A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368771
Recruitment Status : Completed
First Posted : August 25, 2006
Last Update Posted : November 28, 2016
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: IBS Stress Management Behavioral: IBS Symptom Management Behavioral: IBS Educational Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Six-Month Study to Compare Outcome Differences and Visceral Response in Subjects Randomized to a Psychological Intervention for Irritable Bowel Syndrome
Study Start Date : July 2002
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Active Comparator: 1
IBS Stress Management
Behavioral: 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
Behavioral: 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
Behavioral: 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.

Primary Outcome Measures :
  1. Changes in Symptoms [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. IBS-specific Quality of Life increase [ Time Frame: 14 days ]
  2. IBS-Specific Beliefs and Coping [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00368771

Sponsors and Collaborators
University of California, Los Angeles
National Institute of Nursing Research (NINR)
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

Additional Information:
Publications of Results:
Responsible Party: University of California, Los Angeles Identifier: NCT00368771     History of Changes
Other Study ID Numbers: R01NR007768 ( U.S. NIH Grant/Contract )
R01NR007768 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2006    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by University of California, Los Angeles:
Irritable Bowel Syndrome
Abdominal Pain
Abdominal Discomfort

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases