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

Not Applicable

Not yet recruiting

• Conditions: Depression in Old Age
• Interventions: Behavioral: emhGAP-Age

• Registration Number: NCT06125899
• Lead Sponsor: University of Ibadan

Brief Summary

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:

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09
• Study Start: 2024-02
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Age ≥ 60 years,
2. PHQ-9 score of ≥11 during routine consultation

Exclusion Criteria

1. Severe co-morbidity requiring urgent attention.
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Age emhGAP-IG	emhGAP-Age	* Adapted emhGAP-IG; * Adapted Problem-Solving Therapy (PST-PC) * Support/supervision of lay providers * Links to social support resources.
Generic emhGAP-IG	emhGAP-Age	Psychoeducation and stress reduction

Primary Outcome Measures

Name	Time	Method
Depression remission	At six months post trial entry	Patient Health Questionnaire (PHQ-9) score \< 6