Brief Behavioral Treatment for Sleep Problems in IBS Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome, Sleep Disturbance

Intervention / Treatment
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* Behavioral: Brief Behavioral Treatment for Sleep


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Behavioral Treatment for Sleep<br> | Behavioral: Brief Behavioral Treatment for Sleep<br>* 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.<br>|
| No Intervention: Wait List Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Irritable Bowel Syndrome Severity Scoring System | A measure of IBS symptom severity | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | A measure of insomnia | 5 weeks | 
| Change in Pittsburgh Sleep Quality Index | A measure of sleep quality | 5 weeks |