Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT02105259
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2014-04-02', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liebowitz Social Anxiety Scale', 'timeFrame': 'Baseline and End of treatment (10 weeks)'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire Depression 9 item', 'timeFrame': 'Baseline'}, {'measure': 'Patient Health Questionnaire Depression 9 item', 'timeFrame': 'End of treatment (10 weeks)'}, {'measure': 'Patient Health Questionnaire Anxiety 7 item', 'timeFrame': 'Baseline'}, {'measure': 'Patient Health Questionnaire Anxiety 7 item', 'timeFrame': 'End of treatment (10 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Test', 'psychodynamic', 'Internet-delivered psychodynamic treatment', 'patients with social anxiety disorder'], 'conditions': ['Social Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '29251954', 'type': 'DERIVED', 'citation': 'Johansson R, Hesslow T, Ljotsson B, Jansson A, Jonsson L, Fardig S, Karlsson J, Hesser H, Frederick RJ, Lilliengren P, Carlbring P, Andersson G. Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up. Psychotherapy (Chic). 2017 Dec;54(4):351-360. doi: 10.1037/pst0000147.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.', 'detailedDescription': 'Participants with social anxiety disorder (MINI telephone interview) will be recruited via mass media and randomly allocated to psychodynamic Internet--delivered psychological treatment or to a waiting list control condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Social anxiety disorder as diagnosed by the MINI diagnostic interview\n\nExclusion Criteria:\n\n* Severe depression'}, 'identificationModule': {'nctId': 'NCT02105259', 'acronym': 'SOFIA', 'briefTitle': 'Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GA-ANX2014-APT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychodynamic Internet Treatment', 'description': 'Psychodynamic Internet Treatment for social anxiety disorder during 10 weeks and guided by a psychologist', 'interventionNames': ['Behavioral: Psychodynamic Internet Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waiting list with support', 'description': 'Behavioral: supportive check-ups via the Internet during 10 weeks', 'interventionNames': ['Other: Waiting list']}], 'interventions': [{'name': 'Psychodynamic Internet Treatment', 'type': 'BEHAVIORAL', 'description': 'Psychodynamic Internet Treatment for patients social anxiety disorder', 'armGroupLabels': ['Psychodynamic Internet Treatment']}, {'name': 'Waiting list', 'type': 'OTHER', 'description': 'Waiting list, where participants wait for delayed treatment', 'armGroupLabels': ['Waiting list with support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58183', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Department of Behavioural Sciences and Learning, 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'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Stockholm University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}