Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT03955250
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2019-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mobile After-Care Support App: Pilot RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000682', 'term': 'Amyloid'}], 'ancestors': [{'id': 'D046912', 'term': 'Multiprotein Complexes'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BGaudiano@Butler.org', 'phone': '401-455-6457', 'title': 'Brandon Gaudiano, Ph.D.', 'organization': 'Butler Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a pilot RCT and therefore was designed to assess feasibility and acceptability of the intervention in preparation for a larger clinical trial. It was not powered to test comparative efficacy.'}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Mobile After-Care Support (MACS) App', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.\n\nMobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Mobile App Attention Control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.\n\nMobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'Rehospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Client Satisfaction Questionnaire (CSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile After-Care Support (MACS) App', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.\n\nMobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.'}, {'id': 'OG001', 'title': 'Mobile App Attention Control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.\n\nMobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is lower than the number enrolled due to missing data on this measure.'}, {'type': 'SECONDARY', 'title': 'Brief Psychiatric Rating Scale (BPRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile After-Care Support (MACS) App', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.\n\nMobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.'}, {'id': 'OG001', 'title': 'Mobile App Attention Control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.\n\nMobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '53.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': '4 Month', 'categories': [{'measurements': [{'value': '36.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'time'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'condition'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 month', 'description': 'The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was intent-to-treat based on all participants initially enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Brief Adherence Rating Scale (BARS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile After-Care Support (MACS) App', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.\n\nMobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.'}, {'id': 'OG001', 'title': 'Mobile App Attention Control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.\n\nMobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '83.8', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': '4 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.4', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '92.0', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'time'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'condition'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 month', 'description': 'The Brief Adherence Rating Scale assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was intent-to-treat based on all participants initially enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Brief Cope Inventory (Brief COPE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile After-Care Support (MACS) App', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.\n\nMobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.'}, {'id': 'OG001', 'title': 'Mobile App Attention Control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.\n\nMobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '28.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '4 Month', 'categories': [{'measurements': [{'value': '24.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'time'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'condition'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 month', 'description': 'The Brief Cope Inventory is a 28 item self-report measure of coping skills. The mean values of the 12-item dysfunctional coping subscale was used. Mean scores for the total range from 1-48 with higher scores indicating greater use of the dysfunctional coping strategies.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was intent-to-treat based on all participants initially enrolled in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobile After-Care Support (MACS) App', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.\n\nMobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.'}, {'id': 'FG001', 'title': 'Mobile App Attention Control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.\n\nMobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobile After-Care Support (MACS) App', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.\n\nMobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.'}, {'id': 'BG001', 'title': 'Mobile App Attention Control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.\n\nMobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '35.1', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-14', 'size': 434071, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-29T15:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2019-05-16', 'resultsFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-01', 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Client Satisfaction Questionnaire (CSQ)', 'timeFrame': '1 month', 'description': 'The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.'}], 'secondaryOutcomes': [{'measure': 'Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': 'Baseline, 4 month', 'description': 'The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.'}, {'measure': 'Brief Adherence Rating Scale (BARS)', 'timeFrame': 'Baseline, 4 month', 'description': 'The Brief Adherence Rating Scale assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.'}, {'measure': 'Brief Cope Inventory (Brief COPE)', 'timeFrame': 'Baseline, 4 month', 'description': 'The Brief Cope Inventory is a 28 item self-report measure of coping skills. The mean values of the 12-item dysfunctional coping subscale was used. Mean scores for the total range from 1-48 with higher scores indicating greater use of the dysfunctional coping strategies.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'psychosis', 'mHealth', 'psychiatric hospitalization', 'treatment adherence', 'transitions of care', 'coping skills', 'psychosocial intervention'], 'conditions': ['Psychotic Disorder']}, 'referencesModule': {'references': [{'pmid': '38842850', 'type': 'DERIVED', 'citation': 'Gaudiano BA, Ward M, Benz MB, Hughes C, Johnson JE, Moitra E. Feasibility and acceptability of a mobile intervention for patients with psychosis following psychiatric hospitalization: A pilot randomized controlled trial. Psychol Serv. 2025 May;22(2):221-231. doi: 10.1037/ser0000869. Epub 2024 Jun 6.'}]}, 'descriptionModule': {'briefSummary': "The overall aim of this program of research is to refine and test the feasibility and acceptability of a newly developed mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder. The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of the app. To achieve the specific aims, the investigators will conduct a pilot randomized clinical trial (n = 60), with two treatment arms: MACS vs. a mobile app attention control condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recently hospitalized\n* DSM-5 criteria for psychotic-spectrum disorder based on structured clinical interview\n* 18 years or older\n* prescribed antipsychotic medication upon discharge\n* ability to speak and read English\n\nExclusion Criteria:\n\n* substance use disorders at severe level\n* planned discharge to supervised living setting or participation in formal outpatient adherence programs\n* pregnancy or other medical condition contraindicating use of antipsychotic medications'}, 'identificationModule': {'nctId': 'NCT03955250', 'acronym': 'MACS-RCT', 'briefTitle': 'Mobile After-Care Support App: Pilot RCT', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization: Pilot RCT', 'orgStudyIdInfo': {'id': '1905-001'}, 'secondaryIdInfos': [{'id': 'R34MH115144', 'link': 'https://reporter.nih.gov/quickSearch/R34MH115144', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile After-Care Support (MACS) app', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.', 'interventionNames': ['Behavioral: Mobile After-Care Support (MACS) app']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mobile app attention control', 'description': 'All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.', 'interventionNames': ['Behavioral: Mobile app attention control']}], 'interventions': [{'name': 'Mobile After-Care Support (MACS) app', 'type': 'BEHAVIORAL', 'description': 'The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.', 'armGroupLabels': ['Mobile After-Care Support (MACS) app']}, {'name': 'Mobile app attention control', 'type': 'BEHAVIORAL', 'description': 'The control app provides ecological momentary assessment and psychoeducation about illness.', 'armGroupLabels': ['Mobile app attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02916', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Brandon Gaudiano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}, {'name': 'Ethan Moitra, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Uploaded to NIMH Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}