8.28 percent self referential words used | Standard Deviation 3.46 |
| Psychoeducation App | Self-Referential Pronoun Use | Week 1 | 8.42 percent self referential words used | Standard Deviation 3.48 |
| Psychoeducation App | Self-Referential Pronoun Use | Week 2 | 8.08 percent self referential words used | Standard Deviation 3.24 |
| Usual Care | Self-Referential Pronoun Use | Week 1 | 8.75 percent self referential words used | Standard Deviation 2.95 |
| Usual Care | Self-Referential Pronoun Use | Week 2 | 8.23 percent self referential words used | Standard Deviation 3.42 |
| Usual Care | Self-Referential Pronoun Use | 3-month follow-up | 8.67 percent self referential words used | Standard Deviation 3.35 |
| Usual Care | Self-Referential Pronoun Use | Week 3 | 9.01 percent self referential words used | Standard Deviation 3.31 |
| Usual Care | Self-Referential Pronoun Use | Baseline | 8.47 percent self referential words used | Standard Deviation 3.46 |
| Usual Care | Self-Referential Pronoun Use | Week 4 | 8.81 percent self referential words used | Standard Deviation 3.41 |
Other Pre-specified
Treatment Expectancies
The Treatment Expectancies is a 6-item scale assessing how much participants believed the training program was helpful to them. Items assess how participants think (e.g., At this point, how logical does the program offered to you seem?) and feel (e.g., At this point, how much do you really feel that the program helped you to reduce your stress symptoms?). Items are scored on either a 9-point Likert scale (e.g., 1 = not at all logical to 9 = very logical) or on a percentage (At the end of the program, how much improvement in your symptoms do you really feel occurred?, 0% to 100%). Higher scores reflect higher treatment expectancies.
Time frame: 3-month follow-up
Population: The usual care arm was not surveyed for this measure per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Minds Program (HMP) App | Treatment Expectancies | 35.07 score on a scale | Standard Deviation 11.28 |
| Psychoeducation App | Treatment Expectancies | 32.13 score on a scale | Standard Deviation 11.98 |