Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT01503151
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2011-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Biases Modification Treatment for Social Anxiety
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2011-12-29', 'studyFirstSubmitQcDate': '2011-12-30', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Anxiety Scale (LSAS) - diagnostic interview', 'timeFrame': 'Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols', 'description': 'LSAS is a 24-items clinician-administered scale developed for the assessment of fear and avoidance associated with social. The LSAS assesses a wide range of both social interaction and performance/observation situations, which are rated for degree of fear/anxiety and frequency of avoidance.'}], 'secondaryOutcomes': [{'measure': 'The Mini International Neuropsychiatric Interview (MINI).', 'timeFrame': 'expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols', 'description': 'The Mini International Neuropsychiatric Interview (MINI) is a short diagnostic structured interview (DSI) developed to explore 17 disorders according to Diagnostic and Statistical Manual diagnostic criteria (DSM)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['attention bias modification treatment', 'interpretive bias modification', 'cognitive bias modification', 'attention training', 'social anxiety'], 'conditions': ['Social Phobia']}, 'descriptionModule': {'briefSummary': 'Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns.\n\nOutcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on DSM-IV criteria.\n\nThe investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeople suffering from social anxiety\n\nExclusion Criteria:\n\nPharmacological or Psychological treatment'}, 'identificationModule': {'nctId': 'NCT01503151', 'acronym': 'CBMSP', 'briefTitle': 'Cognitive Biases Modification Treatment for Social Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Cognitive Biases Modification Treatment for Social Anxiety', 'orgStudyIdInfo': {'id': 'CBM_SP_2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'repeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns.', 'interventionNames': ['Behavioral: Control Condition']}, {'type': 'EXPERIMENTAL', 'label': 'Attention Bias Modification (ABM)', 'description': 'Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.', 'interventionNames': ['Behavioral: Attention Bias Modification Treatment (ABMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Interpretation Bias Modification (IBM)', 'description': 'Interpretation training intended to facilitating a more benign interpretation bias', 'interventionNames': ['Behavioral: Interpretation Bias Modification (IBM)']}, {'type': 'EXPERIMENTAL', 'label': 'Attention and interpretation biases modification', 'description': 'Attention and interpretation training intended to direct cognitive biases away from threat stimulus.', 'interventionNames': ['Behavioral: Attention and Interpretive biases modification (CBM)']}], 'interventions': [{'name': 'Attention Bias Modification Treatment (ABMT)', 'type': 'BEHAVIORAL', 'description': 'Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.', 'armGroupLabels': ['Attention Bias Modification (ABM)']}, {'name': 'Interpretation Bias Modification (IBM)', 'type': 'BEHAVIORAL', 'description': 'Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.', 'armGroupLabels': ['Interpretation Bias Modification (IBM)']}, {'name': 'Control Condition', 'type': 'BEHAVIORAL', 'description': 'Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.', 'armGroupLabels': ['Placebo']}, {'name': 'Attention and Interpretive biases modification (CBM)', 'type': 'BEHAVIORAL', 'description': 'Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.', 'armGroupLabels': ['Attention and interpretation biases modification']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Yair Bar-Haim', 'investigatorAffiliation': 'Tel Aviv University'}}}}