Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04038567
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2019-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Optimizing a Mobile Mindfulness Intervention for ICU Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christopher.cox@duke.edu', 'phone': '919-681-7232', 'title': 'Christopher Cox', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': "Adverse events:\n\n1. death\n2. hospitalization for any reason\n3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')", 'eventGroups': [{'id': 'EG000', 'title': 'App Introduction to Intervention, High Dose, and Therapist Response', 'description': 'Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Therapist Introduction to Intervention, High Dose, and Therapist Response', 'description': 'Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'App Introduction to Intervention, Standard Dose, and Therapist Response', 'description': 'Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Therapist Introduction to Intervention, Standard Dose, and Therapist Response', 'description': 'Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 1, 'seriousNumAtRisk': 32, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'App Introduction to Intervention, High Dose, and App Response', 'description': 'Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 1, 'seriousNumAtRisk': 32, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Therapist Introduction to Intervention, High Dose, and App Response', 'description': 'Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'App Introduction to Intervention, Standard Dose, and App Response', 'description': 'Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Therapist Introduction to Intervention, Standard Dose, and App Response', 'description': 'Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Suicidal ideation (per PHQ-9 item 9)', 'notes': "Anyone responding to PHQ-9 item 9 with a response other than '0' to question regarding suicidal ideation. This survey was done 5-6 times on every participant during the trial, so it is a sum of all these events.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Health Questionnaire-9 Item Scale (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '5.3', 'groupId': 'OG004'}, {'value': '6.4', 'spread': '4.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '1.20', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-2.39', 'ciUpperLimit': '-0.04', 'groupDescription': 'Values are change in model-estimated means for his vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '1.23', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 month post-randomization', 'description': 'Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder 7-item Scale (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '4.3', 'groupId': 'OG003'}, {'value': '5.1', 'spread': '4.7', 'groupId': 'OG004'}, {'value': '5.3', 'spread': '5.1', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '-0.16', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '1.49', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '1.49', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline 1 month post-randomization', 'description': 'Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire-9 Item Scale (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response to Symptoms', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response to Symptoms', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.28', 'spread': '5.76', 'groupId': 'OG000'}, {'value': '7.04', 'spread': '5.50', 'groupId': 'OG001'}, {'value': '8.12', 'spread': '6.23', 'groupId': 'OG002'}, {'value': '6.10', 'spread': '4.65', 'groupId': 'OG003'}, {'value': '6.73', 'spread': '5.69', 'groupId': 'OG004'}, {'value': '7.55', 'spread': '5.53', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '1.01', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.47', 'ciLowerLimit': '-2.81', 'ciUpperLimit': '-0.14', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '2.15', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response to symptoms. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder 7-item Scale (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.62', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '5.69', 'spread': '5.28', 'groupId': 'OG001'}, {'value': '6.83', 'spread': '5.74', 'groupId': 'OG002'}, {'value': '4.38', 'spread': '4.12', 'groupId': 'OG003'}, {'value': '6.25', 'spread': '5.45', 'groupId': 'OG004'}, {'value': '5.11', 'spread': '4.86', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.91', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-2.29', 'ciUpperLimit': '-0.15', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '0.37', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Post-Traumatic Stress Symptom Inventory (PTSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.94', 'spread': '23.88', 'groupId': 'OG000'}, {'value': '27.83', 'spread': '15.10', 'groupId': 'OG001'}, {'value': '31.75', 'spread': '24.05', 'groupId': 'OG002'}, {'value': '25.67', 'spread': '13.05', 'groupId': 'OG003'}, {'value': '29.75', 'spread': '23.95', 'groupId': 'OG004'}, {'value': '27.99', 'spread': '14.89', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-4.41', 'ciUpperLimit': '1.25', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-3.26', 'ciUpperLimit': '2.42', 'groupDescription': 'Values are change in model-estimated means for hig vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '-1.35', 'ciUpperLimit': '4.33', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Intervention Adherence: Activity in App During Final Week of Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}, {'value': '123', 'groupId': 'OG004'}, {'value': '124', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '111', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month post-randomization', 'description': 'Quantified by number with activity (or not) in app during final week (4) of intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intervention Adherence: Number of Views of Content', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}, {'value': '123', 'groupId': 'OG004'}, {'value': '124', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.24', 'spread': '31.37', 'groupId': 'OG000'}, {'value': '40.03', 'spread': '35.82', 'groupId': 'OG001'}, {'value': '34.88', 'spread': '35.81', 'groupId': 'OG002'}, {'value': '39.38', 'spread': '31.38', 'groupId': 'OG003'}, {'value': '40.53', 'spread': '38.31', 'groupId': 'OG004'}, {'value': '33.70', 'spread': '28.14', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month post-randomization', 'description': 'Quantified by mean (SD) number of intervention content (audio, video, text) views', 'unitOfMeasure': 'mobile app content views', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Client Satisfaction Questionnaire (CSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response to Symptoms', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response to Symptoms', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'timeFrame': '3 months post-randomization', 'description': 'A measure of acceptability. Scores can range from 8 (worst) to 32 (best)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'SECONDARY', 'title': 'Systems Usability Scale (SUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response to Symptoms', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response to Symptoms', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'timeFrame': '3 months post-randomization', 'description': 'A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score.\n\nFor each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'SECONDARY', 'title': 'Mindful Attention Awareness Scale (MAAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.41', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '23.49', 'spread': '5.61', 'groupId': 'OG001'}, {'value': '22.86', 'spread': '5.06', 'groupId': 'OG002'}, {'value': '24.04', 'spread': '5.71', 'groupId': 'OG003'}, {'value': '23.31', 'spread': '5.67', 'groupId': 'OG004'}, {'value': '23.59', 'spread': '5.18', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '1.78', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '1.92', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '1.39', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'This is the absolute value, not change score. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Mindful Attention Awareness Scale (MAAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.43', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '23.03', 'spread': '6.17', 'groupId': 'OG001'}, {'value': '22.43', 'spread': '5.79', 'groupId': 'OG002'}, {'value': '23.08', 'spread': '5.94', 'groupId': 'OG003'}, {'value': '22.57', 'spread': '6.23', 'groupId': 'OG004'}, {'value': '22.90', 'spread': '5.51', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '2.27', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '1.38', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.72', 'ciUpperLimit': '0.99', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'These are absolute values, not change scores. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire 10-item Scale (PHQ-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.50', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '6.19', 'spread': '3.45', 'groupId': 'OG001'}, {'value': '6.66', 'spread': '3.44', 'groupId': 'OG002'}, {'value': '6.02', 'spread': '3.16', 'groupId': 'OG003'}, {'value': '6.31', 'spread': '3.32', 'groupId': 'OG004'}, {'value': '6.37', 'spread': '3.32', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '0.30', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '0.27', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-.55', 'ciUpperLimit': '1.05', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'These are absolute values, not change scores. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire 10-item Scale (PHQ-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.21', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '5.63', 'spread': '3.72', 'groupId': 'OG001'}, {'value': '6.15', 'spread': '3.86', 'groupId': 'OG002'}, {'value': '5.64', 'spread': '3.28', 'groupId': 'OG003'}, {'value': '5.85', 'spread': '3.58', 'groupId': 'OG004'}, {'value': '5.96', 'spread': '3.62', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '0.41', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '0.55', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '1.42', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'This is an absolute value, not a change score. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'EuroQOL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.56', 'spread': '23.07', 'groupId': 'OG000'}, {'value': '63.60', 'spread': '21.25', 'groupId': 'OG001'}, {'value': '58.87', 'spread': '21.98', 'groupId': 'OG002'}, {'value': '66.56', 'spread': '21.64', 'groupId': 'OG003'}, {'value': '63.91', 'spread': '21.43', 'groupId': 'OG004'}, {'value': '61.43', 'spread': '22.75', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '-3.25', 'ciUpperLimit': '7.91', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.82', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '10.40', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-5.60', 'ciUpperLimit': '5.56', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'This is an absolute, not change, value. the EuroQOL is a measure of quality of life. Scores can range from 0 (worst) to 100 (best)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Change in EuroQOL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.07', 'spread': '22.23', 'groupId': 'OG000'}, {'value': '65.47', 'spread': '24.44', 'groupId': 'OG001'}, {'value': '61.68', 'spread': '24.15', 'groupId': 'OG002'}, {'value': '66.21', 'spread': '22.48', 'groupId': 'OG003'}, {'value': '65.02', 'spread': '24.87', 'groupId': 'OG004'}, {'value': '62.74', 'spread': '22.03', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.18', 'ciLowerLimit': '-3.01', 'ciUpperLimit': '9.37', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '-4.92', 'ciUpperLimit': '7.47', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-6.09', 'ciUpperLimit': '6.30', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'A measure of quality of life. Scores can range from 0 (worst) to 100 (best)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Distress Associated With Depression Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'timeFrame': 'Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED', 'description': 'A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Distress Associated With Depression Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.22', 'spread': '28.53', 'groupId': 'OG000'}, {'value': '37.40', 'spread': '26.65', 'groupId': 'OG001'}, {'value': '44.26', 'spread': '28.96', 'groupId': 'OG002'}, {'value': '34.02', 'spread': '25.14', 'groupId': 'OG003'}, {'value': '41.34', 'spread': '28.36', 'groupId': 'OG004'}, {'value': '37.25', 'spread': '26.78', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 month post-randomization', 'description': 'A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distress Associated With Anxiety Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}, {'value': '123', 'groupId': 'OG004'}, {'value': '124', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.31', 'spread': '26.50', 'groupId': 'OG000'}, {'value': '49.54', 'spread': '25.04', 'groupId': 'OG001'}, {'value': '50.11', 'spread': '26.07', 'groupId': 'OG002'}, {'value': '44.67', 'spread': '25.38', 'groupId': 'OG003'}, {'value': '48.57', 'spread': '24.47', 'groupId': 'OG004'}, {'value': '46.24', 'spread': '27.15', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 month post-randomization', 'description': 'A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distress Associated With Anxiety Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}], 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Distress Associated With PTSD Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}, {'value': '123', 'groupId': 'OG004'}, {'value': '124', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.60', 'spread': '30.52', 'groupId': 'OG000'}, {'value': '47.04', 'spread': '29.04', 'groupId': 'OG001'}, {'value': '49.56', 'spread': '28.59', 'groupId': 'OG002'}, {'value': '42.02', 'spread': '30.54', 'groupId': 'OG003'}, {'value': '47.69', 'spread': '28.63', 'groupId': 'OG004'}, {'value': '43.94', 'spread': '30.84', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 month post-randomization', 'description': 'A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distress Associated With PTSD Symptom Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'timeFrame': 'At 3 months post-randomization', 'description': 'Absolute values, not change scores. A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Post-Traumatic Stress Symptom Inventory (PTSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.91', 'spread': '28.14', 'groupId': 'OG000'}, {'value': '26.38', 'spread': '13.08', 'groupId': 'OG001'}, {'value': '31.53', 'spread': '28.04', 'groupId': 'OG002'}, {'value': '23.65', 'spread': '11.04', 'groupId': 'OG003'}, {'value': '29.53', 'spread': '27.81', 'groupId': 'OG004'}, {'value': '25.77', 'spread': '13.36', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.70', 'ciLowerLimit': '-5.26', 'ciUpperLimit': '-0.13', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.89', 'ciLowerLimit': '-4.46', 'ciUpperLimit': '0.67', 'groupDescription': 'Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-3.31', 'ciUpperLimit': '1.83', 'groupDescription': 'Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \\[1\\] vs app \\[-1\\]), dose (high \\[1\\] vs low \\[-1\\]), and symptom management (therapist \\[1\\] vs app \\[-1\\]).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'Absolute values, not change scores. Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data collected at both time points.'}, {'type': 'SECONDARY', 'title': 'Client Satisfaction Questionnaire (CSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.27', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '25.31', 'spread': '4.82', 'groupId': 'OG001'}, {'value': '24.86', 'spread': '5.11', 'groupId': 'OG002'}, {'value': '25.71', 'spread': '4.10', 'groupId': 'OG003'}, {'value': '25.81', 'spread': '4.58', 'groupId': 'OG004'}, {'value': '24.79', 'spread': '4.67', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month post-randomization', 'description': 'A measure of acceptability. Scores can range from 8 (worst) to 32 (best)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systems Usability Scale (SUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'App Introduction to Intervention', 'description': 'Introduction to intervention via the mobile app itself.'}, {'id': 'OG001', 'title': 'Therapist Introduction to Intervention', 'description': 'Introduction to intervention via a call from the study therapist.'}, {'id': 'OG002', 'title': 'Standard Dose', 'description': 'Standard dose of meditation time (once a day).'}, {'id': 'OG003', 'title': 'High Dose', 'description': 'High dose of meditation time (twice a day).'}, {'id': 'OG004', 'title': 'App Response to Symptoms', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'OG005', 'title': 'Therapist Response to Symptoms', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.'}], 'timeFrame': '1 month post-randomization', 'description': 'A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score.\n\nFor each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'App Introduction to Intervention, High Dose, and Therapist Response', 'description': 'Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'FG001', 'title': 'Therapist Introduction to Intervention, High Dose, and Therapist Response', 'description': 'Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'FG002', 'title': 'App Introduction to Intervention, Standard Dose, and Therapist Response', 'description': 'Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'FG003', 'title': 'Therapist Introduction to Intervention, Standard Dose, and Therapist Response', 'description': 'Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'FG004', 'title': 'App Introduction to Intervention, High Dose, and App Response', 'description': 'Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'FG005', 'title': 'Therapist Introduction to Intervention, High Dose, and App Response', 'description': 'Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'FG006', 'title': 'App Introduction to Intervention, Standard Dose, and App Response', 'description': 'Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'FG007', 'title': 'Therapist Introduction to Intervention, Standard Dose, and App Response', 'description': 'Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '24'}, {'groupId': 'FG006', 'numSubjects': '22'}, {'groupId': 'FG007', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'missed survey window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'technical issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Medical issues (i.e., illness)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Note that this is a factorial experimental trial in which 3 factors were examined, each at 2 levels (i.e., a 2\\^3 design).\n\nIn this trial the 3 factors and 2 levels are as follows:\n\n1. Introduction to intervention (app introduction vs. therapist introduction)\n2. Dose (standard vs. high)\n3. Response to depression symptoms that increase during the intervention period (app response vs. therapist response)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '247', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'App Introduction to Intervention, High Dose, and Therapist Response', 'description': 'Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG001', 'title': 'Therapist Introduction to Intervention, High Dose, and Therapist Response', 'description': 'Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG002', 'title': 'App Introduction to Intervention, Standard Dose, and Therapist Response', 'description': 'Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG003', 'title': 'Therapist Introduction to Intervention, Standard Dose, and Therapist Response', 'description': 'Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG004', 'title': 'App Introduction to Intervention, High Dose, and App Response', 'description': 'Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG005', 'title': 'Therapist Introduction to Intervention, High Dose, and App Response', 'description': 'Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG006', 'title': 'App Introduction to Intervention, Standard Dose, and App Response', 'description': 'Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG007', 'title': 'Therapist Introduction to Intervention, Standard Dose, and App Response', 'description': 'Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '15.7', 'groupId': 'BG002'}, {'value': '48.8', 'spread': '14.8', 'groupId': 'BG003'}, {'value': '47.4', 'spread': '16.4', 'groupId': 'BG004'}, {'value': '49.4', 'spread': '17.1', 'groupId': 'BG005'}, {'value': '51.3', 'spread': '14.4', 'groupId': 'BG006'}, {'value': '49.4', 'spread': '15.2', 'groupId': 'BG007'}, {'value': '50.22', 'spread': '15.38', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '104', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '143', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 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'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '35', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '179', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '247', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-22', 'size': 817301, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-15T10:33', 'hasProtocol': True}, {'date': '2023-11-28', 'size': 623610, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-07T10:39', 'hasProtocol': False}, {'date': '2021-07-19', 'size': 223433, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-27T12:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'PIs and analysts blinded to allocation. Outcomes completed by participants using web-based interface and thus outcomes assessors as such are blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2019-07-24', 'resultsFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-23', 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 Item Scale (PHQ-9)', 'timeFrame': '1 month post-randomization', 'description': 'Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)'}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder 7-item Scale (GAD-7)', 'timeFrame': 'Between baseline 1 month post-randomization', 'description': 'Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)'}, {'measure': 'Patient Health Questionnaire-9 Item Scale (PHQ-9)', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)'}, {'measure': 'Generalized Anxiety Disorder 7-item Scale (GAD-7)', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)'}, {'measure': 'Post-Traumatic Stress Symptom Inventory (PTSS)', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst).'}, {'measure': 'Intervention Adherence: Activity in App During Final Week of Intervention', 'timeFrame': '1 month post-randomization', 'description': 'Quantified by number with activity (or not) in app during final week (4) of intervention'}, {'measure': 'Intervention Adherence: Number of Views of Content', 'timeFrame': '1 month post-randomization', 'description': 'Quantified by mean (SD) number of intervention content (audio, video, text) views'}, {'measure': 'Client Satisfaction Questionnaire (CSQ)', 'timeFrame': '3 months post-randomization', 'description': 'A measure of acceptability. Scores can range from 8 (worst) to 32 (best)'}, {'measure': 'Systems Usability Scale (SUS)', 'timeFrame': '3 months post-randomization', 'description': 'A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score.\n\nFor each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)'}, {'measure': 'Mindful Attention Awareness Scale (MAAS)', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'This is the absolute value, not change score. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).'}, {'measure': 'Mindful Attention Awareness Scale (MAAS)', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'These are absolute values, not change scores. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).'}, {'measure': 'Patient Health Questionnaire 10-item Scale (PHQ-10)', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'These are absolute values, not change scores. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).'}, {'measure': 'Patient Health Questionnaire 10-item Scale (PHQ-10)', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'This is an absolute value, not a change score. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).'}, {'measure': 'EuroQOL Scale', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'This is an absolute, not change, value. the EuroQOL is a measure of quality of life. Scores can range from 0 (worst) to 100 (best)'}, {'measure': 'Change in EuroQOL Scale', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'A measure of quality of life. Scores can range from 0 (worst) to 100 (best)'}, {'measure': 'Distress Associated With Depression Symptom Frequency', 'timeFrame': 'Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED', 'description': 'A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)'}, {'measure': 'Distress Associated With Depression Symptom Frequency', 'timeFrame': 'At 1 month post-randomization', 'description': 'A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)'}, {'measure': 'Distress Associated With Anxiety Symptom Frequency', 'timeFrame': 'At 1 month post-randomization', 'description': 'A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)'}, {'measure': 'Distress Associated With Anxiety Symptom Frequency', 'timeFrame': 'Between baseline 3 months post-randomization', 'description': 'A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)'}, {'measure': 'Distress Associated With PTSD Symptom Frequency', 'timeFrame': 'At 1 month post-randomization', 'description': 'A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)'}, {'measure': 'Distress Associated With PTSD Symptom Frequency', 'timeFrame': 'At 3 months post-randomization', 'description': 'Absolute values, not change scores. A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)'}, {'measure': 'Post-Traumatic Stress Symptom Inventory (PTSS)', 'timeFrame': 'Between baseline and 1 month post-randomization', 'description': 'Absolute values, not change scores. Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).'}, {'measure': 'Client Satisfaction Questionnaire (CSQ)', 'timeFrame': '1 month post-randomization', 'description': 'A measure of acceptability. Scores can range from 8 (worst) to 32 (best)'}, {'measure': 'Systems Usability Scale (SUS)', 'timeFrame': '1 month post-randomization', 'description': 'A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score.\n\nFor each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiorespiratory failure', 'critical illness', 'psychological distress', 'depression', 'anxiety', 'post-traumatic stress disorder', 'intensive care units', 'adults', 'mechanical ventilation'], 'conditions': ['Cardiorespiratory Failure']}, 'referencesModule': {'references': [{'pmid': '24303911', 'type': 'BACKGROUND', 'citation': 'Cox CE, Porter LS, Buck PJ, Hoffa M, Jones D, Walton B, Hough CL, Greeson JM. Development and preliminary evaluation of a telephone-based mindfulness training intervention for survivors of critical illness. Ann Am Thorac Soc. 2014 Feb;11(2):173-81. doi: 10.1513/AnnalsATS.201308-283OC.'}, {'pmid': '29793970', 'type': 'BACKGROUND', 'citation': 'Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.'}, {'pmid': '32805434', 'type': 'BACKGROUND', 'citation': "Cox CE, Olsen MK, Gallis JA, Porter LS, Greeson JM, Gremore T, Frear A, Ungar A, McKeehan J, McDowell B, McDaniel H, Moss M, Hough CL. Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial. Contemp Clin Trials. 2020 Sep;96:106119. doi: 10.1016/j.cct.2020.106119. Epub 2020 Aug 15."}, {'pmid': '38805199', 'type': 'DERIVED', 'citation': 'Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.'}]}, 'descriptionModule': {'briefSummary': 'This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. This will allow optimization of a mobile mindfulness intervention by comparing eight different iterations across domains including impact on symptoms, feasibility, acceptability, usability, scalability, and cost.', 'detailedDescription': "As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, an innovative app-based mobile mindfulness training program twas developed hat promotes automated care delivery and self-management of symptom-related distress.\n\nSubsequently, a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. Key findings were that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology.\n\nTo address these gaps, this 5-year project is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. It will optimize mobile mindfulness with four specific aims as described in the following sections. At the conclusion of this factorial randomized clinical trial study involving 240 cardiorespiratory failure survivors, a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact will be delivered that will be off-the-shelf ready for a next-step definitive RCT-and can serve as a model for distance-based mind and body interventions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA\n\n1. Adult (age ≥18)\n2. Acute cardiorespiratory failure:\n\n * Acute respiratory failure, defined as ≥1 of the following:\n * mechanical ventilation via endotracheal tube for ≥12 hours\n * non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)\n * high flow nasal cannula or face mask oxygen for ≥4 hours in a 24-hour period and / or\n * Acute cardiac / circulatory failure, defined as ≥1 of the following:\n * use of vasopressors for shock of any etiology for ≥1 hour\n * use of inotropes for shock of any etiology for ≥1 hour\n * use of pulmonary vascular vasoactive medications\n * use of aortic balloon pump for cardiogenic shock for ≥1 hour\n3. Managed in an adult medical cardiac, trauma, surgical, or neurological ICU, stepdown unit, or monitored ward unit for ≥24 hours during the time inclusion criterion #2 is met.\n4. Cognitive status intact\n\n * No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart\n * Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen)\n * Decisional capacity present\n5. Absence of severe and/or persistent mental illness\n\n * Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \\[as per medical record\\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission\n * No endorsement of suicidality at time of admission or informed consent\n * No active substance abuse within the 3 months preceding the current admission serious enough to limit completion of study procedures in the opinion of the site investigator.\n6. English fluency.\n\nEXCLUSION CRITERIA (in hospital):\n\n1. Hospitalized within the preceding 3 months with life-threatening illness or injury.\n\n Patients may be enrolled into the study if they had a hospitalization within the preceding 3 months that is determined to be non-serious. Non-serious admissions are defined as those admissions that are non-life threatening and/or potentially impacting patient's well-being long-term or likely to precipitate additional future admissions. Examples of non-life-threatening hospitalizations could be, but may not be limited to, admission for a bronchoscopy, admission for deep vein thrombosis, or admission to ED resulting in overnight stay for cardiac work-up.\n2. Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)\n3. Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)\n4. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)\n5. Unable to complete study procedures as determined by staff\n6. Lack of reliable smartphone with cellular data plan or wifi access\n\n EXCLUSION CRITERIA (at T1, post-discharge):\n7. Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score \\<5\n8. Failure to randomize within 2 month (60 days) post-discharge."}, 'identificationModule': {'nctId': 'NCT04038567', 'acronym': 'LIFT2', 'briefTitle': 'Optimizing a Mobile Mindfulness Intervention for ICU Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': "Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress", 'orgStudyIdInfo': {'id': 'Pro00100252'}, 'secondaryIdInfos': [{'id': '1U01AT009974', 'link': 'https://reporter.nih.gov/quickSearch/1U01AT009974', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'App introduction to intervention', 'description': 'Introduction to intervention via the mobile app itself.', 'interventionNames': ['Behavioral: Mobile mindfulness-based training']}, {'type': 'OTHER', 'label': 'Therapist introduction to intervention', 'description': 'Introduction to intervention via a call from the study therapist.', 'interventionNames': ['Behavioral: Mobile mindfulness-based training']}, {'type': 'OTHER', 'label': 'Standard dose', 'description': 'Standard dose of meditation time (once a day).', 'interventionNames': ['Behavioral: Mobile mindfulness-based training']}, {'type': 'OTHER', 'label': 'High dose', 'description': 'High dose of meditation time (twice a day).', 'interventionNames': ['Behavioral: Mobile mindfulness-based training']}, {'type': 'OTHER', 'label': 'App response to symptoms', 'description': 'Mobile app response to elevated psychological distress symptoms during intervention period.', 'interventionNames': ['Behavioral: Mobile mindfulness-based training']}, {'type': 'OTHER', 'label': 'Therapist response to symptoms', 'description': 'Therapist call in response to elevated psychological distress symptoms during intervention period.', 'interventionNames': ['Behavioral: Mobile mindfulness-based training']}], 'interventions': [{'name': 'Mobile mindfulness-based training', 'type': 'BEHAVIORAL', 'description': 'The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 6 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.', 'armGroupLabels': ['App introduction to intervention', 'App response to symptoms', 'High dose', 'Standard dose', 'Therapist introduction to intervention', 'Therapist response to symptoms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Christopher E Cox, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'We will follow NIH and institutional guidelines.', 'ipdSharing': 'YES', 'description': 'We will follow NIH/NCCIH guidelines for data access.', 'accessCriteria': 'We will follow NIH and institutional guidelines. Given the length of time that will elapse during the study, we will need to adhere to the rules present at that time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}