Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT03424967
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Statistical Learning as a Predictor of Attention Bias Modification Outcome
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores', 'timeFrame': '1-2 weeks after treatment completion', 'description': 'The Liebowitz Social Anxiety Scale is a clinician-rated inventory consisting of 24 items describing socially relevant situations. Each situation is rated in relation to the past week on two sub-scales ranging 0-3: level of fear and level of avoidance experienced in response to these situations. Item scores are summed to a total score ranging 0-144'}], 'secondaryOutcomes': [{'measure': 'The Social Phobia Inventory scores', 'timeFrame': '1-2 weeks after treatment completion', 'description': 'The Social Phobia Inventory is a self-reported questionnaire comprised of 17 items on a 5-point scale depicting social worries and problems. Participants rate to what extent these situations have bothered them in the past week. Item scores are summed to a total score ranging 0-68.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['attention-bias modification', 'statistical learning', 'social anxiety disorder', 'treatment outcome'], 'conditions': ['Social Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'This study examines whether the ability to extract statistical properties from the environment among treatment-seeking patients with social anxiety disorder can predict therapeutic response to attention bias modification (ABM), namely, reduction in symptoms of social anxiety following ABM therapy.', 'detailedDescription': "All participants received 6 sessions of ABM therapy away from threat. At baseline participants also completed a gold standard statistical learning task aimed to assess participants' capacity for the extraction of statistical regularity from the environment. The aim of the study is to determine whether the basic ability to extract rules from the environment at baseline could predict clinical improvement of social anxiety symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a signed consent form\n* a primary diagnosis of social anxiety disorder\n* an age of 18-65\n\nExclusion Criteria:\n\n* any history or present diagnosis of psychosis\n* high risk for harm to self or others\n* concurrent posttraumatic stress disorder, eating disorder, or bipolar disorder\n* a diagnosis of a neurological disorder (i.e., epilepsy, brain injury)\n* drug or alcohol misuse\n* a pharmacological treatment that is not stabilized in the past 3 months\n* any concurrent psychotherapy'}, 'identificationModule': {'nctId': 'NCT03424967', 'briefTitle': 'Statistical Learning as a Predictor of Attention Bias Modification Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Statistical Learning as a Predictor of Attention Bias Modification Outcome: a Preliminary Study Among Socially Anxious Patients', 'orgStudyIdInfo': {'id': 'TAU-SL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABM therapy', 'description': 'The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.', 'interventionNames': ['Behavioral: ABM']}], 'interventions': [{'name': 'ABM', 'type': 'BEHAVIORAL', 'otherNames': ['attention bias modification'], 'description': 'Participants are trained with a dot-probe task including angry-neutral faces. In 80% of trials the probe appears in place of the neutral face, and in 20% of trials in place of the angry face.', 'armGroupLabels': ['ABM therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6997801', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Yair Bar-Haim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yair Bar-Haim', 'investigatorAffiliation': 'Tel Aviv University'}}}}