- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03087799
Brief Behavioral Treatment for Sleep Problems in IBS Study
March 3, 2020 updated by: Anthony Lembo, Beth Israel Deaconess Medical Center
Brief Behavioral Treatment for Sleep Problems in Irritable Bowel Syndrome: a Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait List Control
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Experimental: Brief Behavioral Treatment for Sleep
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Irritable Bowel Syndrome Severity Scoring System
Time Frame: 5 weeks
|
A measure of IBS symptom severity
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insomnia Severity Index
Time Frame: 5 weeks
|
A measure of insomnia
|
5 weeks
|
Change in Pittsburgh Sleep Quality Index
Time Frame: 5 weeks
|
A measure of sleep quality
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2017
Primary Completion (Actual)
August 8, 2019
Study Completion (Actual)
August 8, 2019
Study Registration Dates
First Submitted
March 2, 2017
First Submitted That Met QC Criteria
March 17, 2017
First Posted (Actual)
March 23, 2017
Study Record Updates
Last Update Posted (Actual)
March 4, 2020
Last Update Submitted That Met QC Criteria
March 3, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P000440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
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University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
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University of ViennaCompleted
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Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
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Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
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Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on Brief Behavioral Treatment for Sleep
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Ohio State UniversityUnknownDepression | Heart Failure | Sleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Anxiety | Congestive Heart Failure | Cardiac Failure | Disorders of Initiating and Maintaining SleepUnited States
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National Cheng-Kung University HospitalRecruitingOlder Adults | Chronic Insomnia | Sleep HygieneTaiwan
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University of North Carolina, Chapel HillCompleted
-
VA Pittsburgh Healthcare SystemCompletedInsomnia | Treatment Resistant DepressionUnited States
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University of PittsburghNational Institute of Mental Health (NIMH)CompletedChronic InsomniaUnited States
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Brigham and Women's HospitalRecruiting
-
VA Pittsburgh Healthcare SystemVA Office of Research and DevelopmentCompleted
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State University of New York at BuffaloNational Institute of Nursing Research (NINR); Roswell Park Cancer InstituteCompleted
-
Lovisenberg Diakonale HospitalOslo Metropolitan UniversityCompleted
-
VA Office of Research and DevelopmentUniversity of California, San FranciscoCompleted