Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-30 @ 3:05 AM
Study NCT ID:
NCT00679003
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2008-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D055809', 'term': 'Illness Behavior'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2008-05-14', 'studyFirstSubmitQcDate': '2008-05-15', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Disability Inventory', 'timeFrame': 'Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment'}], 'secondaryOutcomes': [{'measure': 'School absences', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months post-treatment'}, {'measure': 'Health care utilization for IBD', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months post-treatment'}, {'measure': 'Pediatric Quality of Life', 'timeFrame': 'Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'Ulcerative colitis', 'Inflammatory bowel disease', 'Illness behavior', 'Cognitive behavioral therapy'], 'conditions': ['Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '40243391', 'type': 'DERIVED', 'citation': 'Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.'}, {'pmid': '28238483', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child has been diagnosed for at least 3 months\n* Child age is 8-17\n* Child has lived with primary caregiver full-time for at least the past 5 years and for at least half of his/ her lifetime\n* Child is medically approved to engage in normal daily activities\n\nExclusion Criteria:\n\n* Chronic disease other than IBD (e.g., pancreatitis, diabetes, epilepsy)\n* Major surgery in past year unrelated to IBD\n* Developmental disabilities that require full-time special education or that impair ability to respond to treatment'}, 'identificationModule': {'nctId': 'NCT00679003', 'acronym': 'Managing IBD', 'briefTitle': 'Managing Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Psychosocial Intervention for Children With IBD', 'orgStudyIdInfo': {'id': 'CHRMC12395'}, 'secondaryIdInfos': [{'id': '1R01HD050345-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD050345-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Social learning and cognitive behavioral therapy (SLCBT)', 'interventionNames': ['Behavioral: SLCBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Education and support (ES)', 'interventionNames': ['Behavioral: ES']}], 'interventions': [{'name': 'SLCBT', 'type': 'BEHAVIORAL', 'description': 'Social learning and cognitive behavioral therapy', 'armGroupLabels': ['1']}, {'name': 'ES', 'type': 'BEHAVIORAL', 'description': 'Education and support (information about nutrition and gastrointestinal system)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rona L Levy, MSW, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Tasha B Murphy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rona Levy', 'investigatorAffiliation': 'University of Washington'}}}}