Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-27 @ 12:36 PM
Study NCT ID:
NCT05356533
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2022-04-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coping Skills for Alcohol Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cadiganj@uw.edu', 'phone': '206-543-5689', 'title': 'Jennifer Cadigan', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data was collected over a 4 month period.', 'description': 'The definition of adverse event and serious adverse event does not differ from the clinicialtrials.gov definition', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alcohol Use-Peak Drinks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'OG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.71', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.08', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'past month', 'description': 'Peak number of drinks; Item measuring peak alcohol consumption, "Think of the occasion you drank the most this past month. How much did you drink?", response options ranged from 0 (0 drinks) to 25 (25+ drinks);', 'unitOfMeasure': 'number of drinks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alcohol Use-drinks Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'OG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.40', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '6.09', 'spread': '6.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'past month', 'description': 'The DDQ (Collins, Parks, \\& Marlatt, 1985) was used to measure the quantity of alcohol consumed by asking participants to estimate the typical number of drinks consumed on each day of the week, on average during the past month. A sum score of weekly total drinks per week was then calculated as the sum of the total number of drinks per week reported.', 'unitOfMeasure': 'drinks per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alcohol Use-heavy Episodic Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'OG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.69', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.81', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'past month', 'description': 'Heavy Episodic Drinking; NIAAA item assessing binge drinking, "During the past month, how often did you have \\[4 or more drinks (for women) /5 or more drinks (for men)\\] containing any kind of alcohol within a two-hour period?", response options ranged from 0 (Never) to 7 (Every day);', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alcohol Negative Consequences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'OG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.79', 'spread': '4.70', 'groupId': 'OG000'}, {'value': '4.64', 'spread': '5.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.91', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Past Month', 'description': 'Alcohol Negative Consequences, Sum score (count) of negative consequences taken from Brief Young Adult Alcohol Consequences Questionnaire; Scores ranged from 0-24, with higher scores associated with more consequences.', 'unitOfMeasure': 'number of consequences', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alcohol Coping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'OG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.99', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Past Month', 'description': "The Drinking Motives Questionnaire-Revised (DMQR; Grant V.V., Stewart S.H., O'Connor R.M., Backwell E., \\& Conrod P.J. (2007). Psychometric evaluation of the five-factor Modified Drinking Motives Questionnaire-Revised in undergraduates. Addictive Behaviors, 32(11), 2611-2632. Doi: 10.1016/j.addbeh.2007.07.004 ) was used to assess reasons for drinking. Using a 5-point scale (ranging from 'almost never/never' to 'almost always/always' participants rate how frequently they use alcohol for various reasons. The alcohol coping motives subscale was used which takes the average of the 9 items on the coping-depression subscale. Average scores ranged from 1-5, with higher scores are associated with greater use of coping.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'OG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.98', 'spread': '5.31', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '5.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Past month', 'description': 'depressive symptoms; The eight-item Patient Health Questionnaire depression scale (PHQ-8) was used to assess for symptoms of depression. A sum of the 8 items was used, with the summed score ranging from 0-24. Higher scores represent greater symptoms of depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'FG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.\n\nDrinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills'}, {'id': 'BG001', 'title': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}, {'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': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', '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': '21.76', 'spread': '2.095', 'groupId': 'BG000'}, {'value': '21.84', 'spread': '2.154', 'groupId': 'BG001'}, {'value': '21.80', 'spread': '2.117', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-22', 'size': 972789, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-22T14:29', 'hasProtocol': True}, {'date': '2024-09-08', 'size': 98230, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-08T17:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-08', 'studyFirstSubmitDate': '2022-04-27', 'resultsFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-08', 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Use-Peak Drinks', 'timeFrame': 'past month', 'description': 'Peak number of drinks; Item measuring peak alcohol consumption, "Think of the occasion you drank the most this past month. How much did you drink?", response options ranged from 0 (0 drinks) to 25 (25+ drinks);'}, {'measure': 'Alcohol Use-drinks Per Week', 'timeFrame': 'past month', 'description': 'The DDQ (Collins, Parks, \\& Marlatt, 1985) was used to measure the quantity of alcohol consumed by asking participants to estimate the typical number of drinks consumed on each day of the week, on average during the past month. A sum score of weekly total drinks per week was then calculated as the sum of the total number of drinks per week reported.'}, {'measure': 'Alcohol Use-heavy Episodic Drinking', 'timeFrame': 'past month', 'description': 'Heavy Episodic Drinking; NIAAA item assessing binge drinking, "During the past month, how often did you have \\[4 or more drinks (for women) /5 or more drinks (for men)\\] containing any kind of alcohol within a two-hour period?", response options ranged from 0 (Never) to 7 (Every day);'}, {'measure': 'Alcohol Negative Consequences', 'timeFrame': 'Past Month', 'description': 'Alcohol Negative Consequences, Sum score (count) of negative consequences taken from Brief Young Adult Alcohol Consequences Questionnaire; Scores ranged from 0-24, with higher scores associated with more consequences.'}, {'measure': 'Alcohol Coping', 'timeFrame': 'Past Month', 'description': "The Drinking Motives Questionnaire-Revised (DMQR; Grant V.V., Stewart S.H., O'Connor R.M., Backwell E., \\& Conrod P.J. (2007). Psychometric evaluation of the five-factor Modified Drinking Motives Questionnaire-Revised in undergraduates. Addictive Behaviors, 32(11), 2611-2632. Doi: 10.1016/j.addbeh.2007.07.004 ) was used to assess reasons for drinking. Using a 5-point scale (ranging from 'almost never/never' to 'almost always/always' participants rate how frequently they use alcohol for various reasons. The alcohol coping motives subscale was used which takes the average of the 9 items on the coping-depression subscale. Average scores ranged from 1-5, with higher scores are associated with greater use of coping."}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': 'Past month', 'description': 'depressive symptoms; The eight-item Patient Health Questionnaire depression scale (PHQ-8) was used to assess for symptoms of depression. A sum of the 8 items was used, with the summed score ranging from 0-24. Higher scores represent greater symptoms of depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking', 'Coping Skills']}, 'descriptionModule': {'briefSummary': 'A total of 120 young adults who drink to cope with negative affect will be randomized to a 4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60) or an assessment only control (n=60). Participants will complete 4 weekly assessments and a 1- and 3-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Eligibility criteria at recruitment include: 1)18-25 years old; 2) Currently live in the state of WA, 3) Have a valid email address and phone number, 4) Drank alcohol at least once in the past month, 5) report at least 1 alcohol-related problem in the past month, 6) report using alcohol to cope with distress via negative reinforcement (i.e., to provide relief or reduction of stress or depressed mood) in the past month\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05356533', 'briefTitle': 'Coping Skills for Alcohol Use', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Development of an Interactive, Web-based Drinking to Cope Intervention and Tools to Assess Coping Skill Utilization', 'orgStudyIdInfo': {'id': 'STUDY00008998'}, 'secondaryIdInfos': [{'id': '1R34AA028074', 'link': 'https://reporter.nih.gov/quickSearch/1R34AA028074', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.', 'interventionNames': ['Behavioral: Drinking to Cope CBT skills']}, {'type': 'NO_INTERVENTION', 'label': 'Assessment Control', 'description': 'A total of 60 young adults will be randomized to the assessment only control condition.'}], 'interventions': [{'name': 'Drinking to Cope CBT skills', 'type': 'BEHAVIORAL', 'description': 'Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jennifer M Cadigan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, School of Medicine: Psychiatry', 'investigatorFullName': 'Jennifer Cadigan', 'investigatorAffiliation': 'University of Washington'}}}}