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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
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

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

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

    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)
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    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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