Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT05018260
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Bias Modification Versus Attention Control in Treatment of 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'particiapants, investigators and outcome assessors are blind to allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-01', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline -Attention Control Scale- ACS', 'timeFrame': 'at baseline, one week after end of intervention', 'description': 'The Attention Control Scale (ACS) assesses attention control, using 20 items rated from 1 to 4. The total score ranging from 20 to 80, with higher scores mean better outcome.'}, {'measure': 'Change from baseline - Patient Health Questionnaire- PHQ9', 'timeFrame': 'at baseline, one week after end of intervention', 'description': 'The Patient Health Questionnaire (PHQ9) assesses depressive symptoms using a self-report, 9 question questionnaire. Items are rated on a scale of 0-3 representing the frequency of depressive symptoms over the past 2 weeks. Scores range between 0 to 27, with higher scores mean worse outcome.'}, {'measure': 'Viewing patterns on disgusted and neutral faces, and round/sharp shapes< representing attention bias.', 'timeFrame': 'at baseline, one week after end of intervention', 'description': 'gaze patterns measured using an established eye tracking task, measuring dwell time on different types of stimuli within a 4X4 matrix.'}, {'measure': 'reaction times on the Flanker task, representing attention control', 'timeFrame': 'at baseline, one week after end of intervention', 'description': 'attention control will be measured using the established Flanker test, to assess change from baseline following treatment.'}], 'primaryOutcomes': [{'measure': 'Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores', 'timeFrame': 'at baseline, one week after end of intervention', 'description': 'The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. The minimum and maximum values of the LSAS total score are 0 and 144, respectively, with higher scores mean worse outcome. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline - the Social Phobia Inventory scores', 'timeFrame': 'at baseline, one week after end of intervention', 'description': 'This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a total score ranging from 0 to 68. Higher scores mean worse outcome.'}, {'measure': 'Clinical Global Impression', 'timeFrame': 'at baseline, one week after end of intervention', 'description': 'A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7. Higher scores mean worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['social anxiety', 'social phobia', 'attention bias modification', 'attention control'], 'conditions': ['Social Anxiety Disorder (Social Phobia)', 'Social Anxiety', 'Social Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (GC-MRT) with attention control treatment based on a similar paradigm, for social anxiety disorder (SAD)', 'detailedDescription': 'This study examines the possibility that the effectiveness shown for GC-MRT in the treatment of SAD leans on attention control rather than bias modification. Therefore half of the participants will receive the classic GC-MRT course of treatment while the other half a version of the task with non-emotional stimuli (geometric shapes).'}, '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* Men and women between the ages of 18 and 65.\n* Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV.\n* SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders.\n* No current pharmaco-therapy.\n\nExclusion Criteria:\n\n* A diagnosis of psychotic or bipolar disorders.\n* A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).\n* Drug or alcohol abuse.\n* Any current pharmacological treatment.\n* Any current psychotherapeutic treatment.\n* Change in treatment during the study.\n* Poor judgment capacity (i.e., children under 18 and special populations).'}, 'identificationModule': {'nctId': 'NCT05018260', 'briefTitle': 'Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety', 'orgStudyIdInfo': {'id': 'TAUAttentionControl'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GCMRT', 'description': 'Attention bias modification: participants will receive gaze-contingent feedback according to their viewing patterns on disgusted and neutral faces', 'interventionNames': ['Behavioral: Attention Bias Modification']}, {'type': 'EXPERIMENTAL', 'label': 'attention control', 'description': 'Attention control modification: participants will receive gaze-contingent feedback according to their viewing patterns on rounded and sharp geometric shapes', 'interventionNames': ['Behavioral: Attention Control']}], 'interventions': [{'name': 'Attention Bias Modification', 'type': 'BEHAVIORAL', 'description': "Feedback according to participants' viewing patterns, in order to modify their attention bias to threat", 'armGroupLabels': ['GCMRT']}, {'name': 'Attention Control', 'type': 'BEHAVIORAL', 'description': "Feedback according to participants' viewing patterns, in order to strengthen their attention control", 'armGroupLabels': ['attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55555', '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'}}}}