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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bruce Naliboff, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00368771
First received: August 24, 2006
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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 Intervention
Irritable Bowel Syndrome
Behavioral: IBS Stress Management
Behavioral: IBS Symptom Management
Behavioral: IBS Educational Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Changes in Symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IBS-specific Quality of Life increase [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • IBS-Specific Beliefs and Coping [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: July 2002
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368771

Sponsors and Collaborators
University of California, Los Angeles
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
  More Information

Additional Information:
Publications:
Responsible Party: Bruce Naliboff, PhD, Research Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00368771     History of Changes
Other Study ID Numbers: R01NR007768, R01NR007768, DK-NR07768
Study First Received: August 24, 2006
Last Updated: May 21, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 16, 2014