Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-29 @ 11:10 AM
Study NCT ID:
NCT04342494
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Providing Mental Health Precision Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amybohne@med.umich.edu', 'phone': '(734) 936-4280', 'title': 'Amy Bohnert', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.', 'otherNumAtRisk': 690, 'deathsNumAtRisk': 690, 'otherNumAffected': 0, 'seriousNumAtRisk': 690, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.', 'otherNumAtRisk': 349, 'deathsNumAtRisk': 349, 'otherNumAffected': 0, 'seriousNumAtRisk': 349, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.', 'otherNumAtRisk': 349, 'deathsNumAtRisk': 349, 'otherNumAffected': 0, 'seriousNumAtRisk': 349, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.', 'otherNumAtRisk': 345, 'deathsNumAtRisk': 345, 'otherNumAffected': 0, 'seriousNumAtRisk': 345, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.', 'otherNumAtRisk': 346, 'deathsNumAtRisk': 346, 'otherNumAffected': 0, 'seriousNumAtRisk': 346, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'OG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'OG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '13.0', 'spread': '6.2', 'groupId': 'OG003'}, {'value': '12.8', 'spread': '6.4', 'groupId': 'OG004'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '311', 'groupId': 'OG003'}, {'value': '310', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '10.1', 'spread': '5.9', 'groupId': 'OG002'}, {'value': '10.3', 'spread': '5.9', 'groupId': 'OG003'}, {'value': '10.6', 'spread': '5.7', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Symptom-level change estimates were adjusted for baseline PHQ-9 score via analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 weeks', 'description': 'The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present."}, {'type': 'SECONDARY', 'title': 'Mood as Measured by the Mental Health App Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '344', 'groupId': 'OG002'}, {'value': '340', 'groupId': 'OG003'}, {'value': '341', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'OG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'OG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '5.9', 'spread': '1.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0073', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Average mood score obtained from daily measurements analyzed via analysis of variance'}], 'paramType': 'MEAN', 'timeFrame': 'Daily up to 6 weeks', 'description': 'Participants were asked a single question, "On a scale of 1 to 10, what was your average mood today?" Scores were averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed their mood scores between weeks 2 and 6 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'OG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'OG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '5.1', 'groupId': 'OG002'}, {'value': '18.2', 'spread': '4.9', 'groupId': 'OG003'}, {'value': '17.8', 'spread': '5.3', 'groupId': 'OG004'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '311', 'groupId': 'OG003'}, {'value': '310', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '5.1', 'groupId': 'OG002'}, {'value': '18.8', 'spread': '4.9', 'groupId': 'OG003'}, {'value': '18.2', 'spread': '5.3', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Symptom-level change estimates were adjusted for baseline PANSI-PI score via analysis of covariance'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 weeks', 'description': 'The PANSI-PI subscale consisted of 6 items. The possible total scores on the PANSI-PI subscale ranged from 6 to 30. Lower scores on the PANSI-PI reflected greater risk for suicidal behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present."}, {'type': 'SECONDARY', 'title': 'Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'OG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'OG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.1', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '11.6', 'spread': '6.8', 'groupId': 'OG003'}, {'value': '11.7', 'spread': '6.3', 'groupId': 'OG004'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '311', 'groupId': 'OG003'}, {'value': '310', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '10.8', 'spread': '5.5', 'groupId': 'OG002'}, {'value': '10.5', 'spread': '5.5', 'groupId': 'OG003'}, {'value': '10.6', 'spread': '5.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Symptom-level change estimates were adjusted for baseline PANSI-NSI score via analysis of covariance'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 weeks', 'description': 'The PANSI-NSI subscale was composed of 8 items. The possible total score on the PANSI-NSI ranged from 8 to 40. Higher scores on the PANSI-NSI reflected greater risk for suicidal behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present."}, {'type': 'SECONDARY', 'title': 'Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'OG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'OG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '11.4', 'spread': '5.9', 'groupId': 'OG002'}, {'value': '11.9', 'spread': '6.0', 'groupId': 'OG003'}, {'value': '11.8', 'spread': '5.8', 'groupId': 'OG004'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '311', 'groupId': 'OG003'}, {'value': '311', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '5.7', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '5.6', 'groupId': 'OG003'}, {'value': '9.8', 'spread': '5.7', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Symptom-level change estimates were adjusted for baseline GAD-7 score via analysis of covariance'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 weeks', 'description': 'GAD-7 consisted of the total score for seven items ranging from 0 to 21. Scores of 5, 10, and 15 represented cut points for mild, moderate, and severe anxiety, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present."}, {'type': 'SECONDARY', 'title': 'Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'OG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'OG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'OG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}, {'value': '345', 'groupId': 'OG003'}, {'value': '346', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '560', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}, {'value': '287', 'groupId': 'OG003'}, {'value': '285', 'groupId': 'OG004'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '311', 'groupId': 'OG003'}, {'value': '311', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '255', 'groupId': 'OG003'}, {'value': '247', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 weeks', 'description': 'The ASSIST Global Continuum of Illicit Drug Risk Score ranged from 0 to 308, with higher scores indicating greater risk. Results reflect the participants who indicated they had consumed any alcohol, smoked, or used an illicit substance when asked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'FG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'FG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'FG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'FG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '690'}, {'groupId': 'FG001', 'numSubjects': '349'}, {'groupId': 'FG002', 'numSubjects': '349'}, {'groupId': 'FG003', 'numSubjects': '345'}, {'groupId': 'FG004', 'numSubjects': '346'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '640'}, {'groupId': 'FG001', 'numSubjects': '311'}, {'groupId': 'FG002', 'numSubjects': '313'}, {'groupId': 'FG003', 'numSubjects': '311'}, {'groupId': 'FG004', 'numSubjects': '310'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Questionnaire partially completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '35'}]}]}], 'preAssignmentDetails': '2118 participants were consented for this trial. Of that number, 2079 completed baseline and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}, {'value': '346', 'groupId': 'BG004'}, {'value': '2079', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.\n\nEnhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.'}, {'id': 'BG001', 'title': 'Headspace App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nHeadspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'BG002', 'title': 'Headspace App + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.\n\nHeadspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.'}, {'id': 'BG003', 'title': 'SilverCloud App + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.\n\nSilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'BG004', 'title': 'SilverCloud App +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.\n\nSilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '36.8', 'spread': '14.5', 'groupId': 'BG002'}, {'value': '36.8', 'spread': '13.7', 'groupId': 'BG003'}, {'value': '36.5', 'spread': '14.3', 'groupId': 'BG004'}, {'value': '36.8', 'spread': '14.3', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '560', 'groupId': 'BG005'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '491', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}, {'value': '248', 'groupId': 'BG004'}, {'value': '1499', 'groupId': 'BG005'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '142', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '641', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}, {'value': '328', 'groupId': 'BG004'}, {'value': '1920', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '118', 'groupId': 'BG005'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '162', 'groupId': 'BG005'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}, {'value': '271', 'groupId': 'BG004'}, {'value': '1590', 'groupId': 'BG005'}]}]}, {'title': 'Multiple races', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '690', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}, {'value': '346', 'groupId': 'BG004'}, {'value': '2079', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Orientation', 'classes': [{'title': 'Heterosexual', 'categories': [{'measurements': [{'value': '495', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}, {'value': '236', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}, {'value': '1448', 'groupId': 'BG005'}]}]}, {'title': 'Bisexual', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '301', 'groupId': 'BG005'}]}]}, {'title': 'Gay or lesbian', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}]}, {'title': 'Multiple identities', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'title': 'Full-time', 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}, {'value': '825', 'groupId': 'BG005'}]}]}, {'title': 'Part-time', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '399', 'groupId': 'BG005'}]}]}, {'title': 'Retired', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '139', 'groupId': 'BG005'}]}]}, {'title': 'Student', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '278', 'groupId': 'BG005'}]}]}, {'title': 'Unemployed', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '435', 'groupId': 'BG005'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Educational Level', 'classes': [{'title': '<High school diploma', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}]}, {'title': 'High school diploma or GED', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '225', 'groupId': 'BG005'}]}]}, {'title': 'Some College', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '519', 'groupId': 'BG005'}]}]}, {'title': 'Associate degree or TVS', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '261', 'groupId': 'BG005'}]}]}, {'title': "Bachelor's degree", 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}, {'value': '564', 'groupId': 'BG005'}]}]}, {'title': "≥Master's degree", 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '458', 'groupId': 'BG005'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender Identity', 'classes': [{'title': 'Man', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}, {'value': '539', 'groupId': 'BG005'}]}]}, {'title': 'Woman', 'categories': [{'measurements': [{'value': '466', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}, {'value': '236', 'groupId': 'BG004'}, {'value': '1423', 'groupId': 'BG005'}]}]}, {'title': 'Transgender and Nonbinary (TGNB)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '106', 'groupId': 'BG005'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-23', 'size': 315470, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-14T14:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2020-04-08', 'resultsFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-27', 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': 'Up to 6 weeks', 'description': 'The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression.'}], 'secondaryOutcomes': [{'measure': 'Mood as Measured by the Mental Health App Assessment', 'timeFrame': 'Daily up to 6 weeks', 'description': 'Participants were asked a single question, "On a scale of 1 to 10, what was your average mood today?" Scores were averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods.'}, {'measure': 'Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)', 'timeFrame': 'Up to 6 weeks', 'description': 'The PANSI-PI subscale consisted of 6 items. The possible total scores on the PANSI-PI subscale ranged from 6 to 30. Lower scores on the PANSI-PI reflected greater risk for suicidal behavior.'}, {'measure': 'Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)', 'timeFrame': 'Up to 6 weeks', 'description': 'The PANSI-NSI subscale was composed of 8 items. The possible total score on the PANSI-NSI ranged from 8 to 40. Higher scores on the PANSI-NSI reflected greater risk for suicidal behavior.'}, {'measure': 'Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale', 'timeFrame': 'Up to 6 weeks', 'description': 'GAD-7 consisted of the total score for seven items ranging from 0 to 21. Scores of 5, 10, and 15 represented cut points for mild, moderate, and severe anxiety, respectively.'}, {'measure': 'Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)', 'timeFrame': 'Up to 6 weeks', 'description': 'The ASSIST Global Continuum of Illicit Drug Risk Score ranged from 0 to 308, with higher scores indicating greater risk. Results reflect the participants who indicated they had consumed any alcohol, smoked, or used an illicit substance when asked.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Behavioral health', 'Precision health'], 'conditions': ['Depression', 'Addiction', 'Anxiety', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '39023893', 'type': 'DERIVED', 'citation': 'Horwitz AG, Mills ED, Sen S, Bohnert ASB. Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422115. doi: 10.1001/jamanetworkopen.2024.22115.'}]}, 'descriptionModule': {'briefSummary': 'This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments, and to understand which patients receive the most benefit.', 'detailedDescription': 'Initially, results-reporting was planned for 12-month data. However, following 6-week data collection, the participants received other care, so the decision was made to report on the 6-week data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a scheduled mental health intake appointment at Michigan Medicine Outpatient Psychiatry or University Health Service at the University of Michigan\n* Must have daily access to a smartphone version that is compatible with study activity trackers.\n* Understands English to enable consent and use of the MyDataHelps app and app-based interventions\n* Provide complete, updated contact information upon enrollment to the study\n* Agree to be contacted by study staff during the study\n* Willingness to keep study setup (devices, apps, settings) in required configuration for the duration of the study, and following instructions by study staff if required to update or re-achieve required configuration if required configuration has been lost (e.g., change of phone, app deletion)\n\nExclusion Criteria:\n\n* Self-reported or medical record indication of a current eating disorder\n* Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)\n* Wrist too large or too small to wear an Apple Watch or Fitbit comfortably (Note: bands that are shorter or longer than the standard will be made available to minimize this exclusion)'}, 'identificationModule': {'nctId': 'NCT04342494', 'acronym': 'PROMPT', 'briefTitle': 'Providing Mental Health Precision Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Providing Mental Health Precision Treatment', 'orgStudyIdInfo': {'id': 'HUM00164162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.', 'interventionNames': ['Behavioral: Enhanced Feedback + Standard Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Headspace app + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.', 'interventionNames': ['Device: Headspace app + Standard Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Headspace app + Enhanced Feedback + Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.', 'interventionNames': ['Device: Headspace app + Enhanced Feedback + Standard Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'SilverCloud app + Standard Feedback', 'description': 'Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.', 'interventionNames': ['Device: SilverCloud + Standard Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'SilverCloud app +Enhanced Feedback +Standard Feedback', 'description': 'Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.', 'interventionNames': ['Device: SilverCloud app +Enhanced Feedback +Standard Feedback']}], 'interventions': [{'name': 'Enhanced Feedback + Standard Feedback', 'type': 'BEHAVIORAL', 'description': 'Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.', 'armGroupLabels': ['Enhanced Feedback + Standard Feedback']}, {'name': 'Headspace app + Standard Feedback', 'type': 'DEVICE', 'description': 'Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nHeadspace is an app designed to train the user in mindfulness practices.', 'armGroupLabels': ['Headspace app + Standard Feedback']}, {'name': 'Headspace app + Enhanced Feedback + Standard Feedback', 'type': 'DEVICE', 'description': 'Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nHeadspace is an app designed to train the user in mindfulness practices.', 'armGroupLabels': ['Headspace app + Enhanced Feedback + Standard Feedback']}, {'name': 'SilverCloud + Standard Feedback', 'type': 'DEVICE', 'description': 'Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.', 'armGroupLabels': ['SilverCloud app + Standard Feedback']}, {'name': 'SilverCloud app +Enhanced Feedback +Standard Feedback', 'type': 'DEVICE', 'description': 'Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.\n\nEnhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.\n\nSilvercloud is an app designed to deliver cognitive behavioral therapy.', 'armGroupLabels': ['SilverCloud app +Enhanced Feedback +Standard Feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Amy Bohnert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amy S.B. Bohnert', 'investigatorAffiliation': 'University of Michigan'}}}}