The Advancing Dynamic And Personalized Training Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,553
- 试验地点
- 1
- 主要终点
- Change in PHQ-9
研究概览
简要总结
This study aims to enhance the Healthy Minds Program (HMP) app by developing and testing a personalized, data-driven approach to optimize long-term well-being. 1100 participants will be enrolled and on study for up to 4 months (4 week intervention plus 3 month follow-up).
详细描述
Participants will be randomly assigned to various training conditions that vary across six factors. Each of the six factors is binary ("yes" vs. "no"), and for each factor there is a 50 percent probability of assignment to either level.
- Introduction video for the app (yes / no)
- Introduction video for the training modules (yes / no)
- Module order based on ACIP score (highest-first / lowest-first)
- Practice-nudging text messages (yes / no)
- Microsupport messages during the intervention period (yes / no)
- Microsupport messages during the follow-up period (yes / no)
Participants will take surveys at baseline, weekly through the 4-week intervention, and 3-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 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
- 是
入选标准
- •Elevated symptoms of depression (PHQ-9 greater than or equal to 5)
- •proficiency in English
- •access to a smartphone and internet
- •ability to receive text messages
排除标准
- •Prior experience with meditation
- •Prior use of the Healthy Minds Program app
- •History of psychosis or mania
- •Plans to travel in the next six weeks
- •Suicidal ideation or thoughts of self-harm indicated by PHQ-9 item 9 and BDI item 9
- •Failure to select the correct code word mentioned in the welcome video
- •Not a US citizen
- •Non-permanent resident
- •Self-identification as artificial intelligence (AI)
- •Has a hearing impairment
研究组 & 干预措施
Module Order based on ACIP Score
All participants are randomized to this condition (Highest score first or Lowest score first)
干预措施: Healthy Minds Program (HMP) app (Other)
Introduction Video to HMP app
All participants are randomized to this condition (Yes or No)
干预措施: Healthy Minds Program (HMP) app (Other)
Introduction Video to Training Modules
All participants are randomized to this condition (Yes or No)
干预措施: Healthy Minds Program (HMP) app (Other)
Practice-Nudging Test Messages
All participants are randomized to this condition (Yes or No)
干预措施: Healthy Minds Program (HMP) app (Other)
Microsupport Messages During Intervention
All participants are randomized to this condition (Yes or No)
干预措施: Healthy Minds Program (HMP) app (Other)
Microsupport Messages During Follow-Up
All participants are randomized to this condition (Yes or No)
干预措施: Healthy Minds Program (HMP) app (Other)
结局指标
主要结局
Change in PHQ-9
时间窗: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)
PHQ-9 is a 9 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 and 4=nearly every day. Scores range from 0-36, where higher scores indicate more depressive symptoms.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in PROMIS Anxiety Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Acceptability of Intervention Measure(week 4 (of intervention period))
- Change in Growth Mindset Scale for Well-Being(Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- HMP engagement measure(Week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Cannabis Use Disorder Identification Test - Revised (CUDIT-R)(Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Alcohol Use Disorders Identification Test (AUDIT)(Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Big Five Inventory-2 Extra Short Form (BFI-2-XS)(Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Mindfulness Adherence Questionnaire (MAQ)(Week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change PROMIS Sleep Disturbance Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Healthy Minds Index (HMI) Score(Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in PROMIS Global Health Score(Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Ruminative Response Scale (RSS) Score(Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Self-Compassion Scale - Short Form (SCS-SF)(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in PROMIS Meaning and Purpose Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Flourishing Index Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Digital Working Alliance Inventory (DWAI)(week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Decentering Subscale of Experiencing Questionnaire score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in NIH Toolbox Loneliness Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-Acting with Awareness) Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Five-facet Mindfulness Questionnaire: Non-reactivity Subscale (FFMQ-Non-reactivity) Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Change in Perceived Stress Scale (PSS) Score(Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study))
- Morning Daily Diary Items(Daily through the Intervention Period (up to 4 weeks))
- Evening Daily Diary Items(Daily through the Intervention Period (up to 4 weeks))
- Percentage of participants with a formal practice(Daily through the Intervention Period (up to 4 weeks))
- Percentage of participants with a informal practice(Daily through the Intervention Period (up to 4 weeks))
- Percentage of participants received a text message(Daily through the Intervention Period (up to 4 weeks))