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

Depression in Old Age Clinical Trial

— INDIGO  

Official title:

Intervention for Depression in Underserved Geriatric Populations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06125899
• Other study ID #: 220684/Z/20/Z
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression in Old Age
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ibadan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression remission	Patient Health Questionnaire (PHQ-9) score < 6	At six months post trial entry