Brief Behavioral Treatment for Sleep Problems in IBS Study

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome, Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT03087799

Run by

Beth Israel Deaconess Medical Center

People needed

25

Starts

2017-03-03

Expected to finish

2019-08-08

Last updated by the study team

2020-03-04

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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