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Managing Inflammatory Bowel Disease

Psychosocial Intervention for Children With IBD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00679003
Acronym
Managing IBD
Enrollment
190
Registered
2008-05-16
Start date
2007-09-30
Completion date
2014-03-31
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Keywords

Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Illness behavior, Cognitive behavioral therapy

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.

Interventions

BEHAVIORALSLCBT

Social learning and cognitive behavioral therapy

BEHAVIORALES

Education and support (information about nutrition and gastrointestinal system)

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Seattle Children's Hospital
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Functional Disability InventoryBaseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment

Secondary

MeasureTime frame
School absencesBaseline, 3 months, 6 months and 12 months post-treatment
Health care utilization for IBDBaseline, 3 months, 6 months and 12 months post-treatment
Pediatric Quality of LifeBaseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026