Managing Inflammatory Bowel Disease (Managing IBD)

Psychosocial Intervention for Children With IBD

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease
• Intervention / Treatment: Behavioral: SLCBT; Behavioral: ES

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.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Disability Inventory	Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
School absences	Baseline, 3 months, 6 months and 12 months post-treatment
Health care utilization for IBD	Baseline, 3 months, 6 months and 12 months post-treatment
Pediatric Quality of Life	Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); Seattle Children's Hospital
• Investigators: Principal Investigator: Rona L Levy, MSW, PhD, MPH, University of Washington; Study Director: Tasha B Murphy, PhD, University of Washington

Publications and helpful links

General Publications

• van Tilburg MAL, Claar RL, Romano JM, Langer SL, Drossman DA, Whitehead WE, Abdullah B, Levy RL. Psychological Factors May Play an Important Role in Pediatric Crohn's Disease Symptoms and Disability. J Pediatr. 2017 May;184:94-100.e1. doi: 10.1016/j.jpeds.2017.01.058. Epub 2017 Feb 24.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 15, 2008
• First Posted (Estimate): May 16, 2008

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Crohn's disease; Ulcerative colitis; Inflammatory bowel disease; Illness behavior
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CHRMC12395; 1R01HD050345-01A2 (U.S. NIH Grant/Contract)