Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,157
- 试验地点
- 1
- 主要终点
- Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
研究概览
简要总结
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.
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 meditation 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.
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
- •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
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
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: Healthy Minds Program (Device)
结局指标
主要结局
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
时间窗: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
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.
次要结局
- Healthy Minds Index (HM Index) - Insight(Baseline, week 4, and 3 month follow up)
- Life Orientation Test - Revised(Baseline, week 4, and 3 month follow up)
- Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Climate Change Anxiety Scale(Baseline, week 4, and 3 month follow up)
- Wellbeing Growth Mindset(Baseline, week 4, and 3 month follow up)
- Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Flourishing Measured by the Flourishing Index Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Connection Measured by NIH Toolbox Loneliness Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Pain Intensity Measured by PROMIS Pain Intensity Score(Baseline, week 4 (of intervention period), and 3 month follow-up)
- Pain Interference Measured by PROMIS Pain Inference Scale Score(Baseline, week 4 (of intervention period), and 3 month follow-up)
- Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up)
- Healthy Minds Index (HM Index) - Purpose(Baseline, week 4, and 3 month follow up)
- Healthy Minds Index (HM Index) - Awareness(Baseline, week 4, and 3 month follow up)
- Subjective Happiness Scale(Baseline, week 4, and 3 month follow up)
- Healthy Minds Index (HM Index) - Connection(Baseline, week 4, and 3 month follow up)
- Perceived Stress Scale(Baseline, week 4, and 3 month follow up)
- Perseverative Thinking Questionnaire(Baseline, week 4, and 3 month follow up)
- Satisfaction With Life Scale(Baseline, week 4, and 3 month follow up)
- Problematic and Risky Internet Use Screening Scale (PRIUSS-3)(Baseline, week 4, and 3 month follow up)