A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome
November 23, 2016 updated by: University of California, Los Angeles
A Six-Month Study to Compare Outcome Differences and Visceral Response in Subjects Randomized to a Psychological Intervention for Irritable Bowel Syndrome
The purpose of this study is to assess the effect of participation in one of the following interventions: (1) IBS Stress Management; (2) IBS Symptom Management; or (3) IBS Educational Training on improving IBS associated symptoms.
It is anticipated that this research will provide information on the usefulness of psychological approaches in treating IBS and will help scientists better understand the disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
163
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Irritable Bowel Syndrome
Exclusion Criteria:
- GI pathology (organic disease) that affects bowel transit
- Co-morbid pain disorders
- Current or recent history (within 24 months) of drug or alcohol abuse
- Clinical evidence (including physical exam, laboratory tests) of significant medical disease that may interfere with the patient successfully completing the trial
- Planned use of drugs or agents that affect GI motility and/or perception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
IBS Stress Management
|
If randomly assigned to this intervention, the session with the therapist will consist of training about IBS symptoms and their relationship to stress, as well as skills training in relaxation and ways of identifying and challenging mistaken thoughts about life events.
The goal of this treatment is to lessen mental and physical stressful reactions to daily events, and therefore lessen IBS symptoms as a reaction to stress.
The patient will be encouraged to apply relaxation skills to stressful situations.
|
|
Active Comparator: 2
IBS Symptom Management
|
If assigned to this group, the therapist will discuss feelings, over-attention to IBS symptoms, and your fear of IBS symptoms.
Patients will learn how to identify thoughts that may increase your IBS symptoms and will practice how to change these thoughts to ones that make them feel more comfortable.
The sessions will focus on reactions to daily life that in turn result in IBS Symptoms.
|
|
Active Comparator: 3
IBS Educational Training
|
Those assigned to this group will be given educational materials about IBS and will discuss the reading material with the therapist.
The reading topics include information on gut disorders, anatomy and physiology of the gut, assessment procedures, and how to manage IBS symptoms.
Sessions will also consist of weekly reviews of daily records and IBS symptoms.
The goal of this intervention is to provide educational training about IBS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in Symptoms
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
IBS-specific Quality of Life increase
Time Frame: 14 days
|
14 days
|
|
IBS-Specific Beliefs and Coping
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bruce D Naliboff, PhD, University of California Los Angeles, West Los Angeles VA Healthcare System
- Principal Investigator: Michelle G Craske, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 24, 2006
First Submitted That Met QC Criteria
August 24, 2006
First Posted (Estimate)
August 25, 2006
Study Record Updates
Last Update Posted (Estimate)
November 28, 2016
Last Update Submitted That Met QC Criteria
November 23, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01NR007768 (U.S. NIH Grant/Contract)
- DK-NR07768
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.