Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-09 @ 9:18 PM
Study NCT ID:
NCT02363205
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment, six months and 12 months post treatment.'}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment, six months and 12 months post treatment.'}, {'measure': 'Social Interaction Anxiety Scale (SIAS)', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment, six months and 12 months post treatment.'}, {'measure': 'The General Self-Efficacy Scale (GSE)', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment, six months and 12 months post treatment.'}, {'measure': 'Subscale Life activites, WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment, six months and 12 months post treatment.'}, {'measure': 'Knowledge of CBT strategies (developed by the research group)', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment, six months and 12 months post treatment.'}, {'measure': 'Patient Health Questionnaire (PHQ)', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment'}, {'measure': 'The Mood and Feelings Questionnaire (MFQ)', 'timeFrame': 'Baseline, post treatment, 6 months- and 12 months post treatment', 'description': 'Change from baseline to post treatment, six months and 12 months post treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '31682572', 'type': 'DERIVED', 'citation': 'Topooco N, Bylehn S, Dahlstrom Nysater E, Holmlund J, Lindegaard J, Johansson S, Aberg L, Bergman Nordgren L, Zetterqvist M, Andersson G. Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 1;21(11):e13393. doi: 10.2196/13393.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms.', 'detailedDescription': 'As above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between the ages of 15-19 years old\n* Have symptoms of depression, major depression\n\nExclusion Criteria:\n\n* Suicidal ideation\n* Alcohol addiction\n* other major primary psychiatric disorder\n* Ongoing psychological treatment\n* recent (during last 4 weeks) change in psychiatric medication'}, 'identificationModule': {'nctId': 'NCT02363205', 'briefTitle': 'Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Guided Internet-Delivered and Tailored Cognitive Behaviour Therapy for Adolescents With Depression: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2014/427-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Weekly check-up'}, {'type': 'EXPERIMENTAL', 'label': 'internet-delivered CBT', 'description': 'Tailored Internet-administrated CBT-Treatment', 'interventionNames': ['Behavioral: Tailored Internet-administrated CBT-Treatment']}], 'interventions': [{'name': 'Tailored Internet-administrated CBT-Treatment', 'type': 'BEHAVIORAL', 'description': 'Guided internet-delivered CBT with chat sessions', 'armGroupLabels': ['internet-delivered CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58183', 'city': 'Linköping', 'state': 'Östergotland', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Gerhard Andersson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}