Brief Behavioral Treatment for Sleep Problems in IBS Study
Primary Purpose
Irritable Bowel Syndrome, Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Behavioral Treatment for Sleep
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief Behavioral Treatment for Sleep
Wait List Control
Arm Description
Outcomes
Primary Outcome Measures
Change in Irritable Bowel Syndrome Severity Scoring System
A measure of IBS symptom severity
Secondary Outcome Measures
Change in Insomnia Severity Index
A measure of insomnia
Change in Pittsburgh Sleep Quality Index
A measure of sleep quality
Full Information
NCT ID
NCT03087799
First Posted
March 2, 2017
Last Updated
March 3, 2020
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03087799
Brief Title
Brief Behavioral Treatment for Sleep Problems in IBS Study
Official Title
Brief Behavioral Treatment for Sleep Problems in Irritable Bowel Syndrome: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Sleep Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Behavioral Treatment for Sleep
Arm Type
Experimental
Arm Title
Wait List Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Treatment for Sleep
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Irritable Bowel Syndrome Severity Scoring System
Description
A measure of IBS symptom severity
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
A measure of insomnia
Time Frame
5 weeks
Title
Change in Pittsburgh Sleep Quality Index
Description
A measure of sleep quality
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brief Behavioral Treatment for Sleep Problems in IBS Study
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