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| Sponsor: | University of Washington |
|---|---|
| Collaborator: |
National Institute of Nursing Research (NINR) |
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00907790 |
Purpose
The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome |
Behavioral: Usual Care Behavioral: Comprehensive Self-Management |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Nursing Management of IBS:Improving Outcomes |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CSM |
Behavioral: Comprehensive Self-Management
Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS
|
| No Intervention: Usual Care |
Behavioral: Usual Care
Includes the usual care provided by the person and their health care provider.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Monica E Jarrett, PhD | 206-543-2348 | jarrett@u.washington.edu |
| Contact: Anne Poppe, PhC | 206-616-9955 | apoppe@u.washington.edu |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Monica E Jarrett, PhD 206-543-2348 jarrett@u.washington.edu | |
| Contact: Anne Poppe, PhC 206-616-9955 apoppe@u.washington.edu | |
| Principal Investigator: | Maargaret M Heitkemper, PhD | University of Washington |
More Information
| Responsible Party: | Margaret Heitkemper, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00907790 History of Changes |
| Other Study ID Numbers: | 32722-G, 2R01NR004142 |
| Study First Received: | May 21, 2009 |
| Last Updated: | November 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Irritable Bowel Syndrome Cognitive Therapy Abdominal Pain Quality of Life |
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |