Behavior, Biology and Well-Being Study

Study Overview
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Brief Summary
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The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation [HMP without meditation practice]), and a waitlist control in a sample of United States adults with elevated depression symptoms.

Detailed Description
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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.

Official Title
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Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression

Conditions
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Depression, Psychological Distress

Intervention / Treatment
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* Device: Healthy Minds Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The groups will be randomized to one of three groups in a 2:2:1 ratio.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Minds Program (HMP) app<br>Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. | Device: Healthy Minds Program<br>* HMP is a 4-week mobile health (mHealth) meditation training program.<br>* Other names: HMP;|
| Active Comparator: Psychoeducation app<br>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. | Device: Healthy Minds Program<br>* HMP is a 4-week mobile health (mHealth) meditation training program.<br>* Other names: HMP;|
| No Intervention: Usual Care<br>Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., my sleep was restful). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| 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. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score | The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| Change in Connection Measured by NIH Toolbox Loneliness Score | The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| Change in Decentering Measured by Decentering Subscale of Experiencing Questionnaire scale score | The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., I understand my life's meaning). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| Change in Pain Intensity measured by PROMIS Pain Intensity score | The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity | Baseline, week 4 (of intervention period), and 3 month follow-up | 
| Change in Pain Interference measured by PROMIS Pain Inference Scale Score | The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., how much did pain interfere with your enjoyment of life). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference. | Baseline, week 4 (of intervention period), and 3 month follow-up | 
| Change in Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up | 
| Change in Climate Change Anxiety Scale | The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., I have nightmares about climate change). It is scored on a 5-point Likert scale where 1 = never to 5 = almost always. Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety. | Baseline, week 4, and 3 month follow up | 
| Change in Wellbeing Growth Mindset | The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., Your well-being is something about you that you can't change very much.). It is scored on a 6-point Likert scale where 1 = strongly disagree to 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset. | Baseline, week 4, and 3 month follow up | 
| Change in Healthy Minds Index (HM Index) | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality. | Baseline, week 4, and 3 month follow up | 
| Change in Life Orientation Test - Revised | The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., In uncertain times, I usually expect the best). It is scored on a 5-point Likert scale where 0 = strongly disagree to 4 = strongly agree. Total scores range from 0 to 24 where higher scores indicate greater optimism. | Baseline, week 4, and 3 month follow up | 
| Change in Perceived Stress Scale | The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., In the last month, how often have you felt nervous and 'stressed'?). It is scored on a 5-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 40 where higher scores indicate greater perceived stress. | Baseline, week 4, and 3 month follow up | 
| Change in Perseverative Thinking Questionnaire | The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., My thoughts repeat themselves). It is scored on a 5-point Likert scale where 0 = never to 4 = almost always. Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking. | Baseline, week 4, and 3 month follow up | 
| Change in Satisfaction with Life Scale | The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., In most ways my life is close to ideal). It is scored on a 7-point Likert scale where 1 = strongly disagree to 7 = strongly agree. Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life. | Baseline, week 4, and 3 month follow up | 
| Change in Subjective Happiness Scale | The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., In general, I consider myself [not a very happy person, a very happy person]). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness. | Baseline, week 4, and 3 month follow up | 
| Change in Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use. | Baseline, week 4, and 3 month follow up |