Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-31 @ 3:24 AM
Study NCT ID:
NCT04013932
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Family Psychoeducation for Adults With Psychotic Disorders in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joy.baumgartner@unc.edu', 'phone': '919.923.8534', 'title': 'Joy Noel Baumgartner', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From baseline to endline data collection (~1 year)', 'description': 'Adverse event data was not collected on caregivers. Death and temporary missing person experiences were identified during follow-up data collection timepoints (review of medical records and contacts with caregivers).', 'eventGroups': [{'id': 'EG000', 'title': 'KUPAA Intervention + Standard of Care', 'description': 'Patients will be assigned to a KUPAA group composed of approximately 6 patients per group (with matched caregivers also attending). Patients first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (\\~1.5-2 hours) for 12 weeks.\n\nKUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:\n\n1-2 Joining sessions \\[\\~30 to 45 minutes each\\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.\n\nEducational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.\n\n12 Family psychoeducation group sessions \\[\\~1.5 hours each session\\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control - Standard of Care', 'description': 'Patients will receive the standard of care.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Patient who left home temporarily/missing (relapse related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patient Participants Who Experience Illness Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KUPAA Intervention + Standard of Care', 'description': 'Patients will be assigned to a KUPAA group composed of approximately 6 patients (who attend with a matched caregiver). Participants first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (\\~1.5-2 hours) for 12 weeks.\n\nKUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:\n\n1-2 Joining sessions \\[\\~30 to 45 minutes each\\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.\n\nEducational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.\n\n12 Family psychoeducation group sessions \\[\\~1.5 hours each session\\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.'}, {'id': 'OG001', 'title': 'Control - Standard of Care', 'description': 'Patients will receive the standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.46'}, {'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '0.64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)', 'description': 'Patient relapse measured by hospitalization or non-hospitalized relapse, defined as a new illness episode with recurrence of symptoms after one month of controlled symptoms.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on two Control participants.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Endline in Disability, as Measured by the World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KUPAA Intervention + Standard of Care', 'description': 'Patients will be assigned to a KUPAA group composed of approximately 6 patients (with their matched caregivers). Patients participated in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (\\~1.5-2 hours) for 12 weeks.\n\nKUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:\n\n1-2 Joining sessions \\[\\~30 to 45 minutes each\\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.\n\nEducational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.\n\n12 Family psychoeducation group sessions \\[\\~1.5 hours each session\\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.'}, {'id': 'OG001', 'title': 'Control - Standard of Care', 'description': 'Patients will receive the standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.89', 'spread': '14.66', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '21.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention) and Endline (~6-7 months post-intervention)', 'description': "Scores are measured from the 36-item WHODAS 2.0, the World Health Organization Disability Assessment Schedule, which measures health and disability. WHODAS 2.0 This self-report assessment measures difficulties performing daily activities over the past 30 days. It consists of 36 Likert-formatted questions across six domains: understanding and communicating, getting around, self-care, getting along with others, life activities, and participation in society. WHO's guidelines for the complex scoring method were used to create the total score, ranging from 0 (no disability) to 100 (full disability). Higher scores indicate worse outcomes.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on five Control participants.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Endline in Quality of Life, as Measured by the World Health Organization Quality of Life- Abbreviated Version (WHOQOL-BREF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KUPAA Intervention + Standard of Care', 'description': 'Patients will be assigned to a KUPAA group composed of approximately 6 patients (with their matched caregivers). Patients will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (\\~1.5-2 hours) for 12 weeks.\n\nKUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:\n\n1-2 Joining sessions \\[\\~30 to 45 minutes each\\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.\n\nEducational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.\n\n12 Family psychoeducation group sessions \\[\\~1.5 hours each session\\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.'}, {'id': 'OG001', 'title': 'Control - Standard of Care', 'description': 'Patients will receive the standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.88', 'spread': '20.98', 'groupId': 'OG000'}, {'value': '77.39', 'spread': '16.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention) and Endline (~6-7 months post-intervention)', 'description': 'Raw total scores are measured from the 26-item WHOQOL-BREF (the abbreviated version of the World Health Organization Quality of Life 100 scale). This self-report assessment has 26 questions across four domains; physical health, psychological, social relationships, and environment. Each item is rated on a five-point Likert scale (1-5) ranging from 1 (not at all, very dissatisfied, very poor) to 5 (an extreme amount, very satisfied, very good); three items needed reverse scoring. The range is 26 (min) to 130 (max) for the total raw score. Higher scores indicate a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on five Control participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KUPAA Intervention + Standard of Care', 'description': 'Patients will be assigned to a KUPAA group composed of approximately 6 patients who will also be joined by their caregivers in their sessions. The patients will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop open to both the patients and their caregivers. Patient-participants will then attend weekly family psychoeducation group sessions (\\~1.5-2 hours) for 12 weeks with their caregiver.\n\nKUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:\n\n1-2 Joining sessions \\[\\~30 to 45 minutes each\\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.\n\nEducational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.\n\n12 Family psychoeducation group sessions \\[\\~1.5 hours each session\\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.'}, {'id': 'FG001', 'title': 'Control - Standard of Care', 'description': 'Patients will receive the standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'At enrollment, all patients had to identify a caregiver for study participation. If the patient was randomized to the intervention arm, the caregiver would participate in the KUPAA groups with the patients. If the patient was randomized to the control arm, there was no interaction with the caregiver beyond standard of care. All data are focused on the patients only for primary outcomes as they are primary unit of analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KUPAA Intervention + Standard of Care', 'description': 'Patients will be assigned to a KUPAA group composed of approximately 6 patients and 6 matched caregivers. The dyads will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (\\~1.5-2 hours) for 12 weeks.\n\nKUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:\n\n1-2 Joining sessions \\[\\~30 to 45 minutes each\\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.\n\nEducational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.\n\n12 Family psychoeducation group sessions \\[\\~1.5 hours each session\\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.'}, {'id': 'BG001', 'title': 'Control - Standard of Care', 'description': 'Patients will receive the standard of care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.64', 'spread': '8.52', 'groupId': 'BG000'}, {'value': '32.45', 'spread': '7.94', 'groupId': 'BG001'}, {'value': '33.05', 'spread': '8.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', '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': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race of participants in Tanzania', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tanzania', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '4 or more years since illness onset', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The primary analysis population is the patients and that is what is reported in the tables (not caregivers). Patients could participate in the intervention arm even if a caregiver stopped attending group sessions. The intervention is focused on patient outcomes (disability, quality of life, and relapse).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-31', 'size': 525639, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-17T15:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Only the main biostatistician will be masked in the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2019-07-08', 'resultsFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-07', 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patient Participants Who Experience Illness Relapse', 'timeFrame': 'Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)', 'description': 'Patient relapse measured by hospitalization or non-hospitalized relapse, defined as a new illness episode with recurrence of symptoms after one month of controlled symptoms.'}, {'measure': 'Change From Baseline to Endline in Disability, as Measured by the World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0)', 'timeFrame': 'Baseline (pre-intervention) and Endline (~6-7 months post-intervention)', 'description': "Scores are measured from the 36-item WHODAS 2.0, the World Health Organization Disability Assessment Schedule, which measures health and disability. WHODAS 2.0 This self-report assessment measures difficulties performing daily activities over the past 30 days. It consists of 36 Likert-formatted questions across six domains: understanding and communicating, getting around, self-care, getting along with others, life activities, and participation in society. WHO's guidelines for the complex scoring method were used to create the total score, ranging from 0 (no disability) to 100 (full disability). Higher scores indicate worse outcomes."}, {'measure': 'Change From Baseline to Endline in Quality of Life, as Measured by the World Health Organization Quality of Life- Abbreviated Version (WHOQOL-BREF)', 'timeFrame': 'Baseline (pre-intervention) and Endline (~6-7 months post-intervention)', 'description': 'Raw total scores are measured from the 26-item WHOQOL-BREF (the abbreviated version of the World Health Organization Quality of Life 100 scale). This self-report assessment has 26 questions across four domains; physical health, psychological, social relationships, and environment. Each item is rated on a five-point Likert scale (1-5) ranging from 1 (not at all, very dissatisfied, very poor) to 5 (an extreme amount, very satisfied, very good); three items needed reverse scoring. The range is 26 (min) to 130 (max) for the total raw score. Higher scores indicate a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Family Psychoeducation', 'Schizophrenia', 'Tanzania', 'Severe and Persistent Mental Illness', 'Culturally tailored'], 'conditions': ['Schizophrenia Spectrum and Other Psychotic Disorders', 'Mental Disorders, Severe']}, 'referencesModule': {'references': [{'pmid': '38889160', 'type': 'DERIVED', 'citation': 'Egger JR, Kaaya S, Swai P, Lawala P, Ndelwa L, Temu J, Bukuku ES, Lukens E, Susser E, Dixon L, Minja A, Clari R, Martinez A, Headley J, Baumgartner JN. Functioning and quality of life among treatment-engaged adults with psychotic disorders in urban Tanzania: Baseline results from the KUPAA clinical trial. PLoS One. 2024 Jun 18;19(6):e0304367. doi: 10.1371/journal.pone.0304367. eCollection 2024.'}, {'pmid': '37442999', 'type': 'DERIVED', 'citation': 'Martinez A, Baumgartner JN, Kaaya S, Swai P, Lawala PS, Thedai B, Minja A, Headley J, Egger JR. Hopefulness among individuals living with schizophrenia and their caregivers in Tanzania: an actor-partner interdependence model. BMC Psychiatry. 2023 Jul 13;23(1):508. doi: 10.1186/s12888-023-04990-8.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to pilot test a culturally tailored Family Psychoeducation model (KUPAA) for adults with psychotic disorders and their relatives that is appropriate for cultural settings inclusive of both traditional and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the intervention.', 'detailedDescription': 'Family psychoeducation (FPE) is an evidence-based practice used in high-income countries to help individuals with psychotic disorders and their relatives to cope more effectively with the illness. FPE has never been tested in a low-resource country nor have the mechanisms of action for this psychosocial intervention been fully identified in any context. The goal of this study is to pilot test a culturally tailored Family Psychoeducation model (called KUPAA) for adults with psychotic disorders and their relatives that is appropriate for cultural settings inclusive of both traditional and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the intervention. Formative research has already been conducted to culturally tailor the model for the Tanzanian context. This pilot study is a small randomized controlled trial (RCT) with 72 patient/relative dyads that will test the KUPAA intervention to a) assess the feasibility and acceptability of the adapted family psychoeducation intervention for 12 weeks, and b) explore its impact on patient relapse, quality of life and disability.\n\nPrimary study objectives\n\n1. To pilot test the KUPAA intervention to explore its impact on patient relapse, quality of life and disability\n\n Secondary study objectives\n2. To elucidate the mechanisms of action for KUPAA (e.g. hopefulness, self-efficacy) and refine the mediation and study outcome measures for a future R01/fully powered clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Attending outpatient psychiatric services at Muhimbili National Hospital (MNH) or Mbeya Zonal Referral Hospital (MZRH).\n* ICD-10 Diagnosis of a non-organic psychotic disorder:\n* F20 Schizophrenia\n* F21 Schizotypal disorder\n* F22 Delusional disorders\n* F25 Schizoaffective disorders\n* Age 18-50 at the time of informed consent\n* Hospitalization or relapse (confirmed by attending psychiatrist or medical officer) within the past 12 months.\n\nPatient Exclusion Criteria:\n\n* F23 Brief psychotic disorder\n* F28 Other psychotic disorder not due to a substance or known physiological condition\n* F29 Unspecified psychosis not due to a substance or known physiological condition\n* Epileptic psychoses\n* Bipolar disorder and mania\n* Co-morbid developmental disorder, dementia, or other severe cognitive deficit that renders the individual unable to provided informed consent.\n\nCaregiver Inclusion Criteria:\n\n* Age 18 or older at time of consenting process\n* Patient agrees that this person can be their paired partner for KUPAA if the pair is randomized to the intervention group'}, 'identificationModule': {'nctId': 'NCT04013932', 'briefTitle': 'Family Psychoeducation for Adults With Psychotic Disorders in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Family Psychoeducation for Adults With Psychotic Disorders in Tanzania (Pilot Clinical Trial of KUPAA)', 'orgStudyIdInfo': {'id': 'Pro00094163'}, 'secondaryIdInfos': [{'id': '5R34MH106663', 'link': 'https://reporter.nih.gov/quickSearch/5R34MH106663', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KUPAA Intervention + Standard of Care', 'description': 'Patients will be assigned to a KUPAA group composed of approximately 6 patients (joined by their 6 matched caregivers). Patients will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (\\~1.5-2 hours) for 12 weeks.', 'interventionNames': ['Behavioral: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)']}, {'type': 'NO_INTERVENTION', 'label': 'Control - Standard of Care', 'description': 'Patients will receive the standard of care.'}], 'interventions': [{'name': 'KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)', 'type': 'BEHAVIORAL', 'otherNames': ['FPE', 'Family psychoeducation'], 'description': 'KUPAA is composed of 3 key components:\n\n1-2 Joining sessions \\[\\~30 to 45 minutes each\\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.\n\nEducational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.\n\n12 Family psychoeducation group sessions \\[\\~1.5 hours each session\\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.', 'armGroupLabels': ['KUPAA Intervention + Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Muhimbili University of Health and Allied Sciences (MUHAS)', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}, {'city': 'Mbeya', 'country': 'Tanzania', 'facility': 'Mbeya Zonal Referral Hospital', 'geoPoint': {'lat': -8.9, 'lon': 33.45}}], 'overallOfficials': [{'name': 'Joy Noel Baumgartner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'By November, 2020', 'ipdSharing': 'YES', 'description': 'Adhering to NIMH requirements on sharing data through NIMH Data Archive', 'accessCriteria': 'NIMH Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}