Protocol for a Feasibility Cluster Randomised Controlled Trial of a Home-based Depression Care for Older People Delivered by Lay Providers in Nigeria
NCT ID: NCT06125899
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2024-02-29
2025-07-31
Brief Summary
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1. 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?
2. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Age emhGAP-IG
* Adapted emhGAP-IG;
* Adapted Problem-Solving Therapy (PST-PC)
* Support/supervision of lay providers
* Links to social support resources.
emhGAP-Age
* Adapted emhGAP-IG;
* Adapted Problem-Solving Therapy (PST-PC)
* Support/supervision of lay providers
* Links to social support resources.
Generic emhGAP-IG
Psychoeducation and stress reduction
emhGAP-Age
* Adapted emhGAP-IG;
* Adapted Problem-Solving Therapy (PST-PC)
* Support/supervision of lay providers
* Links to social support resources.
Interventions
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emhGAP-Age
* Adapted emhGAP-IG;
* Adapted Problem-Solving Therapy (PST-PC)
* Support/supervision of lay providers
* Links to social support resources.
Eligibility Criteria
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Inclusion Criteria
2. PHQ-9 score of ≥11 during routine consultation
Exclusion Criteria
2. Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) .
3. Active suicidal intention.
4. Evidence of bipolar/psychosis/severe substance use disorders.
5. Planning to move out of the study catchment area within 6 months.
6. Refusing/lacking capacity to consent/accent
60 Years
ALL
No
Sponsors
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University of Ibadan
OTHER
Responsible Party
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Akin Ojagbemi
Senior Lecturer
Other Identifiers
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220684/Z/20/Z
Identifier Type: -
Identifier Source: org_study_id
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