Clinical trial NCT05183867: Behavior, Biology and Well-Being Study
Official title: Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Psychological Distress
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Hope for Depression Research Foundation
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-01-11
Enrollment: 1170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The groups will be randomized to one of three groups in a 2:2:1 ratio.
Primary purpose: TREATMENT

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

Detailed description: Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary outcomes:
measure: Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Flourishing Measured by the Flourishing Index Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Connection Measured by NIH Toolbox Loneliness Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Decentering Measured by Decentering Subscale of Experiencing Questionnaire scale score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Pain Intensity measured by PROMIS Pain Intensity score
timeFrame: Baseline, week 4 (of intervention period), and 3 month follow-up
measure: Change in Pain Interference measured by PROMIS Pain Inference Scale Score
timeFrame: Baseline, week 4 (of intervention period), and 3 month follow-up
measure: Change in Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Climate Change Anxiety Scale
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Wellbeing Growth Mindset
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Healthy Minds Index (HM Index)
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Life Orientation Test - Revised
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Perceived Stress Scale
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Perseverative Thinking Questionnaire
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Satisfaction with Life Scale
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Subjective Happiness Scale
timeFrame: Baseline, week 4, and 3 month follow up
measure: Change in Problematic and Risky Internet Use Screening Scale (PRIUSS-3)
timeFrame: Baseline, week 4, and 3 month follow up
Other outcomes:
measure: Change in Inflammatory Biomarkers
timeFrame: Baseline and 3 month follow-up
measure: Change in Microbiome Alpha Diversity
timeFrame: Baseline and 3 month follow-up
measure: Change in Facial Behavior
timeFrame: Baseline, week 4 (of intervention period), and 3 month follow-up
measure: Change in Pattern Separation Task
timeFrame: Baseline, week 4 (of intervention period), and 3 month follow-up
measure: Change in Self-Referential Pronoun Use
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Negative Affect Word Use
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
measure: Change in Digital Working Alliance Inventory
timeFrame: week 1, week 2, week 3, week 4, and 3-month follow-up
measure: Change in Inclusion of Nature in Self
timeFrame: Baseline, week 4 (of intervention period), and 3 month follow-up
measure: Mindfulness Adherence Questionnaire
timeFrame: week 1, week 2, week 3, week 4, and 3 month follow up
measure: Change in pre- and post-practice positive affect
timeFrame: Before and after HMP activities between baseline and post-test (week 4)
measure: Change in pre- and post-practice negative affect
timeFrame: Before and after HMP activities between baseline and post-test (week 4)
measure: Change in post-practice focus
timeFrame: Before and after Before and after HMP activities between baseline and post-test (week 4)
measure: Treatment Expectancies
timeFrame: week 4
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW-Madison, Center for Healthy Minds
name: Simon Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: