Brief Behavioral Treatment for Sleep Problems in IBS Study
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
25 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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