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

NCT02308956 | Completed Phase 3 DMC

• 1 other identifier: NIH-95699 (Ethiopia)
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder; Major Depressive Disorder; Schizoaffective Disorder

Keywords

task sharing; task shifting; community mental health care; primary care; Developing country; Sub-Saharan Africa; non-inferiority trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• WHO Disability Assessment Scale, version 2.0 (WHODAS 2.0)

  12 and 18 months post-randomisation

• Local functioning scale (disability scale for people with severe mental disorders developed specifically for this trial)

  12 and 18 months post-randomisation

• Relapse of mental disorder (Measured using the Life Chart Schedule)

  12 and 18 months post-randomisation

• Patient service satisfaction (Newly developed 'mental health service satisfaction scale' and qualitative interviews.)

  12 and 18 months post-randomisation

• Nutritional status (Body mass index.)

  12 and 18 months post-randomisation

Study Arms (2)

Integrated mental health in primary care

EXPERIMENTAL

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

Psychiatric nurse-led specialist care

ACTIVE COMPARATOR

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

Interventions

Integrated mental health in primary care BEHAVIORAL

A task-shared model of collaborative mental health care integrated into the primary care setting.

Integrated mental health in primary care

Psychiatric nurse-led specialist care BEHAVIORAL

A centralised, psychiatric nurse-led, hospital out-patient service with outreach from project outreach workers

Psychiatric nurse-led specialist care

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• being on psychotropic medication at assessment or,
• not on medication but symptomatic at the time of assessment, or
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Cape Town: lead
• Addis Ababa University: collaborator
• King's College London: collaborator
• Johns Hopkins University: collaborator
• Columbia University: collaborator
• Armauer Hansen Research Institute, Ethiopia: collaborator

Study Sites (1)

Butajira mental health research office

Butajīra, Ethiopia

Location

Related Publications (6)

• 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.

  PMID: 18448478 BACKGROUND

• Federal Democratic Republic of Ethiopia Ministry of Health (2012). National Mental Health Strategy, 2012/13-2015/16. Addis Ababa, Ministry of Health.

  BACKGROUND

• mhGAP: Mental Health Gap Action Programme: Scaling Up Care for Mental, Neurological and Substance Use Disorders. Geneva: World Health Organization; 2008. Available from http://www.ncbi.nlm.nih.gov/books/NBK310851/

  PMID: 26290926 BACKGROUND

• Overall, J. and D. Gorham (1962). The Brief Psychiatric Rating Scale. Psychological Reports 10: 799-812.

  BACKGROUND

• Hanlon C, Medhin G, Dewey ME, Prince M, Assefa E, Shibre T, Ejigu DA, Negussie H, Timothewos S, Schneider M, Thornicroft G, Wissow L, Susser E, Lund C, Fekadu A, Alem A. Efficacy and cost-effectiveness of task-shared care for people with severe mental disorders in Ethiopia (TaSCS): a single-blind, randomised, controlled, phase 3 non-inferiority trial. Lancet Psychiatry. 2022 Jan;9(1):59-71. doi: 10.1016/S2215-0366(21)00384-9.

  PMID: 34921796 DERIVED

• Hanlon C, Alem A, Medhin G, Shibre T, Ejigu DA, Negussie H, Dewey M, Wissow L, Prince M, Susser E, Lund C, Fekadu A. Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial. Trials. 2016 Feb 11;17:76. doi: 10.1186/s13063-016-1191-x.

  PMID: 26865254 DERIVED

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Psychotic Disorders

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Charlotte Hanlon, BM BS, PhD

  Addis Ababa University and King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: March 1, 2015
• Primary Completion: May 16, 2017
• Study Completion: November 16, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

ET (1)