NCT06125899Not yet recruitingNot Applicable
Intervention for Depression in Underserved Geriatric Populations
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Ibadan
- Enrollment
- 110
- Primary Endpoint
- Depression remission
Study Overview
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:
- 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?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 60 years,
- •PHQ-9 score of ≥11 during routine consultation
Exclusion Criteria
- •Severe co-morbidity requiring urgent attention.
- •Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) .
- •Active suicidal intention.
- •Evidence of bipolar/psychosis/severe substance use disorders.
- •Planning to move out of the study catchment area within 6 months.
- •Refusing/lacking capacity to consent/accent
Arms & Interventions
Age emhGAP-IG
Experimental
- Adapted emhGAP-IG;
- Adapted Problem-Solving Therapy (PST-PC)
- Support/supervision of lay providers
- Links to social support resources.
Intervention: emhGAP-Age (Behavioral)
Generic emhGAP-IG
Active Comparator
Psychoeducation and stress reduction
Intervention: emhGAP-Age (Behavioral)
Outcomes
Primary Outcomes
Depression remission
Time Frame: At six months post trial entry
Patient Health Questionnaire (PHQ-9) score \< 6
Secondary Outcomes
No secondary outcomes reported
Investigators
Akin Ojagbemi
Senior Lecturer
University of Ibadan
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