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

NCT04619771 | Unknown

• 1 other identifier: IRB2020-00283
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Morbid Obesity

Keywords

Insomnia; Sleep; Bariatric Surgery; Morbid Obesity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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 sleep efficiency

  Follow-up (week 15)

Study Arms (1)

Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

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

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Also known as: CBT-I

Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stony Brook University: lead
• Johns Hopkins University: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Obesity, Morbid

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Genna F Popovich Hymowitz, Ph.D.

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Genna F Popovich Hymowitz, Ph.D.

CONTACT

631-632-8657; genna.hymowitz@stonybrookmedicine.edu

Marshall Beauchamp, Ph.D.

CONTACT

631-632-8657; marshall.beauchamp@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 6, 2020
• Study Start: January 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)