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Completed

NCT Number: NCT03087799

Brief Behavioral Treatment for Sleep Problems in IBS 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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Behavioral Treatment for Sleep

Behavioral

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 outcomes

  1. Change in Irritable Bowel Syndrome Severity Scoring System

    Time frame: 5 weeks

    A measure of IBS symptom severity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2017
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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