Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •any current psychiatric illness
- •currently use of medications or herbs with known effects on sleep
- •hospitalization for substance use or suicide within the past 12 months
- •known sleep apnea
- •unstable major medical conditions
- •current psychotherapy for depression, anxiety or sleep health deficits
研究组 & 干预措施
mTranS-C
Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
干预措施: mTranS-C (Behavioral)
Control
Access to a mobile and computer accessible control intervention that targets coping skills and sleep education.
干预措施: Control (Behavioral)
结局指标
主要结局
Change in Pittsburgh Sleep Quality Index (PSQI)
时间窗: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
次要结局
- Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)(baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8)
- Change in cortisol reactivity and recovery in response to a stress exposure(baseline and at month 3)
- Change in the SCARED (Screen for Child Anxiety Related Disorders) total score(baseline, and at months 1, 2, 3 and 8)