M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- ActiGraph Use
研究概览
简要总结
This study is a longitudinal clinical trial designed to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with insomnia following bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64
- •Fluency with English
- •Willingness to maintain an active telehealth platform account
- •Daily access to wireless internet connection or sufficient cell phone service for telemedicine
- •Undergone bariatric surgery (Roux-en-Y or vertical sleeve gastrectomy) within past 1-3 years
- •Must have experienced <50% excess weight loss following surgery Clinically significant insomnia (i.e., ISI score >11)
排除标准
- •Patient underwent revision of initial weight loss procedure
- •PHQ-9 Depression score > 15
- •GAD-7 Anxiety score > 15
- •Current alcohol or substance abuse
- •Current narcotic use
- •Unstable major psychiatric condition
- •Restless leg syndrome
- •Sleep apnea with non-adherence to CPAP intervention (i.e., use of CPAP <4 nights/week)
- •Other problems at investigator discretion
- •Vulnerable populations (e.g., adults unable to consent, ages <18, pregnant women, and prisoners).
结局指标
主要结局
ActiGraph Use
时间窗: Follow Up (week 15)
The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
Recruitment Rate
时间窗: Follow Up (week 15)
Number of participants screened into the study per month will help measure feasibility.
Completion of Study Measures
时间窗: Follow Up (week 15)
The average percentage of study measures (self-report questionnaires, daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility.
Actigraph Compliance
时间窗: Follow Up (week 15)
The average percentage of hours of wear per day of the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
次要结局
- Treatment Acceptability(Follow Up (week 15))
- Change in sleep onset latency(Follow-up (week 15))
- Change in wake after sleep onset (WASO)(Follow-up (week 15))
- Change in total sleep time (TST)(Follow-up (week 15))
- Change in Insomnia Severity(Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15))
- Change in BMI(Baseline (week 1), Follow-up (week 15))
- % Total Weight Loss(Baseline (week 1), Follow-up (week 15))
- Change in sleep efficiency(Follow-up (week 15))
- % Excess Weight Loss(Baseline (week 1), Follow-up (week 15))
研究者
Genna Popovich Hymowitz
Clinical Assistant Professor
Stony Brook University