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Brief Behavioral Treatment for Sleep Problems in IBS Study

NCT03087799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-03-04

No results posted yet for this study

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

  • Sleep Disturbance
  • Irritable Bowel Syndrome

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2019-08-08
Completion
2019-08-08

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087799 on ClinicalTrials.gov