Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT00073333
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D010698', 'term': 'Phobic Disorders'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deborah.beidel@ucf.edu', 'phone': '407-823-3254', 'title': 'Deborah C. Beidel, Ph.D.', 'organization': 'University of Central Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Social Effectiveness Therapy', 'description': 'Social skills training and exposure therapy - each conducted once per week.', 'otherNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Imaginal and In Vivo Exposure', 'description': 'Exposure treatment - imaginal and in vivo exposure conducted twice per week', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Attention Placebo Control', 'description': 'Placebo - attention placebo control condition consisting of weekly telephone contact', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Social Phobia Remission', 'timeFrame': 'Measured at Month 12', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Score on the SPAI', 'timeFrame': 'Measured at Month 12', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Social Phobia Remission Rate at 6 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Effectiveness Therapy', 'description': 'Social skills training and exposure therapy - each conducted once per week.'}, {'id': 'OG001', 'title': 'Imaginal and In Vivo Exposure', 'description': 'Exposure treatment - imaginal and in vivo exposure conducted twice per week'}, {'id': 'OG002', 'title': 'Attention Placebo Control', 'description': 'Placebo - attention placebo control condition consisting of weekly telephone contact'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Wait list was treated at the end of 12 weeks', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month follow up', 'description': 'Lack of SocialPhobia Diagnosis at 6 month follow-up', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1Social Effectiveness Therapy', 'description': 'Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly.'}, {'id': 'FG001', 'title': '2Imaginal and In Vivo Exposure', 'description': 'Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice'}, {'id': 'FG002', 'title': '3Attention Placebo', 'description': 'Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There were two studies contained in this grant. Study 1 was an assessment study and consisted of 379 participants - 200 normal controls and 179 participants with social phobia. Study 2 was a treatment study that consisted of 106 participants with social phobia. That is the study described below.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1Social Effectiveness Therapy', 'description': 'Social skills training and exposure therapy - each conducted once per week.'}, {'id': 'BG001', 'title': '2Imaginal and in Vivo Exposure', 'description': 'Exposure treatment - imaginal and in vivo exposure conducted twice per week'}, {'id': 'BG002', 'title': 'Attention Placebo Control', 'description': 'Placebo - attention placebo control condition consisting of weekly telephone contact'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '36.1', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '36.4', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '36.3', 'spread': '13.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-01', 'studyFirstSubmitDate': '2003-11-19', 'resultsFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2003-11-20', 'lastUpdatePostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-14', 'studyFirstPostDateStruct': {'date': '2003-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Phobia Remission', 'timeFrame': 'Measured at Month 12'}, {'measure': 'Social Phobia Remission Rate at 6 Month Follow-up', 'timeFrame': '6 month follow up', 'description': 'Lack of SocialPhobia Diagnosis at 6 month follow-up'}], 'secondaryOutcomes': [{'measure': 'Score on the SPAI', 'timeFrame': 'Measured at Month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phobic Disorders'], 'conditions': ['Social Phobia']}, 'descriptionModule': {'briefSummary': 'This study will determine whether people with social phobia are deficient in certain social skills.', 'detailedDescription': 'Social phobia is a debilitating condition that can cause severe social, emotional, educational, and occupational functioning problems. Evidence suggests that individuals with social phobia are deficient in social skills, but the exact skills deficits have not been elucidated. This study will comprise two substudies: one will examine social skills deficits in social phobics and determine how they differ from those of people without social phobia; the other will determine if skills deficits in social phobics can be improved and whether improvements will affect overall social functioning.\n\nParticipants in this study will be randomly assigned to one of three groups for 16 weeks: an exposure group, a social skills training and exposure (SET) group, or a wait-list control group. Interviews, self-reports, and simulated role plays will be used to assess the social skills of participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Social Phobia\n\nExclusion Criteria:\n\n* Axis II diagnosis of schizoid or schizotypal personality disorder or paranoia\n* Axis II diagnosis of mental retardation, obsessive-compulsive disorder, and personality disorders, except for avoidant personality disorder\n* Instability on any antidepressants\n* Psychotic disorder'}, 'identificationModule': {'nctId': 'NCT00073333', 'briefTitle': 'Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Social Phobia: Assessment and Treatment of Social Skills', 'orgStudyIdInfo': {'id': 'R01MH062547', 'link': 'https://reporter.nih.gov/quickSearch/R01MH062547', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH062547', 'link': 'https://reporter.nih.gov/quickSearch/R01MH062547', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Social skills training and exposure', 'interventionNames': ['Behavioral: Social Skills Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Exposure treatment', 'interventionNames': ['Behavioral: Exposure Treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'Social Skills Training', 'type': 'BEHAVIORAL', 'description': 'Social skills training once per week', 'armGroupLabels': ['1']}, {'name': 'Exposure Treatment', 'type': 'BEHAVIORAL', 'description': 'Exposure once per week', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'Placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Deborah C. Beidel', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}