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OpenTrials
Completed

NCT Number: NCT00679003

Managing Inflammatory Bowel Disease

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLCBT

Behavioral

Social learning and cognitive behavioral therapy

ES

Behavioral

Education and support (information about nutrition and gastrointestinal system)

Primary outcomes

  1. Functional Disability Inventory

    Time frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment

Secondary outcomes

  1. School absences

    Time frame: Baseline, 3 months, 6 months and 12 months post-treatment

  2. Health care utilization for IBD

    Time frame: Baseline, 3 months, 6 months and 12 months post-treatment

  3. Pediatric Quality of Life

    Time frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)
  • Seattle Children's Hospital

Registry information

Official study title

Psychosocial Intervention for Children With IBD

Acronym: Managing IBD

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
May 16, 2008
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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