A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )
研究概览
简要总结
The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence
- •severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer)
- •current use of medications or herbs with known effects on sleep
- •plan to undergo or have had medication change in the last 8 weeks
研究组 & 干预措施
Psychoeducation
干预措施: Psychoeducation (Behavioral)
TranS-C
干预措施: TranS-C (Behavioral)
结局指标
主要结局
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )
时间窗: baseline to end of treatment (0 and 2 months)
Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior
Change in Children's Depression Rating Scale (CDRS-R)
时间窗: baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14
Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity
次要结局
未报告次要终点
研究者
Lauren Asarnow
Medical Staff/USC Faculty CWR Neurology
Children's Hospital Los Angeles