Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Feasibility-Attendance
研究概览
简要总结
The goal of this clinical trial is to adapt a sleep intervention for individuals representative of all demographic groups, including those who are at the highest risk for suicidal behavior. Sleep difficulties are a promising target for youth with suicidal thoughts and behavior to focus on as a prevention measure. We aim to increase intervention acceptability and impact by adapting it for the adolescent populations at highest risk for suicidal thoughts and behavior. The research project will compare Transdiagnostic Sleep and Circadian Intervention (TranS-C), an evidence based, modularized intervention that targets a range of sleep difficulties to a treatment as usual or control condition including providing weekly sleep feedback reports from data entered into a daily sleep diary and from wearing a sleep sensing, actigraphy watch. Participants in both conditions (TranS-C vs. Sleep Feedback) will wear an actigraphy sleep watch that monitors sleep, and complete daily sleep diaries via smartphone or email. Participants in the TranS-C condition will also wear bright light (BL) and blue blocking glasses each day as well as attend weekly or biweekly sessions with a Sleep Therapist. The sleep therapist will review sleep feedback during sessions.
详细描述
This study will adapt TranS-C+BL for at-risk adolescents using health equity-informed implementation science methods.
This randomized trial will enroll 75 youth aged 12-18 at risk for STB and clinically significant sleep difficulties identified in primary care. The randomization that this study uses is a 2:1 allocation to compare TranS-C+BL Sleep Feedback vs. Sleep Feedback Alone.
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 (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
- •Adolescents (12-18)
- •Current moderate to severe depression as measured by the PHQ-9M with a total score of greater than or equal to 11
- •Current clinically significant sleep disturbance measured by the PHQ-9-M sleep item greater than or equal to
- •English language fluency and literacy sufficient to engage in study protocol.
排除标准
- •Evidence of obstructive sleep apnea,
- •Evidence of restless legs syndrome
- •Evidence of psychosis
- •Evidence of bipolar disorder
- •Evidence of a developmental disability precluding comprehension of study procedures per electronic health record and eligibility screening.
研究组 & 干预措施
Sleep Feedback
Participants receive an actigraphy watch to track their sleep and activity levels and complete a daily sleep diary; sleep feedback graphs show participants their actigraphy watch and sleep diary data on demand.
干预措施: Sleep Feedback (Behavioral)
TranS-C + Sleep Feedback
Participants will attend 6-8 TranS-C sessions with a Sleep therapist. Participants will also wear bright light glasses in the morning and blue light blocking glasses in the evening throughout the intervention.
干预措施: TranS-C (Behavioral)
TranS-C + Sleep Feedback
Participants will attend 6-8 TranS-C sessions with a Sleep therapist. Participants will also wear bright light glasses in the morning and blue light blocking glasses in the evening throughout the intervention.
干预措施: Sleep Feedback (Behavioral)
结局指标
主要结局
Feasibility-Attendance
时间窗: From enrollment to the end of the treatment (up to 4 months)
Feasibility of interventions as by measured by the mean of number of sessions attended. Local study documents are used to track each session that was completed.
Feasibility-Attrition
时间窗: From enrollment until withdrawal or completing treatment sessions.
Attrition will be assessed using a study-specific form reflecting participants who withdraw or are withdrawn from the TranS-C+ intervention. The proportion of patients who withdraw or are withdrawn will be calculated.
Acceptability-Treatment Satisfaction
时间窗: 4 month
Treatment satisfaction will be measured by the patient-reported Treatment Satisfaction Questionnaire administered post-treatment. The Treatment Satisfaction Questionnaire assesses satisfaction with the treatment received and perception of progress; each item is rated on a Likert scale. Additional open-ended questions allow for participants to share feedback on strengths and weaknesses as well as any other feedback related to their satisfaction with the intervention. The Questionnaire has questions on a 1(Not at all)-7(Very Much). Questions on study clinicians are asked on a 1(Poor)-7(Superior) Likert scale. Questions on the duration of study on a 1(Much too short)-7(Much to long) Likert scale. Questions about frequency of visits on a 1(Much too infrequent)-7(Much to frequent). Questions for recommendations to other rated on a 1(Strongly recommend)-7(Strongly not recommend). Questions on future outlook rated on a 1(Very Pessimistic)-7(Very Optimistic).
次要结局
- Sleep Disturbance(4 months)
- Depression(4 month)
- Risk for Suicidal Thoughts and Behaviors(4 month)
研究者
Tina R Goldstein
Professor
University of Pittsburgh