Healthy Minds Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 1
- 主要终点
- Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety
研究概览
简要总结
The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.
Participants will complete an online four-week well-being program and complete surveys sent to their email. Participants can expect to participate in the study for four months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Elevated symptoms of depression and anxiety
- •Proficient in English
- •Access to a smartphone
排除标准
- •Prior experience with meditation generally
- •Prior use of the Healthy Minds application
- •History of psychosis or mania
- •Alcohol and/or substance use disorder
研究组 & 干预措施
Healthy Minds Program (HMP) - Awareness first
Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Awareness module first.
干预措施: HMP app (Behavioral)
Healthy Minds Research Platform (HMRP) - Awareness first
Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Awareness module first.
干预措施: HMRP web app (Behavioral)
HMP - Connection first
Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Connection module first.
干预措施: HMP app (Behavioral)
HMRP - Connection first
Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Connection module first.
干预措施: HMRP web app (Behavioral)
结局指标
主要结局
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety
时间窗: Baseline, weeks 1, 2, 3, 4, and 3 months
Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.
次要结局
- HMP App Utilization: Minutes(Study duration (4 weeks))
- Change in Digital Working Alliance Inventory (DWAI)(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Healthy Minds Index (HM Index): Awareness(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Wellbeing Growth Mindset(Baseline, weeks 1, 2, 3, 4, and 3 months)
- HMP App Utilization: Days(Study duration (4 weeks))
- Change in Healthy Minds Index (HM Index): Insight(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Experiences Questionnaire (EQ) Decentering Subscale(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Healthy Minds Index (HM Index): Purpose(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Perceived Stress Scale (PSS-10)(Baseline, weeks 1, 2, 3, 4, and 3 months)
- HMP App Utilization: Number of Activities(Study duration (4 weeks))
- Change in Subjective Happiness Scale(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Flourishing Measure(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in NIH Toolbox Loneliness(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Healthy Minds Index (HM Index): Connection(Baseline, weeks 1, 2, 3, 4, and 3 months)
- Change in Satisfaction with Life Scale (SWLS)(Baseline, weeks 1, 2, 3, 4, and 3 months)