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

Stony Brook University

Status: Unknown

Conditions: Insomnia; Morbid Obesity

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT04619771

IRB2020-00283

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cognitive Behavioral Therapy for Insomnia

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia