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

University of Ibadan

Status: Not yet enrolling

Conditions: Depression in Old Age

Treatments: Behavioral: emhGAP-Age

Study type: Interventional

Funder types: Other

Identifiers

NCT06125899

220684/Z/20/Z

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 2 patient groups

Age emhGAP-IG

Experimental group

Description:

* Adapted emhGAP-IG; * Adapted Problem-Solving Therapy (PST-PC) * Support/supervision of lay providers * Links to social support resources.

Treatment:

Behavioral: emhGAP-Age

Generic emhGAP-IG

Active Comparator group

Description:

Psychoeducation and stress reduction

Treatment:

Behavioral: emhGAP-Age