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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

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
Experimental: Brief Behavioral Treatment for Sleep
Behavioral: Brief 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.

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.

Sponsor

Beth Israel Deaconess Medical Center

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.

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