Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 9:30 PM
Study NCT ID:
NCT05090995
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2021-10-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lisa.fucito@yale.edu', 'phone': '203-200-1470', 'title': 'Lisa Fucito, PhD', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Drinks Consumed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.76', 'spread': '.26', 'groupId': 'OG000'}, {'value': '7.07', 'spread': '.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to Week 10', 'description': 'Total drinks consumed will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many drinks they consume each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater number of drinks consumed. Total drinks will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks over time with condition, time, and their interaction in the model and sex and baseline total drinks as covariates.', 'unitOfMeasure': 'drinks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either treatment condition.'}, {'type': 'SECONDARY', 'title': 'Drinks Per Drinking Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.26', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 10 weeks', 'description': 'Total drinks per drinking day will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. Total drinks/drinking day will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks/drinking day over time with condition, time, and their interaction in the model and sex and baseline drinks per drinking day as covariates.\n\nThis tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by the amount of self-reported alcohol consumption that occurred each day. A heavy drinking day for a man would be ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting.', 'unitOfMeasure': 'drinks per drinking day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either condition.'}, {'type': 'SECONDARY', 'title': 'Percent Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.62', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '19.83', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 10 weeks', 'description': 'Self-reported percent heavy drinking days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report heavy drinking occasions over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10, defined as ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting. Higher scores indicate a greater percentage of heavy drinking days. The percentage of heavy drinking days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent heavy drinking days over time with condition, time, and their interaction in the model and sex and baseline percent heavy drinking days as covariates.', 'unitOfMeasure': 'percentage of heavy drinking days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either treatment condition.'}, {'type': 'SECONDARY', 'title': 'Percent Abstinent Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.04', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '65.56', 'spread': '1.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 10 weeks', 'description': 'Self-reported percent abstinent days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many days they did not consume any alcohol each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater percentage of abstinent days. The percentage of abstinent days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent abstinent days over time with condition, time, and their interaction in the model and sex and baseline percent abstinent days as covariates.', 'unitOfMeasure': 'percentage of abstinent days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either treatment condition.'}, {'type': 'SECONDARY', 'title': 'Alcohol-related Consequences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.56', 'spread': '.75', 'groupId': 'OG000'}, {'value': '8.23', 'spread': '.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For baseline consequences', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For effects with time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, Week 6, and Week 10', 'description': 'Mean alcohol related consequences were measured using the Brief Young Adult Alcohol Consequences Questionnaire at baseline, Week 6, and Week 10. Each consequence is scored 1 point and a total score reflects the total number of consequences. Higher scores indicated more consequences.Total score range 0-24. The three timepoints are summed then averaged. Mixed effects models were then conducted to evaluate the effect of condition on consequences over time with condition, time, and their interaction in the model and sex and baseline consequences as covariates.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either treatment condition.'}, {'type': 'SECONDARY', 'title': 'Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.59', 'spread': '.93', 'groupId': 'OG000'}, {'value': '50.38', 'spread': '.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and Week 10', 'description': 'Mean sleep quality will be measured using the PROMIS - Sleep Disturbance Form 8 assessment. The sleep disturbance assessment has 8 questions that yield a total score (summed scores). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences worse sleep quality. Mixed effects models were then conducted to evaluate the effect of condition on sleep quality over time with condition, time, and their interaction in the model and sex and baseline sleep quality as covariates.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either condition.'}, {'type': 'SECONDARY', 'title': 'Sleep-related Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.98', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '55.05', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effect of baseline sleep scores', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For effects with time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and Week 10', 'description': 'Mean sleep quality will be measured using the PROMIS - Sleep-Related Impairment Form 8 assessment. The sleep impairment assessment has 8 questions that yield a total score (summed score). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more sleep-related impairment. Mixed effects models were then conducted to evaluate the effect of condition on sleep-related impairment over time with condition, time, and their interaction in the model and sex and baseline sleep-related impairment as covariates.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either condition.'}, {'type': 'SECONDARY', 'title': 'Sleep Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'title': 'Weeks 1-2', 'categories': [{'measurements': [{'value': '168.73', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '170.78', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3-4', 'categories': [{'measurements': [{'value': '172.18', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '169.38', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 5-6', 'categories': [{'measurements': [{'value': '171.74', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '170.11', 'spread': '1.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For interaction between treatment group and time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Main effects of sex', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Main effects of type of day of the week (weekday vs. weekend)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 6 weeks', 'description': 'Mean sleep duration will be measured daily for 6 weeks by the PPG device. Sleep duration will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a square-root transformation.', 'unitOfMeasure': 'square root in milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either condition.'}, {'type': 'SECONDARY', 'title': 'Heart Rate Variability (HRV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'title': 'Weeks 1-2', 'categories': [{'measurements': [{'value': '7.55', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '7.79', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3-4', 'categories': [{'measurements': [{'value': '7.63', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '7.81', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 5-6', 'categories': [{'measurements': [{'value': '7.68', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '7.84', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Main effect of day of the week.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 6 weeks', 'description': 'Heart rate variability (HRV) will be measured daily for 6 weeks by the PPG device. HRV will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either treatment condition.'}, {'type': 'SECONDARY', 'title': 'Lowest Resting Heart Rate (RHR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily mobile diaries, and the provision of personalized health feedback and advice.'}, {'id': 'OG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily mobile diaries.'}], 'classes': [{'title': 'Weeks 1-2', 'categories': [{'measurements': [{'value': '4.06', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3-4', 'categories': [{'measurements': [{'value': '4.06', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 5-6', 'categories': [{'measurements': [{'value': '4.05', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For interaction between treatment condition and time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Main effects of sex', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Main effects of type of day of the week (weekday vs. weekend)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 6 weeks', 'description': 'Lowest Resting Heart Rate (RHR) will be measured daily for 6 weeks by the PPG device. The lowest value will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation. RHR can vary anywhere between 40-100 beats per minute. Lower RHR would indicate better cardiovascular health.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started either treatment condition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.'}, {'id': 'FG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Completed Week 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Completed Week 10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.\n\nBehavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.'}, {'id': 'BG001', 'title': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time.\n\nBehavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.33', 'spread': '1.83', 'groupId': 'BG000'}, {'value': '21.71', 'spread': '2.13', 'groupId': 'BG001'}, {'value': '22.02', 'spread': '1.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Nonbinary', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-11', 'size': 401482, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-21T16:08', 'hasProtocol': True}, {'date': '2022-01-27', 'size': 172688, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-13T18:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible subjects will be randomized into either the Assessment or Feedback group. Subjects in the assessment group will not receive personalized health feedback or advice on their health behaviors. They will wear a consumer- level PPG device daily and complete electronic diaries about bedtime behavior and sleep from the previous night for six weeks. Subjects in the feedback group will also wear a consumer-level PPG device and complete diaries each morning for six weeks. Subjects in this group will monitor their health behaviors and receive personalized feedback and advice. Subjects will also be able to receive daily information regarding their health behaviors from the PPG device application. At weeks two, four, and six subjects will will receive written reports that summarize their alcohol usage and the links made between their drinking and health outcomes from the PPG application results. Subjects will also receive advice on how to improve health behaviors.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2021-10-11', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-18', 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Drinks Consumed', 'timeFrame': 'up to Week 10', 'description': 'Total drinks consumed will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many drinks they consume each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater number of drinks consumed. Total drinks will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks over time with condition, time, and their interaction in the model and sex and baseline total drinks as covariates.'}], 'secondaryOutcomes': [{'measure': 'Drinks Per Drinking Day', 'timeFrame': 'up to 10 weeks', 'description': 'Total drinks per drinking day will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. Total drinks/drinking day will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks/drinking day over time with condition, time, and their interaction in the model and sex and baseline drinks per drinking day as covariates.\n\nThis tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by the amount of self-reported alcohol consumption that occurred each day. A heavy drinking day for a man would be ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting.'}, {'measure': 'Percent Heavy Drinking Days', 'timeFrame': 'up to 10 weeks', 'description': 'Self-reported percent heavy drinking days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report heavy drinking occasions over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10, defined as ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting. Higher scores indicate a greater percentage of heavy drinking days. The percentage of heavy drinking days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent heavy drinking days over time with condition, time, and their interaction in the model and sex and baseline percent heavy drinking days as covariates.'}, {'measure': 'Percent Abstinent Days', 'timeFrame': 'up to 10 weeks', 'description': 'Self-reported percent abstinent days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many days they did not consume any alcohol each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater percentage of abstinent days. The percentage of abstinent days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent abstinent days over time with condition, time, and their interaction in the model and sex and baseline percent abstinent days as covariates.'}, {'measure': 'Alcohol-related Consequences', 'timeFrame': 'baseline, Week 6, and Week 10', 'description': 'Mean alcohol related consequences were measured using the Brief Young Adult Alcohol Consequences Questionnaire at baseline, Week 6, and Week 10. Each consequence is scored 1 point and a total score reflects the total number of consequences. Higher scores indicated more consequences.Total score range 0-24. The three timepoints are summed then averaged. Mixed effects models were then conducted to evaluate the effect of condition on consequences over time with condition, time, and their interaction in the model and sex and baseline consequences as covariates.'}, {'measure': 'Sleep Quality', 'timeFrame': 'baseline and Week 10', 'description': 'Mean sleep quality will be measured using the PROMIS - Sleep Disturbance Form 8 assessment. The sleep disturbance assessment has 8 questions that yield a total score (summed scores). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences worse sleep quality. Mixed effects models were then conducted to evaluate the effect of condition on sleep quality over time with condition, time, and their interaction in the model and sex and baseline sleep quality as covariates.'}, {'measure': 'Sleep-related Impairment', 'timeFrame': 'baseline and Week 10', 'description': 'Mean sleep quality will be measured using the PROMIS - Sleep-Related Impairment Form 8 assessment. The sleep impairment assessment has 8 questions that yield a total score (summed score). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more sleep-related impairment. Mixed effects models were then conducted to evaluate the effect of condition on sleep-related impairment over time with condition, time, and their interaction in the model and sex and baseline sleep-related impairment as covariates.'}, {'measure': 'Sleep Duration', 'timeFrame': 'up to 6 weeks', 'description': 'Mean sleep duration will be measured daily for 6 weeks by the PPG device. Sleep duration will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a square-root transformation.'}, {'measure': 'Heart Rate Variability (HRV)', 'timeFrame': 'up to 6 weeks', 'description': 'Heart rate variability (HRV) will be measured daily for 6 weeks by the PPG device. HRV will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation.'}, {'measure': 'Lowest Resting Heart Rate (RHR)', 'timeFrame': 'up to 6 weeks', 'description': 'Lowest Resting Heart Rate (RHR) will be measured daily for 6 weeks by the PPG device. The lowest value will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation. RHR can vary anywhere between 40-100 beats per minute. Lower RHR would indicate better cardiovascular health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heavy Drinking', 'Harmful; Use, Alcohol']}, 'referencesModule': {'references': [{'pmid': '23584812', 'type': 'BACKGROUND', 'citation': 'Falk D, Yi HY, Hiller-Sturmhofel S. An epidemiologic analysis of co-occurring alcohol and drug use and disorders: findings from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC). Alcohol Res Health. 2008;31(2):100-10.'}, {'type': 'BACKGROUND', 'citation': 'Administration, S.A.a.M.H.S. Key substance use and mental health indicators in the United States: Results from the National Survey on Drug Use and Health, Center for Behavioral Health Statistics and Quality. 2019; Available from: https://www.samhsa.gov/data/.'}, {'pmid': '19538908', 'type': 'BACKGROUND', 'citation': 'Hingson RW, Zha W, Weitzman ER. 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This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.', 'detailedDescription': 'Proposed is a study to conduct the first controlled test of a feedback intervention targeting heart rate variability, resting heart rate, and sleep for heavy-drinking young adults (N=60; ages 18-25) and will leverage the capabilities of a consumer-marketed PPG sensor/mobile app. This study will evaluate the feasibility, acceptability, and preliminary efficacy of this intervention for promoting improvements in drinking, sleep, and health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-25 years of age\n* Report ≥ 4 heavy drinking occasions in the past 28 days\n* Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm\n* English Speaking\n* Have a personal smartphone\n\nExclusion Criteria:\n\n* Sleep Disorder History\n* Night/ Rotating work shift\n* Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation\n* Clinically severe AUD in past 12 months\n* Currently enrolled in alcohol or sleep treatment\n* Current, severe psychiatric illness\n* Current DSM-V substance use disorder\n* Positive urine drug screen for a substance other than marijuana'}, 'identificationModule': {'nctId': 'NCT05090995', 'briefTitle': 'A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Photoplethysmography Sensor-based Personalized Feedback Intervention for Heavy-drinking Young Adults Targeting Heart Rate Variability, Resting Heart Rate, and Sleep', 'orgStudyIdInfo': {'id': '2000030417'}, 'secondaryIdInfos': [{'id': '1R21AA028886-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21AA028886-01A1', 'type': 'NIH'}, {'id': '21-002981', 'type': 'OTHER_GRANT', 'domain': 'PI Assigned ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Self-Monitoring and Feedback', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.', 'interventionNames': ['Behavioral: Behavioral Self-Management and Feedback']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Self-Monitoring', 'description': 'The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time.', 'interventionNames': ['Behavioral: Behavioral Self-Management']}], 'interventions': [{'name': 'Behavioral Self-Management and Feedback', 'type': 'BEHAVIORAL', 'description': 'Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.', 'armGroupLabels': ['Self-Monitoring and Feedback']}, {'name': 'Behavioral Self-Management', 'type': 'BEHAVIORAL', 'description': 'Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.', 'armGroupLabels': ['Self-Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Lisa Fucito, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}