Brief Behavioral Treatment for Sleep Problems in IBS Study

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087799
• Other study ID #: 2016P000440
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: August 8, 2019

Study information

• Verified date: March 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Irritable Bowel Syndrome
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Irritable Bowel Syndrome Severity Scoring System	A measure of IBS symptom severity	5 weeks
Secondary	Change in Insomnia Severity Index	A measure of insomnia	5 weeks
Secondary	Change in Pittsburgh Sleep Quality Index	A measure of sleep quality	5 weeks