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Trial record 27 of 2192 for:    Symptoms | Parasomnias

Brief Behavioral Treatment for Sleep Problems in IBS Study

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ClinicalTrials.gov Identifier: NCT03087799
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Sleep Disturbance Behavioral: Brief Behavioral Treatment for Sleep Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Behavioral Treatment for Sleep Problems in Irritable Bowel Syndrome: a Pilot Study
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
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.

No Intervention: Wait List Control



Primary Outcome Measures :
  1. Change in Irritable Bowel Syndrome Severity Scoring System [ Time Frame: 5 weeks ]
    A measure of IBS symptom severity


Secondary Outcome Measures :
  1. Change in Insomnia Severity Index [ Time Frame: 5 weeks ]
    A measure of insomnia

  2. Change in Pittsburgh Sleep Quality Index [ Time Frame: 5 weeks ]
    A measure of sleep quality



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087799


Contacts
Contact: Sarah Ballou, Ph.D 617-667-0689 sballou@bidmc.harvard.edu
Contact: Vivian Cheng, M.S. 617-667-0682 vcheng2@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sarah Ballou, Ph.D.    617-667-0689    sballou@bidmc.harvard.edu   
Sub-Investigator: Sarah Ballou, Ph.D.         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03087799     History of Changes
Other Study ID Numbers: 2016P000440
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Signs and Symptoms
Syndrome
Irritable Bowel Syndrome
Dyssomnias
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations