Massed and Spaced Healthy Minds Program App Dosage Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 2
- 主要终点
- Percentage of participants who completed the study
研究概览
简要总结
This study is a randomized controlled trial (RCT) of 2 weeks of the Healthy Minds Program (HMP) app Connection module in undergraduate students of a large, midwestern state university in the United States during the spring of 2021.
Participants will be recruited via email and/or flyers and will first complete an online screen. Eligible participants will complete baseline measures prior to attending an introductory session via web conferencing. During this session, participants will be randomly assigned to condition. Participants in both conditions will be asked to use the HMP app for 20 minutes per either, either split over two 10-minute session (Spaced condition) or in one 20-minute session (Massed condition). Participants will complete daily survey measures during the study and post-test measures after 2 weeks of intervention.
This study is primarily designed to assess feasibility and acceptability of 2 weeks of Connection training and assignment to dosage condition. Study team will investigate self-reported informal practice on the daily diary measure, measures of psychological distress (composite of depression, anxiety) and loneliness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •18 years or older
- •Undergraduate at UW-Madison
- •Access to a smartphone or device capable of downloading HMP app
- •PROMIS Depression or PROMIS Anxiety ≥55
排除标准
- •Meditation retreat experience
- •Regular meditation practice (i.e., weekly practice for >1 year OR daily practice within previous 6 months)
- •Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
- •PROMIS Depression ≥70
结局指标
主要结局
Percentage of participants who completed the study
时间窗: 2 weeks
Number of meditation sessions per day using the HMP app
时间窗: 2 weeks
Number of minutes of meditation practice using the HMP app
时间窗: 2 weeks
System Usability Scale score
时间窗: 2 weeks
System usability scale is (SUS) is a 10-item Likert scale questionnaire that provides information on the ease of use (or lack thereof) of websites, software, hardware, mobile devices, and other technological applications. Higher SUS score correlates to better usability of an app, total score range = 0 to 100
次要结局
- Highest loading PROMIS Depression and PROMIS Anxiety items score(Up to 2 weeks)
- Change in Acceptance and Action Questionnaire - II score(Baseline and 2 weeks)
- Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score(Baseline and 2 weeks)
- Change in NIH Toolbox Loneliness score(Baseline and 2 weeks)
- Single item loneliness score(Up to 2 weeks)
- Single item informal meditation practice(Up to 2 weeks)
- Change in the PROMIS Anxiety score(Baseline and 2 weeks)
- Change in Fear of Missing Out scale score(Baseline and 2 weeks)
- Digital Working Alliance Inventory score(2 weeks)
- Change in Self-Compassion Short Form score(Baseline and 2 weeks)