Clinical trial NCT00679003: Managing Inflammatory Bowel Disease
Official title: Psychosocial Intervention for Children With IBD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's disease
Ulcerative colitis
Inflammatory bowel disease
Illness behavior
Cognitive behavioral therapy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Seattle Children's Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-05-16
Enrollment: 190
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Functional Disability Inventory
timeFrame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment
Secondary outcomes:
measure: School absences
timeFrame: Baseline, 3 months, 6 months and 12 months post-treatment
measure: Health care utilization for IBD
timeFrame: Baseline, 3 months, 6 months and 12 months post-treatment
measure: Pediatric Quality of Life
timeFrame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Rona L Levy, MSW, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Tasha B Murphy, PhD
role: STUDY_DIRECTOR
References:
citation: van Tilburg MAL, Claar RL, Romano JM, Langer SL, Drossman DA, Whitehead WE, Abdullah B, Levy RL. Psychological Factors May Play an Important Role in Pediatric Crohn's Disease Symptoms and Disability. J Pediatr. 2017 May;184:94-100.e1. doi: 10.1016/j.jpeds.2017.01.058. Epub 2017 Feb 24.