Brief Behavioral Treatment for Sleep Problems in IBS Study

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Sleep Disturbance
• Interventions: Behavioral: Brief Behavioral Treatment for Sleep

• Registration Number: NCT03087799
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-02
• Study Start: 2017-03-03
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-23
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age 20-50
• Meet diagnostic criteria for IBS
• Stable medication for IBS for at least 1 month
• Stable medication for sleep for at least 1 month
• ISI cutoff score of 10 or higher
• Completes at least 5 out of 7 days of daily symptom and sleep diary during 1 week baseline

Exclusion Criteria

• Medical history of significant head injury or other neurological disorder
• Pregnancy (self-reported)
• Post-menopause
• Major concomitant medical conditions
• Major psychiatric diagnosis with comorbid sleep problems
• Taking medications that might interfere with sleep
• Confirmed or suspected other untreated sleep disorder
• Active illicit drug use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Behavioral Treatment for Sleep	Brief Behavioral Treatment for Sleep	-

Primary Outcome Measures

Name	Time	Method
Change in Irritable Bowel Syndrome Severity Scoring System	5 weeks	A measure of IBS symptom severity

Secondary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index	5 weeks	A measure of sleep quality
Change in Insomnia Severity Index	5 weeks	A measure of insomnia

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States