Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT01557894
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2012-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Internet Treatment for Social Phobia in Romania
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'btulbure@gmail.com', 'phone': '+40745753061', 'title': 'Bogdan Tudor Tulbure', 'organization': 'Babes-Bolyai University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "1\\) An active control condition matched for clients' expectations, time, and therapist involvement was not included, 2)Due to personnel constrains, post-intervention SCID interviews were not blinded regarding the study conditions etc."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group', 'otherNumAtRisk': 38, 'otherNumAffected': 38, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)', 'otherNumAtRisk': 38, 'otherNumAffected': 38, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Social Anxiety', 'notes': 'Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that social anxiety represents Other Adverse Events that occurred in all participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.'}, {'id': 'OG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)'}], 'classes': [{'title': 'Pre-intervention assessment', 'categories': [{'measurements': [{'value': '78.60', 'spread': '16.14', 'groupId': 'OG000'}, {'value': '78.47', 'spread': '21.78', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention assessment', 'categories': [{'measurements': [{'value': '73.69', 'spread': '26.46', 'groupId': 'OG000'}, {'value': '43.98', 'spread': '23.17', 'groupId': 'OG001'}]}]}, {'title': 'Six month follow up', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Follow-up data on the waitlist control participants were not collected as this group received an active intervention starting from week 10.', 'groupId': 'OG000'}, {'value': '35.77', 'spread': '25.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was set at .05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) measures social anxiety.\n\nLSAS-SR presents 24 commonly anxiety-provoking situations, and asks participants to rate their fear and avoidance for each situation.\n\nIn order to obtain the total LSAS-SR score the Anxiety and Avoidance subscales scores are added together.\n\nThe LSAS-SR total score ranges from 0-144, with higher scores corresponding to greater social anxiety', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Social Phobia Inventory (SPIN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group'}, {'id': 'OG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)'}], 'classes': [{'title': 'Pre-intervention assessment', 'categories': [{'measurements': [{'value': '45.50', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '45.15', 'spread': '9.69', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention assessment', 'categories': [{'measurements': [{'value': '43.22', 'spread': '10.94', 'groupId': 'OG000'}, {'value': '27.95', 'spread': '13.04', 'groupId': 'OG001'}]}]}, {'title': 'Six month follow up', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Follow-up data on the waitlist control participants were not collected as this group received an active intervention starting from week 10.', 'groupId': 'OG000'}, {'value': '19.74', 'spread': '13.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was set at .05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Social Phobia Inventory (SPIN) is a brief (i.e., 17-item) self-report instrument measuring fear in social situations, avoidance of performance/social events, and physiological discomfort in social situations. Each item is rated on a 4-point scale.\n\nThus, for SPIN the range of scores is 0-68, with higher scores reflecting higher levels of social anxiety symptomatology', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group'}, {'id': 'OG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)'}], 'classes': [{'title': 'Pre-intervention assessment', 'categories': [{'measurements': [{'value': '15.39', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '15.15', 'spread': '7.47', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention assessment', 'categories': [{'measurements': [{'value': '12.77', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '5.95', 'groupId': 'OG001'}]}]}, {'title': 'Six month follow up', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Follow-up data on the waitlist control participants were not collected as this group received an active intervention starting from week 10.', 'groupId': 'OG000'}, {'value': '6.44', 'spread': '7.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'Beck Depression Inventory-II (BDI-II) is a 21-item self-report inventory widely used to assess DSM-IV depressive symptoms. Each item consists of four statements, scored 0-3, indicating increasing symptom severity.\n\nThus, for BDI-II the range of scores is 0-63, with higher scores reflecting higher levels of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Attitude and Belief Scale-II (ABS-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group'}, {'id': 'OG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)'}], 'classes': [{'title': 'Pre-intervention assessment', 'categories': [{'measurements': [{'value': '124.60', 'spread': '41.50', 'groupId': 'OG000'}, {'value': '120.94', 'spread': '39.78', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention assessment', 'categories': [{'measurements': [{'value': '102.51', 'spread': '46.62', 'groupId': 'OG000'}, {'value': '76.62', 'spread': '34.81', 'groupId': 'OG001'}]}]}, {'title': 'Six month follow up', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Follow-up data on the wait-list control participants were not collected as this group received an active intervention starting from week 10.', 'groupId': 'OG000'}, {'value': '57.96', 'spread': '31.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Attitude and Belief Scale-II (ABS-II) measures rational and irrational thinking as described by Albert Ellis. The scale was designed to capture four cognitive processes (i.e., demandingness, awfulizing, low frustration tolerance, and self-downing/global evaluation) in three content areas (i.e., achievement, approval, and comfort). We selected the 72-item ABS-II because preliminary psychometrics are available for the Romanian population.\n\nThe total ABS-II score range from 0 to 360, with higher scores corresponding to greater irrationality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety Sensitivity Index (ASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group'}, {'id': 'OG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)'}], 'classes': [{'title': 'Pre-intervention assessment', 'categories': [{'measurements': [{'value': '29.00', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '29.28', 'spread': '11.40', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention assessment', 'categories': [{'measurements': [{'value': '26.17', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '10.34', 'groupId': 'OG001'}]}]}, {'title': 'Six month follow up', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Follow-up data on the wait-list control participants were not collected as this group received an active intervention starting from week 10.', 'groupId': 'OG000'}, {'value': '13.40', 'spread': '9.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Anxiety Sensitivity Index (ASI) is a 16-item questionnaire that measures the beliefs about the social and somatic consequences of anxiety symptoms. The total ASI score ranges from 0 to 64, with higher scores corresponding to greater anxiety sensitivity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks.\n\nStarting from week 10 these participants received the active intervention.'}, {'id': 'FG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The trial was briefly presented in various national and local newspapers, where a link to the project website (https://www.iterapi.se/sites/isofie) was provided. Interested participants registered online, read the informed consent, and filled in the screening questionnaires over the internet.', 'preAssignmentDetails': 'Of the 291 applicants 47 had high depression 35 had low social anxiety 38 could not be contacted 21 had long travel plans 10 declined participation 9 had other psychological disorders 8 were under 18 years 2 were redirected. Of the remaining 121 interviewed applicants, 66 meet the DSM-IV criteria for SAD, and 10 presented subclinical SAD symptoms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Waitlist Control Group', 'description': 'Wait-list control group'}, {'id': 'BG001', 'title': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)\n\niSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.85', 'spread': '7.83', 'groupId': 'BG000'}, {'value': '30.57', 'spread': '7.96', 'groupId': 'BG001'}, {'value': '28.82', 'spread': '8.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Romania', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-05', 'studyFirstSubmitDate': '2012-03-15', 'resultsFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2012-03-16', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-17', 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) measures social anxiety.\n\nLSAS-SR presents 24 commonly anxiety-provoking situations, and asks participants to rate their fear and avoidance for each situation.\n\nIn order to obtain the total LSAS-SR score the Anxiety and Avoidance subscales scores are added together.\n\nThe LSAS-SR total score ranges from 0-144, with higher scores corresponding to greater social anxiety'}, {'measure': 'Social Phobia Inventory (SPIN)', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Social Phobia Inventory (SPIN) is a brief (i.e., 17-item) self-report instrument measuring fear in social situations, avoidance of performance/social events, and physiological discomfort in social situations. Each item is rated on a 4-point scale.\n\nThus, for SPIN the range of scores is 0-68, with higher scores reflecting higher levels of social anxiety symptomatology'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'Beck Depression Inventory-II (BDI-II) is a 21-item self-report inventory widely used to assess DSM-IV depressive symptoms. Each item consists of four statements, scored 0-3, indicating increasing symptom severity.\n\nThus, for BDI-II the range of scores is 0-63, with higher scores reflecting higher levels of depression.'}, {'measure': 'Attitude and Belief Scale-II (ABS-II)', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Attitude and Belief Scale-II (ABS-II) measures rational and irrational thinking as described by Albert Ellis. The scale was designed to capture four cognitive processes (i.e., demandingness, awfulizing, low frustration tolerance, and self-downing/global evaluation) in three content areas (i.e., achievement, approval, and comfort). We selected the 72-item ABS-II because preliminary psychometrics are available for the Romanian population.\n\nThe total ABS-II score range from 0 to 360, with higher scores corresponding to greater irrationality.'}, {'measure': 'Anxiety Sensitivity Index (ASI)', 'timeFrame': 'pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)', 'description': 'The Anxiety Sensitivity Index (ASI) is a 16-item questionnaire that measures the beliefs about the social and somatic consequences of anxiety symptoms. The total ASI score ranges from 0 to 64, with higher scores corresponding to greater anxiety sensitivity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Social anxiety disorders', 'Social phobia', 'Anxiety sensitivity', 'Irrational thinking', 'Guided self-help', 'Internet-delivered treatment'], 'conditions': ['Phobia, Social']}, 'referencesModule': {'references': [{'pmid': '23111108', 'type': 'BACKGROUND', 'citation': 'Tulbure BT, Mansson KN, Andersson G. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial. Trials. 2012 Oct 30;13:202. doi: 10.1186/1745-6215-13-202.'}, {'pmid': '25938241', 'type': 'DERIVED', 'citation': 'Tulbure BT, Szentagotai A, David O, Stefan S, Mansson KN, David D, Andersson G. Internet-delivered cognitive-behavioral therapy for social anxiety disorder in Romania: a randomized controlled trial. PLoS One. 2015 May 4;10(5):e0123997. doi: 10.1371/journal.pone.0123997. eCollection 2015.'}], 'seeAlsoLinks': [{'url': 'http://www.iterapi.se/sites/isofie/', 'label': 'The public pages of the iSOFIE project (in Romanian)'}]}, 'descriptionModule': {'briefSummary': "The main aim of this study is to investigate the effectiveness of an Internet-delivered intervention for social phobia by comparing it to a waitlist control group. The second aim of the study is to track the potential changes in participants' thinking patterns. Because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility will also be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.", 'detailedDescription': "The primary aim of this study is to investigate the effectiveness of an internet intervention for social phobia (i.e., the iSOFIE) by comparing it to a waitlist control group. iSOFIE was derived from a previously tested program (Furmark, Holmström, Sparthan, Carlbring, \\& Andersson, 2006) and has been significantly shortened while retaining the most important elements. The second aim of the study is to track the potential changes in participants' thinking patterns. While this intervention is primarily based on the cognitive-behavioral model of SAD (Clark and Wells, 1995), and no specific Rational Emotive Behavior Therapy (REBT, Ellis \\& Dryden, 1997) will be implemented, it is hypothesized that the cognitive restructuring and exposure exercises will make participants less prone to irrational thinking (as measured by the Attitude and Belief Scale-II (ABS-II, DiGiuseppe, Leaf, Exner, \\& Robin, 1988). To our knowledge, no study has investigated whether an iCBT program for SAD has the potential to alter participants' irrational thinking patterns. Moreover, because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility of the program will be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years\n* social anxiety disorder is the primary diagnostic (according to the DSM-IV)\n* access to an Internet connected computer\n* be fluent in Romanian language\n\nExclusion Criteria:\n\n* suicidal ideation\n* ongoing psychological treatment for social anxiety disorder\n* recent change in psychiatric medication (i.e., during the last 6 weeks)\n* psychoses or borderline personality disorder'}, 'identificationModule': {'nctId': 'NCT01557894', 'acronym': 'iSOFIE-Ro', 'briefTitle': 'Internet Treatment for Social Phobia in Romania', 'organization': {'class': 'OTHER', 'fullName': 'Babes-Bolyai University'}, 'officialTitle': 'Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TTudor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iSOFIE', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)', 'interventionNames': ['Other: iSOFIE']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'Waitlist control group'}], 'interventions': [{'name': 'iSOFIE', 'type': 'OTHER', 'description': 'Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)', 'armGroupLabels': ['iSOFIE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400084', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Babes-Bolyai University', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'overallOfficials': [{'name': 'Bogdan Tudor Tulbure, post-doc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Babes-Bolyai University, Romania'}, {'name': 'Gerhard Andersson, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Babes-Bolyai University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'post-doctoral researcher', 'investigatorFullName': 'Tulbure Bogdan Tudor', 'investigatorAffiliation': 'Babes-Bolyai University'}}}}