Smartphone-based Meditation Training to Reduce Adolescent Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PROMIS Pediatric Depression T-Scores
研究概览
简要总结
This study is being done to see if the Healthy Minds Program app helps adolescents with elevated depressive symptoms. Up to 200 participants will be on study for 20 weeks.
详细描述
Participants will be randomized into one of two groups: Healthy Minds Program intervention group (HMP) or a water tracking active control group. The groups will use different mobile health apps for eight weeks. All participants will complete assessments pre-intervention, after weeks 2, 4, and 6 of the intervention, at week 8 (post-intervention), and at week 20 (follow-up). Participants will complete a short daily diary set of questions on their social interactions that day. Participants will wear a Biostrap band for continuous collection of heart rate, movement, and daily sleep indices, and geolocation data will be extracted from participant phones using the FollowMee app. Participants will receive access to the app they were not assigned to after follow-up.
Primary Objective
- Assess acceptability and preliminary efficacy of an 8-week mHealth meditation training program on depressive symptoms.
Secondary Objectives
- Investigate effects of the meditation training program on symptoms of anxiety, behavior (social isolation), psychophysiological processes related to health and disease (e.g., sleep). Test changes in behavior and psychophysiology as mechanisms of improved mental health. Test whether improved mental health is associated with improved academic 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 to 19
- •Currently in high school (i.e., 9th to 12th grade) or if not attending school, would be in high school if enrolled
- •Proficient in English
- •Able to understand and provide informed consent (greater than or equal to 18 years old) or assent and parent/guardian consent (if less than 18 years old)
- •PROMIS Depression Scale T-score greater than or equal to 60
- •If on a psychotropic meditation, has been receiving a stable dose for greater than or equal to 4 weeks
- •Willing and able to complete all study procedures
排除标准
- •Has received a high school diploma or a high school equivalency diploma (HSED or GED)
- •Weekly or more frequent meditation practice
- •Prior use of the Healthy Minds Program app
- •Prior use of the water tracking app
- •Endorses current active suicidal ideation with intent on the baseline screen
- •Self-reported history of psychosis or mania
- •Practiced the techniques learned in a mindfulness-based therapy Acceptance Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), Mindfulness-Based Stress Reduction (MBSR) etc. one or more times per week in the last 6 months. Include therapy sessions if mindfulness is practiced in session or planning to start one of these therapies during the study period.
研究组 & 干预措施
Healthy Minds Program (HMP) App
The HMP is a smartphone meditation-based well-being training.
干预措施: Healthy Minds Program App (Other)
Hydro Coach active control group (HC)
The water tracking app is a publicly available, user-designed hydration app that prompts users to enter in daily liquid consumption and provides optimized hydration recommendations based on user input.
干预措施: Hydro Coach App (Other)
结局指标
主要结局
PROMIS Pediatric Depression T-Scores
时间窗: 8 weeks, 20 weeks
Efficacy will be measured with the PROMIS Pediatric Item Bank (version 3.0) Depressive Symptoms Short Form 8a survey which results in T-scores where a score of less than 55 = None to slight depression, 55.0-59.9 = Mild depression, 60.0-69.9 = Moderate depression, 70 and over = Severe depression.
次要结局
- PROMIS Pediatric Anxiety T-Scores(8 weeks, 20 weeks)
- EPOCH Wellbeing Scores(8 weeks, 20 weeks)
- PROMIS Pediatric Sleep Disturbance T-Score(8 weeks, 20 weeks)
- Sleep Duration assessed with wearable device(Daily through 20 weeks)
- Sleep Staging assessed with wearable device(Daily through 20 weeks)
- Wake after sleep onset(Daily through 20 weeks)
- Pulse Rate Variability (PRV) collected by a wearable sensor(Daily through 20 weeks)
- Belonging Uncertainty Scale Score(8 weeks, 20 weeks)
- Drexel Defusion Teen Score(8 weeks, 20 weeks)
- NIH Toolbox - Emotional Battery Loneliness (Ages 8-17) Fixed Form(8 weeks, 20 weeks)
- Perseverative Thinking Questionnaire - Child Scores(8 weeks, 20 weeks)
- Healthy Minds Index(8 weeks)
- Five Facet Mindfulness Questionnaire 16-item Adolescent version(8 weeks)
- Attitudes Towards Online Psychological Interventions(8 weeks)
- Adverse Meditation Experience Questionnaire(8 weeks, 20 weeks)