Brief Behavioral Treatment for Sleep Problems in IBS Study

NCT03087799 | Completed

• 1 other identifier: 2016P000440
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Change in Irritable Bowel Syndrome Severity Scoring System

  A measure of IBS symptom severity

  5 weeks

Secondary Outcomes (2)

• Change in Insomnia Severity Index

  5 weeks

• Change in Pittsburgh Sleep Quality Index

  5 weeks

Study Arms (2)

Brief Behavioral Treatment for Sleep

EXPERIMENTAL

Behavioral: Brief Behavioral Treatment for Sleep

Wait List Control

NO INTERVENTION

Interventions

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.

Brief Behavioral Treatment for Sleep

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Parasomnias

Interventions

Sleep

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 23, 2017
• Study Start: March 3, 2017
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)