Clinical trial NCT06213701: Behavior, Biology and Well-Being Study
Official title: Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Psychological Distress
Keywords: inflammation
microbiota
alpha diversity
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: 2024-01-19
Enrollment: 300
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 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.

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: Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
timeFrame: Baseline and 3 month follow-up
measure: Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
timeFrame: Baseline and 3 month follow-up
Secondary outcomes:
measure: Change in Microbiome Alpha Diversity: Species Richness
timeFrame: Baseline and 3 month follow-up
measure: Change in Microbiome Alpha Diversity: Shannon Diversity Index (H')
timeFrame: Baseline and 3 month follow-up
measure: Change in Microbiome Alpha Diversity: Inverse Simpson (1/D)
timeFrame: Baseline and 3 month follow-up
measure: Change in Microbiome Alpha Diversity: Pielou Evenness Index (J)
timeFrame: Baseline and 3 month follow-up
measure: Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D)
timeFrame: Baseline and 3 month follow-up
measure: Change in Inflammatory Biomarkers: C-reactive Protein
timeFrame: Baseline and 3 month follow-up
measure: Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
timeFrame: Baseline and 3 month follow-up
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
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
Other outcomes:
measure: Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
timeFrame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
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: