Schizophrenia Clinical Trial
— TaSCSOfficial title:
Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Verified date | November 2017 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.
Status | Completed |
Enrollment | 324 |
Est. completion date | November 16, 2017 |
Est. primary completion date | May 16, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years and older |
Eligibility |
Inclusion criteria for phase 1 - Participant in the ongoing Butajira SMD cohort study (at baseline (between 1998 and 2001), cohort participants were aged between 15 and 49 years, resident in the area for at least six months and had a DSM-IV (SCAN) diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder) - Ongoing need for continuing mental health care due to: 1. being on psychotropic medication at assessment or, 2. not on medication but symptomatic at the time of assessment, or 3. have experienced partial or full relapse within the two years preceding the assessment - Stable clinical condition: either in remission from SMD or with residual symptoms that have been stable over the preceding three months. - Planning to stay resident in the area for 18 months. - Able to communicate in Amharic, the official language of Ethiopia. - Willing to be randomised to either of the service models as described in the protocol. - Has capacity to consent to participation or permission given by guardian and not refusing to participate - Resident in catchment area of TaSCS health centres (excluding Butajira health centre) Exclusion criteria for phase 1 - Suicide attempt within the preceding three months - Current active suicide intent - Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine), as these medications are not be available in psychiatric nurse-led units or PHC settings in Ethiopia. Within the Butajira SMD cohort, only people who have received care from psychiatrist-led units in the capital city, Addis Ababa, might be receiving these medications. At present, fewer than 10 patients are known to be taking one of these medications. - Prescribed depot medication - Complex or unstable medical condition interfering with management of psychiatric disorder or requiring ongoing medical treatment from Butajira hospital - Alcohol or khat dependence or abuse within the last 12 months - Pregnant or breast-feeding - Restrained at home - Refusing to participate in the study Inclusion criteria for Phase 2 As for Phase 1, but if we are unable to recruit enough participants from the existing Butajira SMD cohort then we will expand recruitment to people with SMD attending the psychiatric out-patient clinic at Butajira hospital. A semi-structured diagnostic interview will be carried out to determine diagnostic eligibility (DSM-IV diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder). For participants recruited from Butajira hospital psychiatric out-patient clinic, the minimum age will be 25 years and the participants should have had their first contact with specialist mental health services at least two years prior to recruitment into the trial to ensure comparability with the Butajira SMD cohort sample. Exclusion criteria for Phase 2 - Current active suicide intent - Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine). - Pregnant or breast-feeding and prescribed depot - Refusing to participate in the study - Medical condition requiring ongoing medical treatment from Butajira hospital |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Butajira mental health research office | Butajira |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | Addis Ababa University, Armauer Hansen Research Institute, Ethiopia, Columbia University, Johns Hopkins University, King's College London |
Ethiopia,
Alem A, Kebede D, Fekadu A, Shibre T, Fekadu D, Beyero T, Medhin G, Negash A, Kullgren G. Clinical course and outcome of schizophrenia in a predominantly treatment-naive cohort in rural Ethiopia. Schizophr Bull. 2009 May;35(3):646-54. doi: 10.1093/schbul/sbn029. Epub 2008 Apr 29. — View Citation
Federal Democratic Republic of Ethiopia Ministry of Health (2012). National Mental Health Strategy, 2012/13-2015/16. Addis Ababa, Ministry of Health.
mhGAP: Mental Health Gap Action Programme: Scaling Up Care for Mental, Neurological and Substance Use Disorders. Geneva: World Health Organization; 2008. — View Citation
Overall, J. and D. Gorham (1962). The Brief Psychiatric Rating Scale. Psychological Reports 10: 799-812.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) | Symptom severity scale. Non-inferiority of the experimental intervention is defined as less than six point difference in BPRS-E score between the two arms. | 12 months post-randomisation (18 months for secondary outcome) | |
Secondary | WHO Disability Assessment Scale, version 2.0 (WHODAS 2.0) | Generic disability scale. | 12 and 18 months post-randomisation | |
Secondary | Local functioning scale (disability scale for people with severe mental disorders developed specifically for this trial) | Contextually appropriate l. | 12 and 18 months post-randomisation | |
Secondary | Relapse of mental disorder (Measured using the Life Chart Schedule) | Measured using the Life Chart Schedule | 12 and 18 months post-randomisation | |
Secondary | Patient service satisfaction (Newly developed 'mental health service satisfaction scale' and qualitative interviews.) | Newly developed 'mental health service satisfaction scale' and qualitative interviews. | 12 and 18 months post-randomisation | |
Secondary | Nutritional status (Body mass index.) | Body mass index. | 12 and 18 months post-randomisation | |
Secondary | Service use for physical health care (Client Service Receipt Inventory) | Captured through reimbursement mechanisms and the Client Service Receipt Inventory | 12 and 18 months post-randomisation | |
Secondary | Medication side effects (Antipsychotic Side effect Checklist) | Measured using the Antipsychotic Side effect Checklist | 12 and 18 months post-randomisation | |
Secondary | Patient adherence and engagement (Medication Adherence Measure and tracking of appointment attendance.) | Medication Adherence Measure and tracking of appointment attendance. | 12 and 18 months post-randomisation | |
Secondary | Stigma (Family Interview Schedule (caregivers) | Internalised stigma of mental illness (patients) and the Family Interview Schedule (caregivers) | 12 and 18 months post-randomisation | |
Secondary | Restraint (Proportion chained, restrained of confined in the past month.) | Proportion chained, restrained of confined in the past month. | 12 and 18 months post-randomisation | |
Secondary | Adverse event | Life Chart Schedule and tracking of serious adverse events. | 12 and 18 months post-randomisation | |
Secondary | Quality of clinical care (WHO's mental health gap intervention guide) | Systematic evaluation of quality of documented care compared to evidence-based recommendations in WHO's mental health gap intervention guide. | 12 and 18 months post-randomisation | |
Secondary | Acceptability and feasibility (in-depth interviews with patients, caregivers and health care providers.) | Qualitative study using in-depth interviews with patients, caregivers and health care providers. | 6 months post-randomisation onwards |
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