Brief Behavioral Treatment for Sleep Problems in IBS Study

NCT ID: NCT03087799

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2019-08-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brief Behavioral Treatment for Sleep

Group Type: EXPERIMENTAL

Brief Behavioral Treatment for Sleep

Intervention Type: 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.

Wait List Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Anthony Lembo

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2016P000440

Identifier Type: -

Identifier Source: org_study_id