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

Not Applicable

• Conditions: Insomnia; Morbid Obesity
• Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT04619771
• Lead Sponsor: Stony Brook University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Study Start: 2021-01-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-11
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy for Insomnia	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.

Primary Outcome Measures

Name	Time	Method
ActiGraph Use	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	Follow Up (week 15)	Number of participants screened into the study per month will help measure feasibility.
Completion of Study Measures	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States