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Managing Inflammatory Bowel Disease - NCT00679003-98105(Clinical Trial 221235)



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City:  Seattle
State:  
WA
Zip Code: 98105
Conditions: Inflammatory Bowel Disease - Crohn's Disease - Ulcerative Colitis
Purpose: 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.
Study summary: 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.
Criteria: Inclusion Criteria: - Child has been diagnosed for at least 3 months - Child age is 8-17 - Child has lived with primary caregiver full-time for at least the past 5 years and for at least half of his/ her lifetime - Child is medically approved to engage in normal daily activities Exclusion Criteria: - Chronic disease other than IBD (e.g., pancreatitis, diabetes, epilepsy) - Major surgery in past year unrelated to IBD - Developmental disabilities that require full-time special education or that impair ability to respond to treatment
Study is available at: Seattle Children's Hospital
Seattle, WA 98105
United States

Primary Contact:
Melissa Coffey, BA
Email: melissa.coffey@seattlechildrens.org
Phone: 206-987-1062
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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