Anxiety, Depression, Psychological Distress
Conditions
Keywords
depression, anxiety, behavioral symptoms
Brief summary
The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks.
Detailed description
Depression and anxiety are highly common, but access to evidence-based treatments is limited. Meditation training delivered through mobile health (mHealth) technology may increase access to effective strategies. However, the necessary dosage of meditation practice to produce benefits is unknown. This project will investigate the feasibility, acceptability, and preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. Further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (EMA).
Interventions
BEHAVIORALHMP app
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 has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized to two groups in a 1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Access to a smartphone or device capable of downloading HMP app * Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks * Able to speak, read, and write in English * PROMIS Depression or PROMIS Anxiety \>55
Exclusion criteria
* Meditation retreat experience * Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months) * Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course * PROMIS Depression \>70 * AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App | Baseline to post-test (week 4) | Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app |
| HMP App Utilization: Number of Activities | Baseline to post-test (week 4) | — |
| HMP App Utilization: Days | Baseline to post-test (week 4) | Number of days the app was accessed. |
| HMP App Utilization: Minutes | Baseline to post-test (week 4) | Minutes of meditation practice completed |
| Change in Attitudes Towards Psychological Online Interventions (ATPOI) | Baseline, and post-test (week 4) | The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions. |
| Modified System Usability Scale (MSUS) | Post-test (week 4) | The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability. |
| Number of Participants Completing Practices ≥50% of Days | Baseline to post-test (week 4) | Number of participants completing practices ≥50% of days |
| Study Completion Rate | Baseline to post-test (week 4) | Percentage of participants completing pre- and post-test measures |
| Percentage of EMA Completed | Baseline to post-test (week 4) | Percentage of EMA assessments that were completed |
| Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days | Baseline to post-test (week 4) | Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Healthy Minds Index (HM Index): Insight | Baseline, and post-test (week 4) | The HM Index assesses 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. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight. |
| Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety | Baseline, and post-test (week 4) | Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety. |
| Change in Healthy Minds Index (HM Index): Awareness | Baseline, and post-test (week 4) | The HM Index assesses 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. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness. |
| Change in Healthy Minds Index (HM Index): Connection | Baseline, and post-test (week 4) | The HM Index assesses 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. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection. |
| Change in Healthy Minds Index (HM Index): Purpose | Baseline, and post-test (week 4) | The HM Index assesses 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. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose. |
| Change in Wellbeing Growth Mindset | Baseline, and post-test (week 4) | Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable). |
| Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale | Baseline, and post-test (week 4) | FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness. |
| Change in NIH Toolbox Loneliness | Baseline, and post-test (week 4) | NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness. |
| Change in Experiences Questionnaire (EQ) Decentering Subscale | Baseline, and post-test (week 4) | Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering. |
| Change in Meaning in Life Questionnaire (MLQ) Presence Subscale | Baseline, and post-test (week 4) | MLQ Presence is a 5-item questionnaire assessing the presence of meaning in life. It is scored on a 1- to 7-point Likert scale where 1 = absolutely untrue and 7 = absolutely true. Mean scores are reported for a total range from 1 to 7 where higher scores indicate greater presence of meaning in life. |
| Change in PROMIS Sleep Disturbance | Baseline, and post-test (week 4) | Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance. |
| Count of Participant Responses to Adverse Event Relevant Survey Item | up to 4 weeks | Participants were asked a single survey item to assess their meditation experience. The query was I had challenging, difficult, or distressing experiences as a result of my meditation during this study. Participants chose from the following responses: Never, Rarely, Occasionally, Regularly, or Frequently. Count of participants in each arm answering each response is reported here. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in EMA-assessed Insight | 4 times per day from baseline to post-test (week 4) | A single item assessing insight is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware |
| Change in EMA-assessed Decentering | 4 times per day from baseline to post-test (week 4) | A single item assessing decentering (i.e., experiencing thoughts more as events than direct reflection of reality) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
| Change in EMA-assessed Connection With Others | 4 times per day from baseline to post-test (week 4) | A single item assessing connection with others is scored on a 1- to 5-point Likert scale where 1 = not often at all and 5 = extremely often |
| Change in EMA-assessed Loneliness | 4 times per day from baseline to post-test (week 4) | A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
| Change in EMA-assessed Mindfulness of Feelings / Emotions | 4 times per day from baseline to post-test (week 4) | A single item assessing awareness of feelings is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware. |
| Change in EMA-assessed Informal Practice | 4 times per day from baseline to post-test (week 4) | A single item assessing application of meditation techniques in daily life (informal practice) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
| Change in Pre- and Post-practice Positive Affect | Before and after meditation practices between baseline and post-test (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. |
| Change in Pre- and Post-practice Negative Affect | Before and after meditation practices between baseline and post-test (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 |
| Change in Post-practice Focus | Before and after meditation practices between baseline and post-test (week 4) | A single item assessing focus during meditation is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time |
| Digital Working Alliance Inventory (DWAI) | Post-test (week 4) | The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance. |
| Change in EMA-assessed Mindfulness of Activities | 4 times per day from baseline to post-test (week 4) | A single item mindfulness of activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
| Change in EMA-assessed Rumination | 4 times per day from baseline to post-test (week 4) | A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much |
| Change in EMA-assessed Personal Values / Meaning | 4 times per day from baseline to post-test (week 4) | A single item assessing reflection of personal values in current activity is scored on a 1- to 5-point Likert scale where 1 = not at all reflected and 5 = extremely reflected. |
| Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items) | 4 times per day from baseline to post-test (week 4) | A single item reflecting depression and a single item reflecting anxiety are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
| Change in EMA-assessed Stressor Exposure | 4 times per day from baseline to post-test (week 4) | A single item assessing stressor exposure is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
| Change in EMA-assessed Purpose | 4 times per day from baseline to post-test (week 4) | A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from February 2022 to June 2022.
Participants by arm
| Arm | Count |
|---|---|
| 5-minute App Usage Participants will be asked to use the HMP app for 5-minutes per day.
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 has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. | 46 |
| 15-minute App Usage Participants will be asked to use the HMP app for 15-minutes per day.
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 has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. | 46 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | 5-minute App Usage | 15-minute App Usage |
|---|---|---|---|
| Age, Continuous | 31.28 years STANDARD_DEVIATION 13.12 | 30.72 years STANDARD_DEVIATION 11.48 | 31.85 years STANDARD_DEVIATION 14.68 |
| Race/Ethnicity, Customized American Indian | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 18 Participants | 9 Participants | 9 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic White | 8 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Multiracial | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 29 Participants | 27 Participants |
| Region of Enrollment United States | 92 participants | 46 participants | 46 participants |
| Sex/Gender, Customized Female | 75 Participants | 41 Participants | 34 Participants |
| Sex/Gender, Customized Male | 13 Participants | 5 Participants | 8 Participants |
| Sex/Gender, Customized Other Gender | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
Change in Attitudes Towards Psychological Online Interventions (ATPOI)
The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Attitudes Towards Psychological Online Interventions (ATPOI) | Change | 0.15 score on a scale | Standard Deviation 0.47 |
| 5-minute App Usage | Change in Attitudes Towards Psychological Online Interventions (ATPOI) | T1 Baseline | 3.30 score on a scale | Standard Deviation 0.39 |
| 5-minute App Usage | Change in Attitudes Towards Psychological Online Interventions (ATPOI) | T2 Post-Test Week 4 | 3.45 score on a scale | Standard Deviation 0.5 |
| 15-minute App Usage | Change in Attitudes Towards Psychological Online Interventions (ATPOI) | Change | 0.27 score on a scale | Standard Deviation 0.44 |
| 15-minute App Usage | Change in Attitudes Towards Psychological Online Interventions (ATPOI) | T1 Baseline | 3.20 score on a scale | Standard Deviation 0.36 |
| 15-minute App Usage | Change in Attitudes Towards Psychological Online Interventions (ATPOI) | T2 Post-Test Week 4 | 3.47 score on a scale | Standard Deviation 0.64 |
Primary
Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days
Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app.
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5-minute App Usage | Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days | 22 Participants |
| 15-minute App Usage | Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days | 16 Participants |
Primary
HMP App Utilization: Days
Number of days the app was accessed.
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5-minute App Usage | HMP App Utilization: Days | 17.28 days | Standard Deviation 7 |
| 15-minute App Usage | HMP App Utilization: Days | 14.72 days | Standard Deviation 7.89 |
Primary
HMP App Utilization: Minutes
Minutes of meditation practice completed
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5-minute App Usage | HMP App Utilization: Minutes | 100.85 minutes | Standard Deviation 66.13 |
| 15-minute App Usage | HMP App Utilization: Minutes | 201.76 minutes | Standard Deviation 144.61 |
Primary
HMP App Utilization: Number of Activities
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5-minute App Usage | HMP App Utilization: Number of Activities | 57.65 activities | Standard Deviation 32.4 |
| 15-minute App Usage | HMP App Utilization: Number of Activities | 51.43 activities | Standard Deviation 44.91 |
Primary
Modified System Usability Scale (MSUS)
The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability.
Time frame: Post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5-minute App Usage | Modified System Usability Scale (MSUS) | 84.56 score on a scale | Standard Deviation 10.86 |
| 15-minute App Usage | Modified System Usability Scale (MSUS) | 83.66 score on a scale | Standard Deviation 14.21 |
Primary
Number of Participants Completing Practices ≥50% of Days
Number of participants completing practices ≥50% of days
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5-minute App Usage | Number of Participants Completing Practices ≥50% of Days | 32 Participants |
| 15-minute App Usage | Number of Participants Completing Practices ≥50% of Days | 26 Participants |
Primary
Percentage of EMA Completed
Percentage of EMA assessments that were completed
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5-minute App Usage | Percentage of EMA Completed | 82.71 percentage of EMA assessments complete | Standard Deviation 32.82 |
| 15-minute App Usage | Percentage of EMA Completed | 78.61 percentage of EMA assessments complete | Standard Deviation 41 |
Primary
Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App
Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5-minute App Usage | Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App | 46 Participants |
| 15-minute App Usage | Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App | 46 Participants |
Primary
Study Completion Rate
Percentage of participants completing pre- and post-test measures
Time frame: Baseline to post-test (week 4)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5-minute App Usage | Study Completion Rate | 45 Participants |
| 15-minute App Usage | Study Completion Rate | 44 Participants |
Secondary
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety
Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety | T1 baseline | 60.93 T-score | Standard Deviation 5.38 |
| 5-minute App Usage | Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety | Change | -3.58 T-score | Standard Deviation 4.32 |
| 5-minute App Usage | Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety | T2 post-test (week 4) | 57.28 T-score | Standard Deviation 5.63 |
| 15-minute App Usage | Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety | T1 baseline | 61.08 T-score | Standard Deviation 5.24 |
| 15-minute App Usage | Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety | T2 post-test (week 4) | 56.78 T-score | Standard Deviation 6.02 |
| 15-minute App Usage | Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety | Change | -4.44 T-score | Standard Deviation 7.07 |
Secondary
Change in Experiences Questionnaire (EQ) Decentering Subscale
Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Experiences Questionnaire (EQ) Decentering Subscale | T1 Baseline | 2.85 score on a scale | Standard Deviation 0.53 |
| 5-minute App Usage | Change in Experiences Questionnaire (EQ) Decentering Subscale | T2 Post-test Week 4 | 3.30 score on a scale | Standard Deviation 0.68 |
| 5-minute App Usage | Change in Experiences Questionnaire (EQ) Decentering Subscale | Change | 0.46 score on a scale | Standard Deviation 0.55 |
| 15-minute App Usage | Change in Experiences Questionnaire (EQ) Decentering Subscale | T1 Baseline | 3.06 score on a scale | Standard Deviation 0.55 |
| 15-minute App Usage | Change in Experiences Questionnaire (EQ) Decentering Subscale | T2 Post-test Week 4 | 3.56 score on a scale | Standard Deviation 0.63 |
| 15-minute App Usage | Change in Experiences Questionnaire (EQ) Decentering Subscale | Change | 0.52 score on a scale | Standard Deviation 0.71 |
Secondary
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale
FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale | T1 Baseline | 3.04 score on a scale | Standard Deviation 0.59 |
| 5-minute App Usage | Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale | Change | 0.16 score on a scale | Standard Deviation 0.63 |
| 5-minute App Usage | Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale | T2 Post-test Week 4 | 3.22 score on a scale | Standard Deviation 0.71 |
| 15-minute App Usage | Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale | T1 Baseline | 2.91 score on a scale | Standard Deviation 0.91 |
| 15-minute App Usage | Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale | Change | 0.37 score on a scale | Standard Deviation 0.81 |
| 15-minute App Usage | Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale | T2 Post-test Week 4 | 3.30 score on a scale | Standard Deviation 0.74 |
Secondary
Change in Healthy Minds Index (HM Index): Awareness
The HM Index assesses 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. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Awareness | T1 Baseline | 3.29 score on a scale | Standard Deviation 0.53 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Awareness | T2 Post-Test Week 4 | 3.42 score on a scale | Standard Deviation 0.66 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Awareness | Change | 0.13 score on a scale | Standard Deviation 0.65 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Awareness | T1 Baseline | 3.26 score on a scale | Standard Deviation 0.67 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Awareness | T2 Post-Test Week 4 | 3.40 score on a scale | Standard Deviation 0.7 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Awareness | Change | 0.12 score on a scale | Standard Deviation 0.77 |
Secondary
Change in Healthy Minds Index (HM Index): Connection
The HM Index assesses 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. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Connection | T2 Post-Test Week 4 | 3.72 score on a scale | Standard Deviation 0.71 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Connection | Change | 0.16 score on a scale | Standard Deviation 0.48 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Connection | T1 Baseline | 3.56 score on a scale | Standard Deviation 0.58 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Connection | T1 Baseline | 3.55 score on a scale | Standard Deviation 0.55 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Connection | T2 Post-Test Week 4 | 3.87 score on a scale | Standard Deviation 0.44 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Connection | Change | 0.34 score on a scale | Standard Deviation 0.48 |
Secondary
Change in Healthy Minds Index (HM Index): Insight
The HM Index assesses 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. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Insight | T2 Post-Test Week 4 | 3.11 score on a scale | Standard Deviation 0.76 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Insight | Change | 0.27 score on a scale | Standard Deviation 0.76 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Insight | T1 Baseline | 2.86 score on a scale | Standard Deviation 0.68 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Insight | T2 Post-Test Week 4 | 3.33 score on a scale | Standard Deviation 0.65 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Insight | Change | 0.56 score on a scale | Standard Deviation 0.8 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Insight | T1 Baseline | 2.77 score on a scale | Standard Deviation 0.6 |
Secondary
Change in Healthy Minds Index (HM Index): Purpose
The HM Index assesses 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. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Purpose | T1 Baseline | 3.43 score on a scale | Standard Deviation 0.85 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Purpose | T2 Post-Test Week 4 | 3.80 score on a scale | Standard Deviation 0.79 |
| 5-minute App Usage | Change in Healthy Minds Index (HM Index): Purpose | Change | 0.38 score on a scale | Standard Deviation 0.9 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Purpose | Change | 0.40 score on a scale | Standard Deviation 0.94 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Purpose | T1 Baseline | 3.49 score on a scale | Standard Deviation 0.83 |
| 15-minute App Usage | Change in Healthy Minds Index (HM Index): Purpose | T2 Post-Test Week 4 | 3.88 score on a scale | Standard Deviation 0.9 |
Secondary
Change in Meaning in Life Questionnaire (MLQ) Presence Subscale
MLQ Presence is a 5-item questionnaire assessing the presence of meaning in life. It is scored on a 1- to 7-point Likert scale where 1 = absolutely untrue and 7 = absolutely true. Mean scores are reported for a total range from 1 to 7 where higher scores indicate greater presence of meaning in life.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Meaning in Life Questionnaire (MLQ) Presence Subscale | T2 Post-test Week 4 | 4.27 score on a scale | Standard Deviation 1.36 |
| 5-minute App Usage | Change in Meaning in Life Questionnaire (MLQ) Presence Subscale | Change | 0.74 score on a scale | Standard Deviation 1.08 |
| 5-minute App Usage | Change in Meaning in Life Questionnaire (MLQ) Presence Subscale | T1 Baseline | 3.58 score on a scale | Standard Deviation 147 |
| 15-minute App Usage | Change in Meaning in Life Questionnaire (MLQ) Presence Subscale | T2 Post-test Week 4 | 4.53 score on a scale | Standard Deviation 1.31 |
| 15-minute App Usage | Change in Meaning in Life Questionnaire (MLQ) Presence Subscale | Change | 0.93 score on a scale | Standard Deviation 1.29 |
| 15-minute App Usage | Change in Meaning in Life Questionnaire (MLQ) Presence Subscale | T1 Baseline | 3.62 score on a scale | Standard Deviation 1.5 |
Secondary
Change in NIH Toolbox Loneliness
NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in NIH Toolbox Loneliness | T1 Baseline | 2.76 score on a scale | Standard Deviation 0.92 |
| 5-minute App Usage | Change in NIH Toolbox Loneliness | T2 Post-test Week 4 | 2.20 score on a scale | Standard Deviation 1.02 |
| 5-minute App Usage | Change in NIH Toolbox Loneliness | Change | -0.54 score on a scale | Standard Deviation 0.65 |
| 15-minute App Usage | Change in NIH Toolbox Loneliness | T1 Baseline | 2.82 score on a scale | Standard Deviation 1.01 |
| 15-minute App Usage | Change in NIH Toolbox Loneliness | T2 Post-test Week 4 | 2.11 score on a scale | Standard Deviation 0.87 |
| 15-minute App Usage | Change in NIH Toolbox Loneliness | Change | -0.75 score on a scale | Standard Deviation 0.99 |
Secondary
Change in PROMIS Sleep Disturbance
Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance.
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in PROMIS Sleep Disturbance | T1 Baseline | 55.56 T-score | Standard Deviation 7.04 |
| 5-minute App Usage | Change in PROMIS Sleep Disturbance | T2 Post-Test Week 4 | 50.23 T-score | Standard Deviation 8.7 |
| 5-minute App Usage | Change in PROMIS Sleep Disturbance | Change | -5.20 T-score | Standard Deviation 6.72 |
| 15-minute App Usage | Change in PROMIS Sleep Disturbance | T1 Baseline | 53.77 T-score | Standard Deviation 5.81 |
| 15-minute App Usage | Change in PROMIS Sleep Disturbance | T2 Post-Test Week 4 | 48.84 T-score | Standard Deviation 8.19 |
| 15-minute App Usage | Change in PROMIS Sleep Disturbance | Change | -5.04 T-score | Standard Deviation 9.31 |
Secondary
Change in Wellbeing Growth Mindset
Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable).
Time frame: Baseline, and post-test (week 4)
Population: 3 participants withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-minute App Usage | Change in Wellbeing Growth Mindset | T1 Baseline | 13.77 score on a scale | Standard Deviation 3.02 |
| 5-minute App Usage | Change in Wellbeing Growth Mindset | T2 Post-time Week 4 | 14.60 score on a scale | Standard Deviation 2.64 |
| 5-minute App Usage | Change in Wellbeing Growth Mindset | Change | 0.68 score on a scale | Standard Deviation 2.15 |
| 15-minute App Usage | Change in Wellbeing Growth Mindset | Change | 1.59 score on a scale | Standard Deviation 2.38 |
| 15-minute App Usage | Change in Wellbeing Growth Mindset | T1 Baseline | 13.48 score on a scale | Standard Deviation 2.99 |
| 15-minute App Usage | Change in Wellbeing Growth Mindset | T2 Post-time Week 4 | 15.11 score on a scale | Standard Deviation 2.63 |
Secondary
Count of Participant Responses to Adverse Event Relevant Survey Item
Participants were asked a single survey item to assess their meditation experience. The query was I had challenging, difficult, or distressing experiences as a result of my meditation during this study. Participants chose from the following responses: Never, Rarely, Occasionally, Regularly, or Frequently. Count of participants in each arm answering each response is reported here.
Time frame: up to 4 weeks
Population: 3 participants withdrew from the study prior to the post-test measure, 1 participant did not answer the question
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Rarely | 9 Participants |
| 5-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Regularly | 1 Participants |
| 5-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Occasionally | 4 Participants |
| 5-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Frequently | 0 Participants |
| 5-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Never | 30 Participants |
| 15-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Frequently | 1 Participants |
| 15-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Never | 33 Participants |
| 15-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Rarely | 5 Participants |
| 15-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Occasionally | 4 Participants |
| 15-minute App Usage | Count of Participant Responses to Adverse Event Relevant Survey Item | Regularly | 1 Participants |
Other Pre-specified
Change in EMA-assessed Connection With Others
A single item assessing connection with others is scored on a 1- to 5-point Likert scale where 1 = not often at all and 5 = extremely often
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Decentering
A single item assessing decentering (i.e., experiencing thoughts more as events than direct reflection of reality) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Informal Practice
A single item assessing application of meditation techniques in daily life (informal practice) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Insight
A single item assessing insight is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Loneliness
A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Mindfulness of Activities
A single item mindfulness of activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Mindfulness of Feelings / Emotions
A single item assessing awareness of feelings is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Personal Values / Meaning
A single item assessing reflection of personal values in current activity is scored on a 1- to 5-point Likert scale where 1 = not at all reflected and 5 = extremely reflected.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items)
A single item reflecting depression and a single item reflecting anxiety are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Purpose
A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Rumination
A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in EMA-assessed Stressor Exposure
A single item assessing stressor exposure is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
Time frame: 4 times per day from baseline to post-test (week 4)
Other Pre-specified
Change in Post-practice Focus
A single item assessing focus during meditation is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time
Time frame: Before and after meditation practices between baseline and post-test (week 4)
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
Time frame: Before and after meditation practices between baseline and post-test (week 4)
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.
Time frame: Before and after meditation practices between baseline and post-test (week 4)
Other Pre-specified
Digital Working Alliance Inventory (DWAI)
The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance.
Time frame: Post-test (week 4)