COVID-19 and the Healthy Minds Program for Educators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 698
- 试验地点
- 1
- 主要终点
- Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
研究概览
简要总结
This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted.
Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted.
The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.
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
- Single (Investigator)
盲法说明
There is no outcome assessor - all assessments will be conducted online by participants. Investigators will be blind to group assignment during data analysis. Analysis of hypotheses related to baseline characteristics, adherence and dosage cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 years old and up
- •Employees of a K-12 school district in Wisconsin
- •Smartphone or device that can download apps from Google Play or the iTunes app store
排除标准
- •Individuals under 18 years old
- •Significant meditation experience:
- •Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component),
- •Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or
- •Previous use of the HMP app.
- •Patient-Reported Outcomes Measurement Information System (PROMIS) depression score > 70
研究组 & 干预措施
Healthy Minds Program Foundations Training
Healthy Minds Program (HMP) Description:
The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Richard Davidson, PhD. HMP is 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 high-quality 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). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
干预措施: Healthy Minds Program Foundations Training (Behavioral)
Wait-list control
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
结局指标
主要结局
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
时间窗: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.
次要结局
- Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale(baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the Drexel Defusion Scale (DDS)(baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the Meaning in Life Questionnaire(baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the NIH Toolbox Loneliness Scale(baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Conway COVID Questionnaire Subscale Scores(16 weeks (3 months post-intervention))
- Self-Compassion Scale Short Form Score(baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the Perseverative Thought Questionnaire(baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale(baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the Neutral Face Rating Task: Prosocial Construal(baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the Neutral Face Rating Task: Race Bias(baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention))
- Change From Baseline on the Growth Mindset Scale for Well-Being(baseline, 4 weeks (post intervention))
- Conway COVID Questionnaire Subscale Scores(baseline)
- Conway COVID Questionnaire Subscale Scores(4 weeks (post intervention))