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

November 8, 2023 updated by: Akin Ojagbemi, University of Ibadan

Intervention for Depression in Underserved Geriatric Populations

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Age emhGAP-IG
  • Adapted emhGAP-IG;
  • Adapted Problem-Solving Therapy (PST-PC)
  • Support/supervision of lay providers
  • Links to social support resources.
Behavioral: emhGAP-Age
  • Adapted emhGAP-IG;
  • Adapted Problem-Solving Therapy (PST-PC)
  • Support/supervision of lay providers
  • Links to social support resources.
Active Comparator: Generic emhGAP-IG
Psychoeducation and stress reduction
Behavioral: emhGAP-Age
  • Adapted emhGAP-IG;
  • Adapted Problem-Solving Therapy (PST-PC)
  • Support/supervision of lay providers
  • Links to social support resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression remission
Time Frame: At six months post trial entry
Patient Health Questionnaire (PHQ-9) score < 6
At six months post trial entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ibadan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220684/Z/20/Z

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression in Old Age

Clinical Trials on emhGAP-Age

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe