Behavior, Biology and Well-Being Study
Condition: Depression; Psychological Distress
MeSH terms: Depression
Study type: Interventional

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.
    

Intervention name(s): Healthy Minds Program; Psychoeducation app
Intervention type(s): Device; Other
Intervention description(s): HMP is a 4-week mobile health (mHealth) meditation training program.; Psychoeducation app
Other intervention name(s): HMP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The groups will be randomized to one of three groups in a 2:2:1 ratio.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inflammation; microbiota; alpha diversity