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Task Sharing for the Care of Severe Mental Disorders in a Low-income Country (TaSCS)

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ClinicalTrials.gov Identifier: NCT02308956
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : November 29, 2017
Sponsor:
Collaborators:
Addis Ababa University
King's College London
Johns Hopkins University
Columbia University
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Charlotte Hanlon, Addis Ababa University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Major Depressive Disorder Schizoaffective Disorder Behavioral: Integrated mental health in primary care Behavioral: Psychiatric nurse-led specialist care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Study Start Date : March 2015
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : November 16, 2017


Arm Intervention/treatment
Experimental: Integrated mental health in primary care
Participants in the new intervention arm will receive a task sharing model of locally-delivered mental health care integrated into primary healthcare. General health workers (health officers, nurses and community-based health extension workers) will be given brief training using the WHO's mental health Gap Action Programme and ongoing supervision in order to deliver mental health care to people with severe mental disorders.
Behavioral: Integrated mental health in primary care
A task-shared model of collaborative mental health care integrated into the primary care setting.

Active Comparator: Psychiatric nurse-led specialist care
Participants in the active control arm will receive an established model of centralised, specialist mental health care delivered by psychiatric nurses at an out-patient clinic within Butajira general hospital and supported by outreach from project workers.
Behavioral: Psychiatric nurse-led specialist care
A centralised, psychiatric nurse-led, hospital out-patient service with outreach from project outreach workers




Primary Outcome Measures :
  1. Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) [ Time Frame: 12 months post-randomisation (18 months for secondary outcome) ]
    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.


Secondary Outcome Measures :
  1. WHO Disability Assessment Scale, version 2.0 (WHODAS 2.0) [ Time Frame: 12 and 18 months post-randomisation ]
    Generic disability scale.

  2. Local functioning scale (disability scale for people with severe mental disorders developed specifically for this trial) [ Time Frame: 12 and 18 months post-randomisation ]
    Contextually appropriate l.

  3. Relapse of mental disorder (Measured using the Life Chart Schedule) [ Time Frame: 12 and 18 months post-randomisation ]
    Measured using the Life Chart Schedule

  4. Patient service satisfaction (Newly developed 'mental health service satisfaction scale' and qualitative interviews.) [ Time Frame: 12 and 18 months post-randomisation ]
    Newly developed 'mental health service satisfaction scale' and qualitative interviews.

  5. Nutritional status (Body mass index.) [ Time Frame: 12 and 18 months post-randomisation ]
    Body mass index.

  6. Service use for physical health care (Client Service Receipt Inventory) [ Time Frame: 12 and 18 months post-randomisation ]
    Captured through reimbursement mechanisms and the Client Service Receipt Inventory

  7. Medication side effects (Antipsychotic Side effect Checklist) [ Time Frame: 12 and 18 months post-randomisation ]
    Measured using the Antipsychotic Side effect Checklist

  8. Patient adherence and engagement (Medication Adherence Measure and tracking of appointment attendance.) [ Time Frame: 12 and 18 months post-randomisation ]
    Medication Adherence Measure and tracking of appointment attendance.

  9. Stigma (Family Interview Schedule (caregivers) [ Time Frame: 12 and 18 months post-randomisation ]
    Internalised stigma of mental illness (patients) and the Family Interview Schedule (caregivers)

  10. Restraint (Proportion chained, restrained of confined in the past month.) [ Time Frame: 12 and 18 months post-randomisation ]
    Proportion chained, restrained of confined in the past month.

  11. Adverse event [ Time Frame: 12 and 18 months post-randomisation ]
    Life Chart Schedule and tracking of serious adverse events.

  12. Quality of clinical care (WHO's mental health gap intervention guide) [ Time Frame: 12 and 18 months post-randomisation ]
    Systematic evaluation of quality of documented care compared to evidence-based recommendations in WHO's mental health gap intervention guide.

  13. Acceptability and feasibility (in-depth interviews with patients, caregivers and health care providers.) [ Time Frame: 6 months post-randomisation onwards ]
    Qualitative study using in-depth interviews with patients, caregivers and health care providers.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308956


Locations
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Ethiopia
Butajira mental health research office
Butajira, Ethiopia
Sponsors and Collaborators
University of Cape Town
Addis Ababa University
King's College London
Johns Hopkins University
Columbia University
Armauer Hansen Research Institute, Ethiopia
Investigators
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Principal Investigator: Charlotte Hanlon, BM BS, PhD Addis Ababa University and King's College London
Publications:
Federal Democratic Republic of Ethiopia Ministry of Health (2012). National Mental Health Strategy, 2012/13-2015/16. Addis Ababa, Ministry of Health.
World Health Organization (2008). mhGAP Mental Health Gap Action Programme: scaling up care for mental, neurological and substance use disorders. . Geneva, WHO.
Overall, J. and D. Gorham (1962). The Brief Psychiatric Rating Scale. Psychological Reports 10: 799-812.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Charlotte Hanlon, Principal Investigator, Addis Ababa University
ClinicalTrials.gov Identifier: NCT02308956    
Other Study ID Numbers: NIH-95699 (Ethiopia)
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Keywords provided by Charlotte Hanlon, Addis Ababa University:
task sharing
task shifting
community mental health care
primary care
Developing country
Sub-Saharan Africa
non-inferiority trial
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Bipolar and Related Disorders