Depression, Psychological Distress
Conditions
Keywords
inflammation, microbiota, alpha diversity
Brief summary
The central aim of this pilot study is to compare markers of inflammation and gut microbial diversity with users 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 300 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 mediation 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. Specific Aims: * Aim 1. Determine the feasibility and acceptability of assessing inflammatory activity and gut microbiome within the context of a fully remote randomized controlled trial (RCT). Participants with elevated depression symptoms from an RCT (n = 1,100; registered to NCT05183867) comparing the Healthy Minds Program (HMP) app with an active control (HMP with didactic content only) and wait-list will be invited to provide dried blood spots (DBS) for inflammatory protein analysis and fecal samples for gut microbial analysis at baseline and 3-month follow-up. Hypotheses: It will be feasible to recruit 300 participants to provide DBS and fecal samples and 80% will provide samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants. * Aim 2. Characterize the association between self-reports of well-being, inflammatory activity at baseline, and microbiota diversity at baseline. Hypotheses: Well-being will correlate inversely with both protein biomarkers of inflammation (CRP, IL-6) and mRNA-derived indicators of pro-inflammatory transcriptional activity. Well-being will correlate positively with alpha diversity of the gut microbiome. These associations will not be moderated by participant race/ethnicity. * Aim 3. Evaluate intervention effects on inflammatory activity and microbiota diversity. Hypotheses: Participants randomized to HMP or the active control will show larger reductions in inflammation vs. wait-list at 3-month follow-up and larger increases in alpha diversity of the gut microbiome vs. wait-list at 3-month follow-up. HMP will show larger reductions in inflammation vs. active control at 3-month follow-up and larger increases in alpha diversity vs. active control at 3-month follow-up.
Interventions
DEVICEHealthy Minds Program
HMP is a 4-week mobile health (mHealth) meditation training program.
OTHERPsychoeducation app
Psychoeducation app
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 and pre-baseline interview * 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 |
|---|---|---|
| Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Baseline and 3 month follow-up | Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants. |
| Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Baseline and 3 month follow-up | Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 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. |
| Change in 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. |
| Change in 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). |
| Change in 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. |
| Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | Baseline and 3 month follow-up | Dried blood spot samples will be used to measure 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). |
| Change in 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. |
| Change in 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. |
| Change in Inflammatory Biomarkers: C-reactive Protein | Baseline and 3 month follow-up | Dried blood spot samples will be used to measure 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). |
| Change in 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | 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. Increase in scores indicates increase is depression symptoms. |
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 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. | 120 |
| 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. | 122 |
| Usual Care Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. | 58 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Healthy Minds Program (HMP) App | Psychoeducation App | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 40.26 years STANDARD_DEVIATION 11.77 | 38.70 years STANDARD_DEVIATION 11.76 | 43.57 years STANDARD_DEVIATION 12 | 40.26 years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Non-Hispanic White | 90 Participants | 98 Participants | 38 Participants | 226 Participants |
| Race/Ethnicity, Customized Racial/Ethnic Minority | 30 Participants | 24 Participants | 20 Participants | 74 Participants |
| Region of Enrollment United States | 120 participants | 122 participants | 58 participants | 300 participants |
| Sex/Gender, Customized Man | 23 Participants | 29 Participants | 11 Participants | 63 Participants |
| Sex/Gender, Customized Not Provided | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Other | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Sex/Gender, Customized Woman | 94 Participants | 91 Participants | 46 Participants | 231 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 122 | 0 / 58 |
| other Total, other adverse events | 24 / 120 | 15 / 122 | 10 / 58 |
| serious Total, serious adverse events | 0 / 120 | 0 / 122 | 0 / 58 |
Outcome results
Primary
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
Time frame: Baseline and 3 month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-Hispanic White: HMP App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at 3-month Follow up | 68 Participants |
| Non-Hispanic White: HMP App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at Baseline | 89 Participants |
| Non-Hispanic White: HMP App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate for both time points | 68 Participants |
| Racial / Ethnic Minority: HMP App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at 3-month Follow up | 23 Participants |
| Racial / Ethnic Minority: HMP App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at Baseline | 29 Participants |
| Racial / Ethnic Minority: HMP App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate for both time points | 23 Participants |
| Non-Hispanic White: Psychoeducation App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at 3-month Follow up | 72 Participants |
| Non-Hispanic White: Psychoeducation App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at Baseline | 98 Participants |
| Non-Hispanic White: Psychoeducation App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate for both time points | 72 Participants |
| Racial / Ethnic Minority: Psychoeducation App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at 3-month Follow up | 20 Participants |
| Racial / Ethnic Minority: Psychoeducation App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at Baseline | 24 Participants |
| Racial / Ethnic Minority: Psychoeducation App | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate for both time points | 20 Participants |
| Non-Hispanic: Usual Care | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at 3-month Follow up | 31 Participants |
| Non-Hispanic: Usual Care | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at Baseline | 38 Participants |
| Non-Hispanic: Usual Care | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate for both time points | 31 Participants |
| Racial / Ethnic Minority: Usual Care | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at Baseline | 19 Participants |
| Racial / Ethnic Minority: Usual Care | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate for both time points | 16 Participants |
| Racial / Ethnic Minority: Usual Care | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Return Rate at 3-month Follow up | 16 Participants |
Primary
Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
Time frame: Baseline and 3 month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-Hispanic White: HMP App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at 3-month follow up | 69 Participants |
| Non-Hispanic White: HMP App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at Baseline | 90 Participants |
| Non-Hispanic White: HMP App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate both time points | 69 Participants |
| Racial / Ethnic Minority: HMP App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at 3-month follow up | 24 Participants |
| Racial / Ethnic Minority: HMP App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at Baseline | 30 Participants |
| Racial / Ethnic Minority: HMP App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate both time points | 24 Participants |
| Non-Hispanic White: Psychoeducation App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at 3-month follow up | 72 Participants |
| Non-Hispanic White: Psychoeducation App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at Baseline | 98 Participants |
| Non-Hispanic White: Psychoeducation App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate both time points | 72 Participants |
| Racial / Ethnic Minority: Psychoeducation App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at 3-month follow up | 20 Participants |
| Racial / Ethnic Minority: Psychoeducation App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at Baseline | 24 Participants |
| Racial / Ethnic Minority: Psychoeducation App | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate both time points | 20 Participants |
| Non-Hispanic: Usual Care | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at 3-month follow up | 30 Participants |
| Non-Hispanic: Usual Care | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at Baseline | 37 Participants |
| Non-Hispanic: Usual Care | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate both time points | 29 Participants |
| Racial / Ethnic Minority: Usual Care | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at Baseline | 20 Participants |
| Racial / Ethnic Minority: Usual Care | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate both time points | 17 Participants |
| Racial / Ethnic Minority: Usual Care | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Return Rate at 3-month follow up | 17 Participants |
Secondary
Change in 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: Survey participation dropped over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Baseline | 9.80 score on a scale | Standard Deviation 4.74 |
| Non-Hispanic White: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 1 | 9.53 score on a scale | Standard Deviation 5.02 |
| Non-Hispanic White: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 2 | 8.06 score on a scale | Standard Deviation 4.87 |
| Non-Hispanic White: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 3 | 7.78 score on a scale | Standard Deviation 4.68 |
| Non-Hispanic White: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 4 | 7.17 score on a scale | Standard Deviation 4.89 |
| Non-Hispanic White: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | 3-month follow up | 6.78 score on a scale | Standard Deviation 4.99 |
| Racial / Ethnic Minority: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | 3-month follow up | 7.26 score on a scale | Standard Deviation 5.13 |
| Racial / Ethnic Minority: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Baseline | 9.91 score on a scale | Standard Deviation 5.03 |
| Racial / Ethnic Minority: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 3 | 7.88 score on a scale | Standard Deviation 4.87 |
| Racial / Ethnic Minority: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 4 | 7.44 score on a scale | Standard Deviation 4.94 |
| Racial / Ethnic Minority: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 1 | 9.30 score on a scale | Standard Deviation 5.1 |
| Racial / Ethnic Minority: HMP App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 2 | 8.35 score on a scale | Standard Deviation 4.79 |
| Non-Hispanic White: Psychoeducation App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 1 | 9.35 score on a scale | Standard Deviation 4.7 |
| Non-Hispanic White: Psychoeducation App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 2 | 8.77 score on a scale | Standard Deviation 4.49 |
| Non-Hispanic White: Psychoeducation App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | 3-month follow up | 7.81 score on a scale | Standard Deviation 4.54 |
| Non-Hispanic White: Psychoeducation App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 3 | 9.14 score on a scale | Standard Deviation 4.43 |
| Non-Hispanic White: Psychoeducation App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Baseline | 9.45 score on a scale | Standard Deviation 4.57 |
| Non-Hispanic White: Psychoeducation App | Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | Week 4 | 8.98 score on a scale | Standard Deviation 4.38 |
Secondary
Change in 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: Survey participation dropped over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Baseline | 55.61 score on a scale | Standard Deviation 16.47 |
| Non-Hispanic White: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 1 | 56.31 score on a scale | Standard Deviation 17.51 |
| Non-Hispanic White: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 2 | 60.39 score on a scale | Standard Deviation 16.01 |
| Non-Hispanic White: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 3 | 62.11 score on a scale | Standard Deviation 16.65 |
| Non-Hispanic White: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 4 | 63.64 score on a scale | Standard Deviation 17.73 |
| Non-Hispanic White: HMP App | Change in Flourishing Measured by the Flourishing Index Score | 3-month follow up | 65.01 score on a scale | Standard Deviation 18.34 |
| Racial / Ethnic Minority: HMP App | Change in Flourishing Measured by the Flourishing Index Score | 3-month follow up | 63.47 score on a scale | Standard Deviation 16.84 |
| Racial / Ethnic Minority: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Baseline | 56.4 score on a scale | Standard Deviation 16.75 |
| Racial / Ethnic Minority: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 3 | 61.12 score on a scale | Standard Deviation 15.53 |
| Racial / Ethnic Minority: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 4 | 63.31 score on a scale | Standard Deviation 15.75 |
| Racial / Ethnic Minority: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 1 | 56.5 score on a scale | Standard Deviation 14.36 |
| Racial / Ethnic Minority: HMP App | Change in Flourishing Measured by the Flourishing Index Score | Week 2 | 59.19 score on a scale | Standard Deviation 14.92 |
| Non-Hispanic White: Psychoeducation App | Change in Flourishing Measured by the Flourishing Index Score | Week 1 | 57.62 score on a scale | Standard Deviation 14.02 |
| Non-Hispanic White: Psychoeducation App | Change in Flourishing Measured by the Flourishing Index Score | Week 2 | 57.26 score on a scale | Standard Deviation 16.01 |
| Non-Hispanic White: Psychoeducation App | Change in Flourishing Measured by the Flourishing Index Score | 3-month follow up | 61.48 score on a scale | Standard Deviation 14.09 |
| Non-Hispanic White: Psychoeducation App | Change in Flourishing Measured by the Flourishing Index Score | Week 3 | 57.65 score on a scale | Standard Deviation 15.35 |
| Non-Hispanic White: Psychoeducation App | Change in Flourishing Measured by the Flourishing Index Score | Baseline | 57.14 score on a scale | Standard Deviation 16.54 |
| Non-Hispanic White: Psychoeducation App | Change in Flourishing Measured by the Flourishing Index Score | Week 4 | 59.10 score on a scale | Standard Deviation 15.85 |
Secondary
Change in Inflammatory Biomarkers: C-reactive Protein
Dried blood spot samples will be used to measure 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: only those who return their samples at both time points were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: C-reactive Protein | baseline | 2.26 mg/L | Standard Deviation 4.17 |
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: C-reactive Protein | 3-month follow up | 2.62 mg/L | Standard Deviation 4.44 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: C-reactive Protein | baseline | 2.40 mg/L | Standard Deviation 3.46 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: C-reactive Protein | 3-month follow up | 3.28 mg/L | Standard Deviation 5.3 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: C-reactive Protein | baseline | 2.98 mg/L | Standard Deviation 4.67 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: C-reactive Protein | 3-month follow up | 3.10 mg/L | Standard Deviation 4.33 |
Secondary
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
Dried blood spot samples will be used to measure 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: only those who return their samples at both time points were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | TNF-Alpha baseline | 2.01 pg/mL | Standard Deviation 5.58 |
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | TNF-Alpha 3-month follow up | 1.73 pg/mL | Standard Deviation 0.93 |
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-6 baseline | 1.79 pg/mL | Standard Deviation 13.2 |
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-6 3-month follow up | 0.98 pg/mL | Standard Deviation 6.58 |
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-10 baseline | 0.11 pg/mL | Standard Deviation 0.12 |
| Non-Hispanic White: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-10 3-month follow up | 0.13 pg/mL | Standard Deviation 0.18 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-10 3-month follow up | 0.16 pg/mL | Standard Deviation 0.26 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | TNF-Alpha baseline | 1.54 pg/mL | Standard Deviation 0.88 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-6 3-month follow up | 0.42 pg/mL | Standard Deviation 0.83 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-10 baseline | 0.10 pg/mL | Standard Deviation 0.14 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | TNF-Alpha 3-month follow up | 1.87 pg/mL | Standard Deviation 0.84 |
| Racial / Ethnic Minority: HMP App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-6 baseline | 0.26 pg/mL | Standard Deviation 0.2 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | TNF-Alpha 3-month follow up | 1.98 pg/mL | Standard Deviation 1.15 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-6 baseline | 0.34 pg/mL | Standard Deviation 0.39 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-10 3-month follow up | 0.11 pg/mL | Standard Deviation 0.09 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-6 3-month follow up | 0.98 pg/mL | Standard Deviation 4.1 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | TNF-Alpha baseline | 1.66 pg/mL | Standard Deviation 0.67 |
| Non-Hispanic White: Psychoeducation App | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | IL-10 baseline | 0.08 pg/mL | Standard Deviation 0.07 |
Secondary
Change in 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: Samples were not received from all participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Inverse Simpson (1/D) | Inverse Simpson at baseline | 62.75 1/D index | Standard Deviation 80.39 |
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Inverse Simpson (1/D) | Inverse Simpson at 3-month follow up | 62.23 1/D index | Standard Deviation 78.81 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Inverse Simpson (1/D) | Inverse Simpson at baseline | 62.18 1/D index | Standard Deviation 77.51 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Inverse Simpson (1/D) | Inverse Simpson at 3-month follow up | 64.07 1/D index | Standard Deviation 75.86 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Inverse Simpson (1/D) | Inverse Simpson at baseline | 60.73 1/D index | Standard Deviation 70.38 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Inverse Simpson (1/D) | Inverse Simpson at 3-month follow up | 66.58 1/D index | Standard Deviation 75.16 |
Secondary
Change in 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: Samples were not received from all participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Pielou Evenness Index (J) | Evenness Pielou baseline | 0.78 J index | Standard Deviation 0.09 |
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Pielou Evenness Index (J) | Evenness Pielou at 3-month follow up | 0.78 J index | Standard Deviation 0.09 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Pielou Evenness Index (J) | Evenness Pielou baseline | 0.78 J index | Standard Deviation 0.09 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Pielou Evenness Index (J) | Evenness Pielou at 3-month follow up | 0.79 J index | Standard Deviation 0.09 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Pielou Evenness Index (J) | Evenness Pielou baseline | 0.78 J index | Standard Deviation 0.09 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Pielou Evenness Index (J) | Evenness Pielou at 3-month follow up | 0.79 J index | Standard Deviation 0.09 |
Secondary
Change in 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: Samples were not received from all participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Shannon Diversity Index (H') | diversity at baseline | 4.28 H' index | Standard Deviation 0.78 |
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Shannon Diversity Index (H') | diversity at 3-month follow up | 4.26 H' index | Standard Deviation 0.76 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Shannon Diversity Index (H') | diversity at baseline | 4.28 H' index | Standard Deviation 0.74 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Shannon Diversity Index (H') | diversity at 3-month follow up | 4.33 H' index | Standard Deviation 0.74 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Shannon Diversity Index (H') | diversity at baseline | 4.35 H' index | Standard Deviation 0.72 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Shannon Diversity Index (H') | diversity at 3-month follow up | 4.40 H' index | Standard Deviation 0.73 |
Secondary
Change in 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: Samples were not received from all participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Simpson's Dominance at baseline | 0.03 D index | Standard Deviation 0.02 |
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Simpson's Dominance at 3-month follow up | 0.04 D index | Standard Deviation 0.02 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Simpson's Dominance at baseline | 0.04 D index | Standard Deviation 0.03 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Simpson's Dominance at 3-month follow up | 0.03 D index | Standard Deviation 0.02 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Simpson's Dominance at baseline | 0.03 D index | Standard Deviation 0.03 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Simpson's Dominance at 3-month follow up | 0.03 D index | Standard Deviation 0.02 |
Secondary
Change in 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: Samples were not received from all participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Observed at baseline | 261.47 species | Standard Deviation 143.66 |
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Observed at 3-month follow up | 257.34 species | Standard Deviation 133.74 |
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Calculated at baseline | 261.64 species | Standard Deviation 143.82 |
| Non-Hispanic White: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Calculated at 3-month follow up | 257.57 species | Standard Deviation 133.91 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Calculated at 3-month follow up | 278.75 species | Standard Deviation 144.07 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Observed at baseline | 271.59 species | Standard Deviation 139.46 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Calculated at baseline | 271.84 species | Standard Deviation 139.52 |
| Racial / Ethnic Minority: HMP App | Change in Microbiome Alpha Diversity: Species Richness | Observed at 3-month follow up | 278.55 species | Standard Deviation 143.96 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Species Richness | Calculated at 3-month follow up | 295.96 species | Standard Deviation 148.76 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Species Richness | Observed at 3-month follow up | 295.67 species | Standard Deviation 148.78 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Species Richness | Calculated at baseline | 294.98 species | Standard Deviation 130.68 |
| Non-Hispanic White: Psychoeducation App | Change in Microbiome Alpha Diversity: Species Richness | Observed at baseline | 294.22 species | Standard Deviation 130.35 |
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: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Population: Survey participation dropped over time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-Hispanic White: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 4 | 8 Participants |
| Non-Hispanic White: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 3 | 9 Participants |
| Non-Hispanic White: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 1 | 11 Participants |
| Non-Hispanic White: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 2 | 7 Participants |
| Non-Hispanic White: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to 3-month follow up | 8 Participants |
| Racial / Ethnic Minority: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 3 | 6 Participants |
| Racial / Ethnic Minority: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 1 | 8 Participants |
| Racial / Ethnic Minority: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 2 | 3 Participants |
| Racial / Ethnic Minority: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 4 | 6 Participants |
| Racial / Ethnic Minority: HMP App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to 3-month follow up | 6 Participants |
| Non-Hispanic White: Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to 3-month follow up | 3 Participants |
| Non-Hispanic White: Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 4 | 7 Participants |
| Non-Hispanic White: Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 1 | 6 Participants |
| Non-Hispanic White: Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 3 | 5 Participants |
| Non-Hispanic White: Psychoeducation App | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | baseline to Week 2 | 4 Participants |