A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome
This study has been completed.
Sponsor:
University of California, Los Angeles
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
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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 May 23, 2013