Managing Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— Managing IBD  

Official title:

Psychosocial Intervention for Children With IBD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679003
• Other study ID #: CHRMC12395
• Secondary ID: 1R01HD050345-01A
• Status: Completed
• Phase: N/A
• First received: May 14, 2008
• Last updated: April 14, 2015
• Start date: September 2007
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Behavioral:
• SLCBT
Social learning and cognitive behavioral therapy
• ES
Education and support (information about nutrition and gastrointestinal system)

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Disability Inventory		Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment	No
Secondary	School absences		Baseline, 3 months, 6 months and 12 months post-treatment	No
Secondary	Health care utilization for IBD		Baseline, 3 months, 6 months and 12 months post-treatment	No
Secondary	Pediatric Quality of Life		Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment	No

External Links

•   Click here for more information about this study: Managing Inflammatory Bowel Disease