M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)

Study Overview
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Brief Summary
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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.

Official Title
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M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)

Conditions
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Insomnia, Morbid Obesity

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy for Insomnia<br>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. | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* 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.<br>* Other names: CBT-I;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Number of participants screened into the study per month will help measure feasibility. | Follow Up (week 15) | 
| Completion of Study Measures | The average percentage of study measures (self-report questionnaires, daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility. | Follow Up (week 15) | 
| ActiGraph Use | The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility. | Follow Up (week 15) | 
| Actigraph Compliance | 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. | Follow Up (week 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Acceptability | 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?). | Follow Up (week 15) | 
| Change in sleep onset latency | Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. | Follow-up (week 15) | 
| Change in wake after sleep onset (WASO) | Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. | Follow-up (week 15) | 
| Change in total sleep time (TST) | Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. | Follow-up (week 15) | 
| Change in sleep efficiency | This will be measured by actigraph data and data from participant daily sleep logs. | Follow-up (week 15) | 
| Change in Insomnia Severity | 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. | Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15) | 
| % Excess Weight Loss | 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. | Baseline (week 1), Follow-up (week 15) | 
| Change in BMI | 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. | Baseline (week 1), Follow-up (week 15) | 
| % Total Weight Loss | 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 | Baseline (week 1), Follow-up (week 15) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Insomnia, Sleep, Bariatric Surgery