Managing Inflammatory Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Social learning and cognitive behavioral therapy (SLCBT)

Group Type EXPERIMENTAL

SLCBT

Intervention Type BEHAVIORAL

Social learning and cognitive behavioral therapy

2

Education and support (ES)

Group Type ACTIVE_COMPARATOR

ES

Intervention Type BEHAVIORAL

Education and support (information about nutrition and gastrointestinal system)

Interventions

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SLCBT

Social learning and cognitive behavioral therapy

Intervention Type BEHAVIORAL

ES

Education and support (information about nutrition and gastrointestinal system)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No