Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-30 @ 3:50 AM
Study NCT ID:
NCT03159468
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2017-05-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Emotion Regulation Interventions for Alcohol-Related Sexual Aggression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088686', 'term': 'Cognitive Restructuring'}, {'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kelly.Cue.Davis@asu.edu', 'phone': '602-496-3217', 'title': 'Kelly Cue Davis', 'organization': 'Arizona State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the in-lab study experiment. There was no follow-up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Restructuring & Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive an alcoholic beverage.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mindfulness & Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nutrition Information & Alcohol Condition', 'description': 'Participants will receive general information about nutrition, then receive an alcoholic beverage.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cognitive Restrucuring & No Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive a non-alcoholic beverage.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Mindfulness & No Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Nutrition Information & No Alcohol Condition', 'description': 'Participants will receive general information about nutrition, then receive a non-alcoholic beverage.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sexual Aggression Intentions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Restructuring & Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received an alcoholic beverage in the lab.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.'}, {'id': 'OG001', 'title': 'Mindfulness & Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.'}, {'id': 'OG002', 'title': 'Nutrition Information & Alcohol Condition', 'description': 'Participants received general information about nutrition, then received an alcoholic beverage in the lab.'}, {'id': 'OG003', 'title': 'Cognitive Restructuring & No Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.'}, {'id': 'OG004', 'title': 'Mindfulness & No Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.'}, {'id': 'OG005', 'title': 'Nutrition Information & No Alcohol Condition', 'description': 'Participants received general information about nutrition, then received a non-alcoholic beverage in the lab.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '2.18', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '1.53', 'spread': '1.16', 'groupId': 'OG003'}, {'value': '1.38', 'spread': '.90', 'groupId': 'OG004'}, {'value': '1.70', 'spread': '1.15', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '.041', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'pValueComment': 'This p-value is for the main effect of beverage condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '.160', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'pValueComment': 'This p-value is for the main effect of intervention condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '.462', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'pValueComment': 'This p-value is for the beverage condition by intervention condition interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Within one hour after receiving the intervention', 'description': 'Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Restructuring & Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume an alcoholic beverage in the lab.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.'}, {'id': 'FG001', 'title': 'Mindfulness & Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage in the lab.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.'}, {'id': 'FG002', 'title': 'Nutrition Information & Alcohol Condition', 'description': 'Participants receive general information about nutrition, then receive an alcoholic beverage in the lab.'}, {'id': 'FG003', 'title': 'Cognitive Restructuring & No Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume a non-alcoholic beverage in the lab.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.'}, {'id': 'FG004', 'title': 'Mindfulness & No Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage in the lab.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.'}, {'id': 'FG005', 'title': 'Nutrition Information & No Alcohol Condition', 'description': 'Participants receive general information about nutrition, then receive a non-alcoholic beverage in the lab.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All enrolled participants were assigned to one of the six arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '209', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Restructuring & Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received an alcoholic beverage in the lab.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.'}, {'id': 'BG001', 'title': 'Mindfulness & Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.'}, {'id': 'BG002', 'title': 'Nutrition Information & Alcohol Condition', 'description': 'Participants received general information about nutrition, then received an alcoholic beverage in the lab.'}, {'id': 'BG003', 'title': 'Cognitive Restructuring & No Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.\n\nCognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.'}, {'id': 'BG004', 'title': 'Mindfulness & No Alcohol Condition', 'description': 'Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.\n\nMindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.'}, {'id': 'BG005', 'title': 'Nutrition Information & No Alcohol Condition', 'description': 'Participants received general information about nutrition, then received a non-alcoholic beverage in the lab.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.67', 'spread': '2.88', 'groupId': 'BG000'}, {'value': '24.06', 'spread': '2.78', 'groupId': 'BG001'}, {'value': '25.09', 'spread': '3.03', 'groupId': 'BG002'}, {'value': '25.32', 'spread': '2.58', 'groupId': 'BG003'}, {'value': '24.35', 'spread': '2.60', 'groupId': 'BG004'}, {'value': '25.08', 'spread': '2.68', 'groupId': 'BG005'}, {'value': '24.76', 'spread': '2.77', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '209', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '187', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '125', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '175.29', 'spread': '26.54', 'groupId': 'BG000'}, {'value': '170.34', 'spread': '24.66', 'groupId': 'BG001'}, {'value': '170.26', 'spread': '26.75', 'groupId': 'BG002'}, {'value': '184.09', 'spread': '48.79', 'groupId': 'BG003'}, {'value': '173.53', 'spread': '21.29', 'groupId': 'BG004'}, {'value': '170.97', 'spread': '21.00', 'groupId': 'BG005'}, {'value': '174.07', 'spread': '29.72', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-16', 'size': 75186, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-18T16:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2017-05-12', 'resultsFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-24', 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual Aggression Intentions', 'timeFrame': 'Within one hour after receiving the intervention', 'description': 'Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Aggression', 'Heavy Drinking']}, 'descriptionModule': {'briefSummary': "Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the majority of these assaults. Despite well-intentioned prevention efforts, this pandemic continues unabated, warranting the development of novel and innovative approaches to the reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two brief online emotion regulation interventions for reducing alcohol-related sexual aggression in heavy episodic drinking young men with a sexual aggression history. Previous research suggests that emotion regulation difficulties are associated with both alcohol consumption and aggressive behavior. Despite the potential prevention utility of improving sexually aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual aggression, this approach has yet to be explored. Thus, this study evaluates the effects of two brief online ER interventions - cognitive restructuring and mindfulness - on men's emotion regulation during a sexual aggression-related analogue. Additionally, these effects will be evaluated during both sober and intoxicated states through a laboratory- based alcohol administration experiment."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Self-defined as male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single\n* Male\n* Age 21-30\n* Heterosexually active within past year\n* Heavy episodic drinker\n* Self-reported history of sexual aggression\n\nExclusion Criteria:\n\n* History of alcohol problems\n* Medical condition or medications that contraindicate alcohol consumption'}, 'identificationModule': {'nctId': 'NCT03159468', 'briefTitle': 'Emotion Regulation Interventions for Alcohol-Related Sexual Aggression', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention', 'orgStudyIdInfo': {'id': 'STUDY00002103'}, 'secondaryIdInfos': [{'id': '1R21AA023811-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21AA023811-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Restructuring & Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab.', 'interventionNames': ['Behavioral: Cognitive Restructuring', 'Other: Alcohol consumption']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness & Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab.', 'interventionNames': ['Behavioral: Mindfulness', 'Other: Alcohol consumption']}, {'type': 'EXPERIMENTAL', 'label': 'Nutrition Information & Alcohol Condition', 'description': 'Participants will receive general information about nutrition. They will then consume an alcoholic beverage in the lab.', 'interventionNames': ['Other: Alcohol consumption']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Restructuring & No Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab.', 'interventionNames': ['Behavioral: Cognitive Restructuring']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness & No Alcohol Condition', 'description': 'Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab.', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'NO_INTERVENTION', 'label': 'Nutrition Information & No Alcohol Condition', 'description': 'Participants will receive general information about nutrition. They will then consume a non-alcoholic beverage in the lab.'}], 'interventions': [{'name': 'Cognitive Restructuring', 'type': 'BEHAVIORAL', 'description': 'Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.', 'armGroupLabels': ['Cognitive Restructuring & Alcohol Condition', 'Cognitive Restructuring & No Alcohol Condition']}, {'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.', 'armGroupLabels': ['Mindfulness & Alcohol Condition', 'Mindfulness & No Alcohol Condition']}, {'name': 'Alcohol consumption', 'type': 'OTHER', 'description': 'Participants consume an alcoholic beverage in the lab.', 'armGroupLabels': ['Cognitive Restructuring & Alcohol Condition', 'Mindfulness & Alcohol Condition', 'Nutrition Information & Alcohol Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'Arizona State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kelly Cue Davis', 'investigatorAffiliation': 'University of Washington'}}}}