Managing Inflammatory Bowel Disease (Managing IBD)
Primary Purpose
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SLCBT
ES
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Illness behavior, Cognitive behavioral therapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Social learning and cognitive behavioral therapy (SLCBT)
Education and support (ES)
Outcomes
Primary Outcome Measures
Functional Disability Inventory
Secondary Outcome Measures
School absences
Health care utilization for IBD
Pediatric Quality of Life
Full Information
NCT ID
NCT00679003
First Posted
May 14, 2008
Last Updated
April 14, 2015
Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), Seattle Children's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00679003
Brief Title
Managing Inflammatory Bowel Disease
Acronym
Managing IBD
Official Title
Psychosocial Intervention for Children With IBD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), Seattle Children's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
Keywords
Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Illness behavior, Cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Social learning and cognitive behavioral therapy (SLCBT)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Education and support (ES)
Intervention Type
Behavioral
Intervention Name(s)
SLCBT
Intervention Description
Social learning and cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
ES
Intervention Description
Education and support (information about nutrition and gastrointestinal system)
Primary Outcome Measure Information:
Title
Functional Disability Inventory
Time Frame
Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment
Secondary Outcome Measure Information:
Title
School absences
Time Frame
Baseline, 3 months, 6 months and 12 months post-treatment
Title
Health care utilization for IBD
Time Frame
Baseline, 3 months, 6 months and 12 months post-treatment
Title
Pediatric Quality of Life
Time Frame
Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rona L Levy, MSW, PhD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tasha B Murphy, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28238483
Citation
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.
Results Reference
derived
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Managing Inflammatory Bowel Disease
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