NCT04619771

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-11-01
• Completion: 2022-02-01
• First posted: 2020-11-06
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States