Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-02 @ 1:34 AM
Study NCT ID:
NCT00735995
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2008-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001010', 'term': 'Anxiety, Separation'}, {'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D010698', 'term': 'Phobic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2008-08-13', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth', 'timeFrame': 'post-treatment and 2 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Symptom score on the MASC', 'timeFrame': 'post-treatment and 2 year follow-up'}, {'measure': 'CGAS', 'timeFrame': 'post-treatment and 2 year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Separation Anxiety Disorder', 'Social Phobia', 'Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '23108976', 'type': 'RESULT', 'citation': "Gere MK, Hagen KA, Villabo MA, Arnberg K, Neumer SP, Torgersen S. Fathers' mental health as a protective factor in the relationship between maternal and child depressive symptoms. Depress Anxiety. 2013 Jan;30(1):31-8. doi: 10.1002/da.22010. Epub 2012 Oct 25."}, {'pmid': '23257654', 'type': 'RESULT', 'citation': 'Villabo MA, Cummings CM, Gere MK, Torgersen S, Kendall PC. Anxious youth in research and service clinics. J Anxiety Disord. 2013 Jan;27(1):16-24. doi: 10.1016/j.janxdis.2012.09.003. Epub 2012 Sep 25.'}, {'type': 'RESULT', 'citation': 'Villabø MA, Gere MK, Torgersen S, Arnberg K, Neumer SP, Kendall PC. Anxious self-statements in clinic-referred US and Norwegian anxiety-disordered youth. Cognitive Therapy and Research 37(4): 840-850, 2013.'}, {'pmid': '22659077', 'type': 'RESULT', 'citation': 'Gere MK, Villabo MA, Torgersen S, Kendall PC. Overprotective parenting and child anxiety: the role of co-occurring child behavior problems. J Anxiety Disord. 2012 Aug;26(6):642-9. doi: 10.1016/j.janxdis.2012.04.003. Epub 2012 May 14.'}, {'pmid': '22233247', 'type': 'RESULT', 'citation': 'Villabo M, Gere M, Torgersen S, March JS, Kendall PC. Diagnostic efficiency of the child and parent versions of the Multidimensional Anxiety Scale for Children. J Clin Child Adolesc Psychol. 2012;41(1):75-85. doi: 10.1080/15374416.2012.632350.'}, {'pmid': '30138014', 'type': 'RESULT', 'citation': 'Villabo MA, Narayanan M, Compton SN, Kendall PC, Neumer SP. Cognitive-behavioral therapy for youth anxiety: An effectiveness evaluation in community practice. J Consult Clin Psychol. 2018 Sep;86(9):751-764. doi: 10.1037/ccp0000326.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics. The treatment will be conducted as individual therapy or group therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the ADIS interview schedule, DSM-IV criteria\n\nExclusion Criteria:\n\n* Pervasive Developmental Disorder\n* Psychotic symptoms\n* Intelligence score \\< 70\n* Use of medications with anxiety reducing effects during treatment\n* Neither parent competent in Norwegian language'}, 'identificationModule': {'nctId': 'NCT00735995', 'briefTitle': 'Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway', 'organization': {'class': 'OTHER', 'fullName': 'Regionsenter for barn og unges psykiske helse'}, 'officialTitle': 'Effectiveness of Group and Individual Treatment of Childhood Anxiety Disorders in Community Clinics. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '186036/V50'}, 'secondaryIdInfos': [{'id': '186036', 'type': 'OTHER_GRANT', 'domain': 'Norwegian Research Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Individual CBT', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (individual)']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Group CBT', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (group)']}, {'type': 'NO_INTERVENTION', 'label': 'C', 'description': 'Waiting-list control'}], 'interventions': [{'name': 'Cognitive behavioral therapy (individual)', 'type': 'BEHAVIORAL', 'description': 'The Coping Cat program, 12 weekly sessions, two additional parent meetings', 'armGroupLabels': ['A']}, {'name': 'Cognitive behavioral therapy (group)', 'type': 'BEHAVIORAL', 'description': 'The Coping Cat program, 12 weekly sessions, two additional parent meetings', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Lorenskog', 'country': 'Norway', 'facility': 'Akershus Universitetssykehus HF'}, {'zip': '1309', 'city': 'Rud', 'country': 'Norway', 'facility': 'Sykehuset Asker og Baerum, Baerum BUP', 'geoPoint': {'lat': 60.43333, 'lon': 11.63333}}, {'city': 'Skien', 'country': 'Norway', 'facility': 'Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}], 'overallOfficials': [{'name': 'Simon-Peter Neumer, dr.philos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regionsenter for barn og unges psykiske helse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionsenter for barn og unges psykiske helse', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Research Council of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr. Simon-Peter Neumer', 'investigatorFullName': 'Simon-Peter Neumer', 'investigatorAffiliation': 'Regionsenter for barn og unges psykiske helse'}}}}