Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT04500457
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exposure-Based Treatment for Perfectionism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cougle@psy.fsu.edu', 'phone': '8506458729', 'title': 'Jesse Cougle', 'organization': 'Florida State University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'OG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.54', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '35.76', 'spread': '4.06', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '30.97', 'spread': '6.39', 'groupId': 'OG000'}, {'value': '35.71', 'spread': '4.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Levels of perfectionism from baseline to post treatment (2 weeks)', 'description': 'Self-report questionnaire examining levels of perfectionism. The concern over mistakes sub-scale of the Frost Multidimensional Perfectionism Scale includes 9 items with scores on the sub-scale ranging from 9 to 45 (higher scores signify higher levels of concern over mistakes). The concern over mistakes sub-scale includes the following items from the Frost Multidimensional Perfectionism Scale: 9, 10, 13, 14, 18, 21, 23, 25, 24. Item scores are summed for a total sub-scale score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiological Studies Depression Scale (CES-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'OG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.26', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '22.97', 'spread': '12.75', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '14.69', 'spread': '8.12', 'groupId': 'OG000'}, {'value': '23.77', 'spread': '11.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Depression symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'OG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.33', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '43.95', 'spread': '12.90', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '39.19', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '43.95', 'spread': '11.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Anxiety symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Phobia Inventory (SPIN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'OG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '29.15', 'spread': '13.08', 'groupId': 'OG000'}, {'value': '30.08', 'spread': '17.12', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '26.58', 'spread': '12.79', 'groupId': 'OG000'}, {'value': '32.31', 'spread': '16.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Social anxiety symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Eating Attitudes Test (EAT-26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'OG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.82', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '12.03', 'spread': '9.63', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '12.05', 'spread': '9.46', 'groupId': 'OG000'}, {'value': '14.34', 'spread': '11.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eating disorder symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report scale that measures eating disorder symptoms. Scores range from 0 to 78 with higher scores indicating higher levels of eating disorder symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Obsessive-Compulsive Inventory- Revised (OCI-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'OG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.89', 'spread': '13.18', 'groupId': 'OG000'}, {'value': '26.68', 'spread': '13.67', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '21.34', 'spread': '13.95', 'groupId': 'OG000'}, {'value': '25.54', 'spread': '13.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Obsessive-compulsiveness from baseline to post treatment (2 weeks)', 'description': 'Self-report scale that measures obsessive-compulsiveness. Scores range from 0 to 72 with higher scores indicating higher levels of obsessive-compulsiveness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'FG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).\n\nExposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.'}, {'id': 'BG001', 'title': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.10', 'spread': '6.09', 'groupId': 'BG000'}, {'value': '18.89', 'spread': '1.31', 'groupId': 'BG001'}, {'value': '19.91', 'spread': '4.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-28', 'size': 251435, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-17T15:36', 'hasProtocol': True}]}}, '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': '2019-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2020-08-03', 'resultsFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-25', 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale', 'timeFrame': 'Levels of perfectionism from baseline to post treatment (2 weeks)', 'description': 'Self-report questionnaire examining levels of perfectionism. The concern over mistakes sub-scale of the Frost Multidimensional Perfectionism Scale includes 9 items with scores on the sub-scale ranging from 9 to 45 (higher scores signify higher levels of concern over mistakes). The concern over mistakes sub-scale includes the following items from the Frost Multidimensional Perfectionism Scale: 9, 10, 13, 14, 18, 21, 23, 25, 24. Item scores are summed for a total sub-scale score.'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiological Studies Depression Scale (CES-D)', 'timeFrame': 'Depression symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.'}, {'measure': 'State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)', 'timeFrame': 'Anxiety symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.'}, {'measure': 'Social Phobia Inventory (SPIN)', 'timeFrame': 'Social anxiety symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.'}, {'measure': 'Eating Attitudes Test (EAT-26)', 'timeFrame': 'Eating disorder symptoms from baseline to post treatment (2 weeks)', 'description': 'Self-report scale that measures eating disorder symptoms. Scores range from 0 to 78 with higher scores indicating higher levels of eating disorder symptoms.'}, {'measure': 'Obsessive-Compulsive Inventory- Revised (OCI-R)', 'timeFrame': 'Obsessive-compulsiveness from baseline to post treatment (2 weeks)', 'description': 'Self-report scale that measures obsessive-compulsiveness. Scores range from 0 to 72 with higher scores indicating higher levels of obsessive-compulsiveness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perfectionism']}, 'descriptionModule': {'briefSummary': 'This study is examining the efficacy of a computerized, exposure-based, intervention for perfectionism.', 'detailedDescription': 'The primary aim of this study is to evaluate the effects of a two-week computerized exposure-based treatment for perfectionism (ETP). Individuals with elevated perfectionism will be randomly assigned to ETP or a waitlist (WL) control condition. ETP will consist of three tasks in which they will repeatedly make mistakes, repeated for five sessions over a two-week period (one session every 3 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Score of at least 29 on the Frost Multidimensional Perfectionism Scale- Concern over Mistakes subscale\n\nExclusion Criteria:\n\n* Current moderate or severe substance use disorder, psychotic disorder, or bipolar disorder\n* Current suicidal ideation (imminent risk)\n* Currently participating in psychotherapy\n* Any changes to psychotropic medications in the past four weeks'}, 'identificationModule': {'nctId': 'NCT04500457', 'briefTitle': 'Exposure-Based Treatment for Perfectionism', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'A Preliminary Evaluation of an Exposure-Based Treatment for Perfectionism', 'orgStudyIdInfo': {'id': 'HSC2019.27351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).', 'interventionNames': ['Behavioral: Exposure-based Treatment for Perfectionism (ETP)']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-List Control', 'description': 'Participants in this condition will not receive treatment.'}], 'interventions': [{'name': 'Exposure-based Treatment for Perfectionism (ETP)', 'type': 'BEHAVIORAL', 'description': 'Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32306', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida State University, Department of Psychology', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychology', 'investigatorFullName': 'Jesse Cougle', 'investigatorAffiliation': 'Florida State University'}}}}