NCT06125899

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:

  • 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

November 5, 2023

Last Update Submit

November 8, 2023

Conditions

Depression in Old Age

Outcome Measures

Primary Outcomes (1)

  • Depression remission

    Patient Health Questionnaire (PHQ-9) score \< 6

    At six months post trial entry

Study Arms (2)

Age emhGAP-IG

EXPERIMENTAL

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

Behavioral: emhGAP-Age

Generic emhGAP-IG

ACTIVE COMPARATOR

Psychoeducation and stress reduction

Behavioral: emhGAP-Age

Interventions

emhGAP-AgeBEHAVIORAL

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

Age emhGAP-IGGeneric emhGAP-IG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years,
  • PHQ-9 score of ≥11 during routine consultation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

November 5, 2023

First Posted

November 9, 2023

Study Start

February 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

November 9, 2023

Record last verified: 2023-11