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

Last updated: November 8, 2023
Sponsor: University of Ibadan
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Treatment

emhGAP-Age

Clinical Study ID

NCT06125899
220684/Z/20/Z
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Severe co-morbidity requiring urgent attention.
  2. Severe cognitive impairment/dementia (Community Screening Instruments for Dementiascore≤ 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

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: emhGAP-Age
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
July 31, 2025