Irritable Bowel Syndrome, Sleep Disturbance
Conditions
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.
Interventions
BEHAVIORALBrief 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.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Irritable Bowel Syndrome Severity Scoring System | 5 weeks | A measure of IBS symptom severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index | 5 weeks | A measure of insomnia |
| Change in Pittsburgh Sleep Quality Index | 5 weeks | A measure of sleep quality |
Countries
United States
Outcome results
None listed