An interventional study of SLCBT and ES in Inflammatory Bowel Disease, Crohn's Disease and Ulcerative Colitis, sponsored by University of Washington. Completed. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-04-15.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 190 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
Social learning and cognitive behavioral therapy (SLCBT)
Behavioral: SLCBT
Education and support (ES)
Behavioral: ES
Social learning and cognitive behavioral therapy
Education and support (information about nutrition and gastrointestinal system)
Functional Disability Inventory
Time frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment
School absences
Time frame: Baseline, 3 months, 6 months and 12 months post-treatment
Health care utilization for IBD
Time frame: Baseline, 3 months, 6 months and 12 months post-treatment
Pediatric Quality of Life
Time frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment
No study locations are listed for this record.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University of Washington