Managing Inflammatory Bowel Disease

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Psychosocial Intervention for Children With IBD

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Behavioral: SLCBT
* Behavioral: ES


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Social learning and cognitive behavioral therapy (SLCBT) | Behavioral: SLCBT<br>* Social learning and cognitive behavioral therapy<br>|
| Active Comparator: 2<br>Education and support (ES) | Behavioral: ES<br>* Education and support (information about nutrition and gastrointestinal system)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Illness behavior, Cognitive behavioral therapy