NCT03087799

Brief Behavioral Treatment for Sleep Problems in IBS Study

Brief Behavioral Treatment for Sleep Problems in Irritable Bowel Syndrome: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4 weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of the current project is to assess feasibility of administering BBT-I to a sample of patients with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI population, this project will provide information about treatment adherence, recruitment, and effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS symptom severity.

Conditions

• Irritable Bowel Syndrome
• Sleep Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	Brief Behavioral Treatment for Sleep	The BBT arm will consist of 2 in-person treatment visits and 2 telephone check-in visits. Treatment will involve psychoeducation about sleep hygiene and stimulus control as well as sleep schedule modification and sleep restriction. The treatment manual is attached for clarification. This manual is used solely to guide clinical decision making and will not be provided to participants.

Timeline

• Start date: 2017-03-03
• Primary completion: 2019-08-08
• Completion: 2019-08-08
• First posted: 2017-03-23
• Last updated: 2020-03-04

Locations

1 site across 1 country: United States