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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-02-28

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.

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Detailed Description

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Conditions

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Insomnia Morbid Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT-I

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No