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

Intervention for Depression in Underserved Geriatric Populations

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06125899
Acronym
INDIGO
Enrollment
110
Registered
2023-11-09
Start date
2024-02-29
Completion date
2025-07-31
Last updated
2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Old Age

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.

Interventions

BEHAVIORALemhGAP-Age

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

Sponsors

University of Ibadan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depression remissionAt six months post trial entryPatient Health Questionnaire (PHQ-9) score \< 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026