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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Morbid Obesity
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Genna F Popovich Hymowitz, Ph.D.; Phone Number: 631-632-8657; Email: genna.hymowitz@stonybrookmedicine.edu
• Study Contact Backup: Name: Marshall Beauchamp, Ph.D.; Phone Number: 631-632-8657; Email: marshall.beauchamp@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University
      • Contact: Genna F P Hymowitz; Phone Number: 631-632-8657; Email: genna.hymowitz@stonybrookmedicine.edu
      • Contact: Marshall P Beauchamp; Phone Number: 16316328657; Email: marshall.beauchamp@stonybrook.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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. 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.; Other Names: CBT-I

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Johns Hopkins University; Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Genna F Popovich Hymowitz, Ph.D., Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Morbid Obesity; Sleep; Insomnia; Bariatric Surgery
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Sleep Initiation and Maintenance Disorders; Obesity, Morbid
• Other Study ID Numbers: IRB2020-00283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No