Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Healthy Minds Program (HMP) app
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.
干预措施: Healthy Minds Program (Device)
Psychoeducation app
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.
干预措施: Psychoeducation app (Other)
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
结局指标
主要结局
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
时间窗: Baseline and 3 month follow-up
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
时间窗: Baseline and 3 month follow-up
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
次要结局
- Change in Microbiome Alpha Diversity: Species Richness(Baseline and 3 month follow-up)
- Change in Microbiome Alpha Diversity: Shannon Diversity Index (H')(Baseline and 3 month follow-up)
- Change in Microbiome Alpha Diversity: Inverse Simpson (1/D)(Baseline and 3 month follow-up)
- Change in Microbiome Alpha Diversity: Pielou Evenness Index (J)(Baseline and 3 month follow-up)
- Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D)(Baseline and 3 month follow-up)
- Change in Inflammatory Biomarkers: C-reactive Protein(Baseline and 3 month follow-up)
- Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10(Baseline and 3 month follow-up)
- Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score(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(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)