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Sponsors and Collaborators: |
University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00679003 |
Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.
Condition | Intervention |
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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis |
Behavioral: SLCBT Behavioral: ES |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Psychosocial Intervention for Children With IBD |
Estimated Enrollment: | 180 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Social learning and cognitive behavioral therapy
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Behavioral: SLCBT
Social learning and cognitive behavioral therapy
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2: Active Comparator
Education and support
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Behavioral: ES
Education and support (information about nutrition and gastrointestinal system)
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Inflammatory Bowel Disease (Crohn's and ulcerative colitis; IBD), a serious medical condition that affects children and adolescents, is often associated with high rates of health care utilization and disability, including school absences. While psychosocial factors are not believed to cause IBD, research suggests that they may increase illness-related dysfunction. Prior studies suggest that response to chronic illness is, in part, acquired during childhood through social learning processes and may be modified with psychosocial interventions. This randomized controlled trial will compare a social learning and cognitive behavior therapy (SLCBT) treatment to an education and support condition (ES). 180 children with IBD will be recruited and followed for 12 months. It is hypothesized that SLCBT participants, compared to those in the ES condition, will, at one-year follow-up: 1) exhibit greater decreases in IBD symptoms, medical visits for IBD, and functional disability, and greater increases in quality of life; 2) demonstrate greater use of cognitive coping, relaxation and stress management skills, and their parents will demonstrate greater reductions in maladaptive responses to illness behavior; and 3) exhibit greater reductions in anxiety, depression, and somatization. Results will lead to innovative interventions for IBD and other chronic childhood medical conditions.
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
Seattle Children's Hospital | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Melissa Coffey, BA 206-987-1062 melissa.coffey@seattlechildrens.org | |
Contact: Sheri Ballard, BA 206-616-2358 ibdstudy@u.washington.edu |
Principal Investigator: | Rona L Levy, MSW, PhD, MPH | University of Washington |
Study Director: | Shelby L Langer, PhD | University of Washington |
Responsible Party: | University of Washington School of Social Work ( Rona L. Levy, MSW, PhD, MPH / Principal Investigator ) |
Study ID Numbers: | CHRMC12395, 1R01HD050345-01A2 |
Study First Received: | May 14, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00679003 |
Health Authority: | United States: Institutional Review Board |
Crohn's disease Ulcerative colitis Inflammatory bowel disease Illness behavior Cognitive behavioral therapy |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Crohn Disease |
Inflammatory Bowel Diseases Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |
Pathologic Processes |