Managing Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease
• Interventions: Behavioral: SLCBT; Behavioral: ES

• Registration Number: NCT00679003
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-16
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SLCBT	Social learning and cognitive behavioral therapy (SLCBT)
2	ES	Education and support (ES)

Primary Outcome Measures

Name	Time	Method
Functional Disability Inventory	Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment

Secondary Outcome Measures

Name	Time	Method
Pediatric Quality of Life	Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment
Health care utilization for IBD	Baseline, 3 months, 6 months and 12 months post-treatment
School absences	Baseline, 3 months, 6 months and 12 months post-treatment