Managing Inflammatory Bowel Disease (Managing IBD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Seattle Children's Hospital
Information provided by (Responsible Party):
Rona Levy, University of Washington
ClinicalTrials.gov Identifier:
NCT00679003
First received: May 14, 2008
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Behavioral: SLCBT
Behavioral: ES

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Psychosocial Intervention for Children With IBD

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Functional Disability Inventory [ Time Frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • School absences [ Time Frame: Baseline, 3 months, 6 months and 12 months post-treatment ] [ Designated as safety issue: No ]
  • Health care utilization for IBD [ Time Frame: Baseline, 3 months, 6 months and 12 months post-treatment ] [ Designated as safety issue: No ]
  • Pediatric Quality of Life [ Time Frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Social learning and cognitive behavioral therapy (SLCBT)
Behavioral: SLCBT
Social learning and cognitive behavioral therapy
Active Comparator: 2
Education and support (ES)
Behavioral: ES
Education and support (information about nutrition and gastrointestinal system)

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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679003

Sponsors and Collaborators
University of Washington
Seattle Children's Hospital
Investigators
Principal Investigator: Rona L Levy, MSW, PhD, MPH University of Washington
Study Director: Shelby L Langer, PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Rona Levy, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00679003     History of Changes
Other Study ID Numbers: CHRMC12395, 1R01HD050345-01A2
Study First Received: May 14, 2008
Last Updated: March 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Crohn's disease
Ulcerative colitis
Inflammatory bowel disease
Illness behavior
Cognitive behavioral therapy

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014