Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-03 @ 8:11 AM
Study NCT ID:
NCT01533402
Status:
COMPLETED
Last Update Posted:
2014-09-09
First Post:
2012-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-08', 'studyFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2012-02-10', 'lastUpdatePostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety symptoms', 'timeFrame': 'two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P).'}], 'secondaryOutcomes': [{'measure': 'Anxiety symptoms', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).'}, {'measure': 'Quality of Life', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Quality of Life (QOLI)'}, {'measure': 'comorbidity', 'timeFrame': 'two - four weeks before treatment starts', 'description': 'Development and Wellbeing Assessment (DAWBA)'}, {'measure': 'Depressive symptoms', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Children Depression Scale (CDI)'}, {'measure': 'Funtional impairment', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Children´s Global Assessment Scale (CGAS)'}, {'measure': 'Client Satisfaction Scale', 'timeFrame': 'two weeks before treatment and 10 weeks, 3 and 12 months post treatment', 'description': 'Client Satisfaction Scale (CSS)'}, {'measure': 'Parental psychopathology', 'timeFrame': 'two weeks pre treatment', 'description': 'Primary Care Evaluation of Mental disorders (Prime-MD)'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment', 'description': 'Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive behavior therapy', 'Internet', 'Anxiety disorders', 'Children'], 'conditions': ['Anxiety Disorders']}, 'referencesModule': {'references': [{'pmid': '28012300', 'type': 'DERIVED', 'citation': 'Vigerland S, Serlachius E, Thulin U, Andersson G, Larsson JO, Ljotsson B. Long-term outcomes and predictors of internet-delivered cognitive behavioral therapy for childhood anxiety disorders. Behav Res Ther. 2017 Mar;90:67-75. doi: 10.1016/j.brat.2016.12.008. Epub 2016 Dec 14.'}, {'pmid': '26649465', 'type': 'DERIVED', 'citation': 'Vigerland S, Ljotsson B, Thulin U, Ost LG, Andersson G, Serlachius E. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Behav Res Ther. 2016 Jan;76:47-56. doi: 10.1016/j.brat.2015.11.006. Epub 2015 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder,\n* age between 8 and 12 years,\n* ability to read and write Swedish and\n* with access to a computer and use of internet.\n\nExclusion Criteria:\n\n* Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.'}, 'identificationModule': {'nctId': 'NCT01533402', 'briefTitle': 'Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2011/2027-31/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Attention control', 'description': 'Weekly support from therapist without CBT-interventions', 'interventionNames': ['Behavioral: therapist support']}, {'type': 'EXPERIMENTAL', 'label': 'Internet CBT', 'description': 'Internet-delivered cognitive behavioural therapy with therapy support', 'interventionNames': ['Behavioral: Internet-delivered CBT']}], 'interventions': [{'name': 'therapist support', 'type': 'BEHAVIORAL', 'description': 'Weekly therapist support without CBT-interventions', 'armGroupLabels': ['Attention control']}, {'name': 'Internet-delivered CBT', 'type': 'BEHAVIORAL', 'description': 'Internet-delivered cognitive behavioural therapy with therapist support', 'armGroupLabels': ['Internet CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '118 91', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Barn-och ungdomspsykiatrin, Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'Barn-och ungdomspsykiatrin (BUP), Stockholm', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, PhD', 'investigatorFullName': 'Eva Serlachius', 'investigatorAffiliation': 'Karolinska Institutet'}}}}