Protocol for a Feasibility Cluster Randomised Controlled Trial of a Home-based Depression Care for Older People Delivered by Lay Providers in Nigeria

Study Overview
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Brief Summary
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The aim of this hybrid (Effectiveness-Implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-Age) in routine home-based care of older Nigerians with depression. The main questions it aims to answer are: Whether the emhGAP-Age demonstrate sufficient signals of effectiveness in the identification and home management of late life depression to permit for further exploration in a fully powered clinical trial? What are the logistical, programmatic, and operational requirements for a home-delivered emhGAP-Age in a sample of older people with depression in Nigeria? Consenting older participants with depression in the intervention arm will receive treatment based on emhGAP-Age which consists of; Adapted electronic generic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-IG) Adapted Problem-Solving Therapy (PST-PC) Support/supervision of providers Links to social support resources. Researchers will compare with treatment based on the basic specification in the generic emhGAP-IG (consisting of basic psychoeducation and stress reduction) for effects on depression remission.

Official Title
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Intervention for Depression in Underserved Geriatric Populations

Conditions
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Depression in Old Age

Intervention / Treatment
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* Behavioral: emhGAP-Age


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years, PHQ-9 score of ≥11 during routine consultation Exclusion Criteria: Severe co-morbidity requiring urgent attention. Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) . Active suicidal intention. Evidence of bipolar/psychosis/severe substance use disorders. Planning to move out of the study catchment area within 6 months. Refusing/lacking capacity to consent/accent

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Age emhGAP-IG<br>Adapted emhGAP-IG; Adapted Problem-Solving Therapy (PST-PC) Support/supervision of lay providers Links to social support resources. | Behavioral: emhGAP-Age<br>* Adapted emhGAP-IG; Adapted Problem-Solving Therapy (PST-PC) Support/supervision of lay providers Links to social support resources.<br>|
| Active Comparator: Generic emhGAP-IG<br>Psychoeducation and stress reduction | Behavioral: emhGAP-Age<br>* Adapted emhGAP-IG; Adapted Problem-Solving Therapy (PST-PC) Support/supervision of lay providers Links to social support resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression remission | Patient Health Questionnaire (PHQ-9) score < 6 | At six months post trial entry |