Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-26 @ 4:14 PM
Study NCT ID:
NCT00564967
Status:
COMPLETED
Last Update Posted:
2010-10-26
First Post:
2007-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-25', 'studyFirstSubmitDate': '2007-11-28', 'studyFirstSubmitQcDate': '2007-11-28', 'lastUpdatePostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liebowitz Social Anxiety Scale (LSAS)'}], 'secondaryOutcomes': [{'measure': 'SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Social Phobia']}, 'referencesModule': {'references': [{'pmid': '24260145', 'type': 'DERIVED', 'citation': 'Andersson E, Ruck C, Lavebratt C, Hedman E, Schalling M, Lindefors N, Eriksson E, Carlbring P, Andersson G, Furmark T. Genetic polymorphisms in monoamine systems and outcome of cognitive behavior therapy for social anxiety disorder. PLoS One. 2013 Nov 15;8(11):e79015. doi: 10.1371/journal.pone.0079015. eCollection 2013.'}, {'pmid': '22320999', 'type': 'DERIVED', 'citation': 'Hedman E, Andersson E, Ljotsson B, Andersson G, Andersson E, Schalling M, Lindefors N, Ruck C. Clinical and genetic outcome determinants of Internet- and group-based cognitive behavior therapy for social anxiety disorder. Acta Psychiatr Scand. 2012 Aug;126(2):126-36. doi: 10.1111/j.1600-0447.2012.01834.x. Epub 2012 Feb 9.'}, {'pmid': '21483704', 'type': 'DERIVED', 'citation': 'Hedman E, Andersson G, Ljotsson B, Andersson E, Ruck C, Mortberg E, Lindefors N. Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: a randomized controlled non-inferiority trial. PLoS One. 2011 Mar 25;6(3):e18001. doi: 10.1371/journal.pone.0018001.'}], 'seeAlsoLinks': [{'url': 'http://www.internetpsykiatri.se', 'label': 'Information about the study and how to enroll is provided'}]}, 'descriptionModule': {'briefSummary': 'Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social phobia.\n\nTo the investigator´s knowledge, no study has yet directly compared live-CBT to Internet therapy. The aim of the present study is to compare the effect of live CBT vs CBT delivered via the Internet. The study is considered to be an equivalence trial. 128 patients will be randomly assigned to one of the two treatment conditions. The primary outcome measure is Liebowitz Social Anxiety Scale (LSAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a primary diagnosis of social phobia\n\nExclusion Criteria:\n\n* Substance abuse during the last 6 months\n* Other dominating diagnosis (not phobic personality disorder)\n* A history of bipolar disorder or psychosis\n* Major depression according to DSM-IV and \\>20 on madrs-s\n* Risk of suicide\n* Start of medication or change of dosis during the last 2 months\n* Other parallel psychological treatment\n* Previous CBT (last 3 years) for social phobia'}, 'identificationModule': {'nctId': 'NCT00564967', 'acronym': 'IS1', 'briefTitle': 'A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'A Comparison Between Internet-based Self-help Therapy and Group Therapy for Social Phobia - A Clinical Equivalence Trial Using Cognitive Behavioural Therapy (CBT)', 'orgStudyIdInfo': {'id': 'IS1'}, 'secondaryIdInfos': [{'id': 'Dnr 2005/178-31'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'CBT via the Internet', 'interventionNames': ['Behavioral: CBT via the Internet']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '15 weeks, CBT group therapy, 1 session/week (2.5 hours).', 'interventionNames': ['Behavioral: CBT group therapy']}], 'interventions': [{'name': 'CBT via the Internet', 'type': 'BEHAVIORAL', 'description': '15 weeks, patients learn about CBT primarily thru a self-help book published on teh Internet, Minimal therapy contact via e-mail(10 minutes/week),', 'armGroupLabels': ['1']}, {'name': 'CBT group therapy', 'type': 'BEHAVIORAL', 'description': '15 weeks, 1 session/week, (2,5 hours.)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Psykiatri Sydväst, Stockholm County Council', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'nils lindefors', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nils Lindefors, MD, PHD, professor', 'oldOrganization': 'Stockholm County Council and Karolinska Institute'}}}}