M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER) (MASTER)
2021年3月15日 更新者：Genna Popovich Hymowitz、Stony Brook University
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.
研究概览
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Genna F Popovich Hymowitz, Ph.D.
- 电话号码：631-632-8657
- 邮箱：genna.hymowitz@stonybrookmedicine.edu
研究联系人备份
- 姓名：Marshall Beauchamp, Ph.D.
- 电话号码：631-632-8657
- 邮箱：marshall.beauchamp@stonybrookmedicine.edu
学习地点
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New York
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Stony Brook、New York、美国、11794
- 招聘中
- Stony Brook University
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接触：
- Genna F P Hymowitz
- 电话号码：631-632-8657
- 邮箱：genna.hymowitz@stonybrookmedicine.edu
-
接触：
- Marshall P Beauchamp
- 电话号码：16316328657
- 邮箱：marshall.beauchamp@stonybrook.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cognitive Behavioral Therapy for Insomnia
CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT.
This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session.
We will deliver 5 CBT-I sessions over the course of 8 weeks.
Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping.
Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing.
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CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT.
This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session.
5 CBT-I sessions will be delivered over the course of 8 weeks.
Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping.
Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment Rate
大体时间：Follow Up (week 15)
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Number of participants screened into the study per month will help measure feasibility.
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Follow Up (week 15)
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Completion of Study Measures
大体时间：Follow Up (week 15)
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The average percentage of study measures (self-report questionnaires, daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility.
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Follow Up (week 15)
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ActiGraph Use
大体时间：Follow Up (week 15)
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The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
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Follow Up (week 15)
|
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Actigraph Compliance
大体时间：Follow Up (week 15)
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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.
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Follow Up (week 15)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment Acceptability
大体时间：Follow Up (week 15)
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Treatment Acceptability Questionnaire will measure acceptability with patient-reported treatment satisfaction, and open-ended questions about satisfaction with both CBT-I and telemedicine (e.g., "What did you think about treating sleep as part of your Bariatric care?"; "How did you feel about getting treatment without being face-to-face?";
"What could we do to improve your treatment experience?").
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Follow Up (week 15)
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Change in sleep onset latency
大体时间：Follow-up (week 15)
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Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
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Follow-up (week 15)
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Change in wake after sleep onset (WASO)
大体时间：Follow-up (week 15)
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Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
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Follow-up (week 15)
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Change in total sleep time (TST)
大体时间：Follow-up (week 15)
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Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
|
Follow-up (week 15)
|
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Change in sleep efficiency
大体时间：Follow-up (week 15)
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This will be measured by actigraph data and data from participant daily sleep logs.
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Follow-up (week 15)
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Change in Insomnia Severity
大体时间：Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15)
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The Insomnia Severity Index will be used to assess insomnia symptoms.
The total score ranges from 0 to 63, with higher scores indicating more severe insomnia symptoms.
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Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15)
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% Excess Weight Loss
大体时间：Baseline (week 1), Follow-up (week 15)
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Measured weight data will be extracted from electronic medical records.
The following formula will be used to calculate % excess weight loss.
%EWL = [(Initial Weight) - (Post Intervention Weight)] / [(Initial Weight) - (Ideal Weight)].
Ideal weight will be extracted from the EMR.
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Baseline (week 1), Follow-up (week 15)
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Change in BMI
大体时间：Baseline (week 1), Follow-up (week 15)
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BMI will be extracted from electronic medical records and the formula: ΔBMI = (Initial BMI) - (BMI at week 15) will be used to calculate change in BMI.
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Baseline (week 1), Follow-up (week 15)
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% Total Weight Loss
大体时间：Baseline (week 1), Follow-up (week 15)
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Weight data will be extracted from the electronic medical record.
%TWL will be calculated using the following formula: % TWL= [(Initial Weight) - (Post intervention Weight)] / [(Initial Weight)]× 100
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Baseline (week 1), Follow-up (week 15)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Genna F Popovich Hymowitz, Ph.D.、Stony Brook University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月1日
初级完成 (预期的)
2021年11月1日
研究完成 (预期的)
2022年2月1日
研究注册日期
首次提交
2020年10月27日
首先提交符合 QC 标准的
2020年11月2日
首次发布 (实际的)
2020年11月6日
研究记录更新
最后更新发布 (实际的)
2021年3月17日
上次提交的符合 QC 标准的更新
2021年3月15日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.