NCT04522453

Brief Summary

Two strategies will be compared for training and supervising primary care workers delivering mental health services. Both strategies will use the World Health Organization mental health Gap Action Program-Intervention Guide. In the standard strategy, the paper-based version of the mental health Gap Action Program-Intervention Guide will be used. In the novel strategy an electronic version of the mental health Gap Action Program-Intervention Guide that can be used on mobile digital devices will be given to primary care workers. This is a feasibility cluster-randomized controlled trial to establish parameters for conducting a fully-powered cluster-randomized controlled trial comparing the paper versus digital strategy. The primary outcome of the subsequent fully powered trial will be the difference in accurate detection of depression.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
3,351

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Dec 2020

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 27, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

July 29, 2020

Last Update Submit

September 27, 2022

Conditions

Depression

Keywords

Primary careCompetenceMobile healthMental healthLow- and middle-income countriesTrainingSupervision

Outcome Measures

Primary Outcomes (1)

  • Mental Health Gap Action Programme Depression Diagnosis Tool

    Unnabbreviated name of scale: "Mental Health Gap Action Programme Depression Diagnosis Tool"; Primary care health workers diagnosis of depression documented in clinical records; Unit of measure: % of patients with Mental Health Gap Action Programme Depression Diagnosis compared to number of patients with positive Patient Health Questionnaire depression screen

    Three months post training

Secondary Outcomes (37)

  • Mental Health Gap Action Programme Depression Diagnosis Tool

    One month prior to training

  • Patient health questionnaire 9

    One month prior to training

  • Patient health questionnaire 9

    Three months post training

  • Patient health questionnaire 9

    Six months post training

  • World Health Organization Disability Assessment Schedule

    One month pre training

  • +32 more secondary outcomes

Study Arms (2)

paper mental health Gap Action Program-Intervention Guide

ACTIVE COMPARATOR

This arm will be training and supervision as usual employing the standard paper version of the mental health Gap Action Program-Intervention Guide. Primary care workers will be trained to use the paper version of this tool and will use the paper version when evaluating patients.

Other: paper-based version of mental health Gap Action Program-Intervention Guide

digital mental health Gap Action Program-Intervention Guide

EXPERIMENTAL

This arm will be training and supervision in an experimental approach using a digital version of version of the mental health Gap Action Program-Intervention Guide. The digital version allows for interactive decision making on diagnoses and care, and it allows for entering of patient data. Primary care workers in this arm will be trained to use the digital version of this tool and will use the digital version when evaluating patients.

Other: digital version of the mental health Gap Action Program-Intervention Guide

Interventions

paper-based version of mental health Gap Action Program-Intervention GuideOTHER

A paper-based guide for diagnosis and management of mental disorders in primary care.

paper mental health Gap Action Program-Intervention Guide
digital version of the mental health Gap Action Program-Intervention GuideOTHER

A digital guide and client data entry tool for diagnosis and management of mental disorders in primary care.

digital mental health Gap Action Program-Intervention Guide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary Care Health Workers: Primary healthcare staff will be eligible to participate if they are employed by the primary care clinic or government and have roles and responsibilities that relate to the use of the mental health Gap Action Program (e.g. direct clinical use or supervision). All relevant primary care staff, regardless of individual study participation, will receive training in the mental health Gap Action Program. (electronic or paper version) and have ongoing remote support and supervision.
  • Patients: Attending primary care for treatment; fluent in Nepali (for Nepal site) or Yoruba (for Nigeria site);

You may not qualify if:

  • Patients: Adult attendees will be deemed ineligible for the study if they are unable to understand or complete study assessment (e.g. individuals with severe learning disability or dementia), unable give informed consent, or have a medical emergency requiring immediate intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Transcultural Psychosocial Organization Nepal

Kathmandu, Nepal

Location

University of Ibadan

Ibadan, Oyo State, Nigeria

Location

Related Publications (2)

  • Kohrt BA, Ojagbemi A, Luitel NP, Bakolis I, Bello T, McCrone P, Taylor Salisbury T, Jordans MJD, Votruba N, Carswell K, Green E, Gkaintatzi E, Lamichhane B, Elugbadebo O, Kola L, Lempp H, Chowdhary N, Dua T, Gureje O, Thornicroft G. An App-Based WHO Mental Health Guide for Depression Detection: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2512064. doi: 10.1001/jamanetworkopen.2025.12064.

    PMID: 40408108DERIVED

  • Taylor Salisbury T, Kohrt BA, Bakolis I, Jordans MJ, Hull L, Luitel NP, McCrone P, Sevdalis N, Pokhrel P, Carswell K, Ojagbemi A, Green EP, Chowdhary N, Kola L, Lempp H, Dua T, Milenova M, Gureje O, Thornicroft G. Adaptation of the World Health Organization Electronic Mental Health Gap Action Programme Intervention Guide App for Mobile Devices in Nepal and Nigeria: Protocol for a Feasibility Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Jun 15;10(6):e24115. doi: 10.2196/24115.

    PMID: 34128819DERIVED

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Graham Thornicroft, MD, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors will not be informed whether primary care providers or patients are in the paper of digital arm of the mental health Gap Action Program.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Feasibility cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 21, 2020

Study Start

December 27, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

An individual participant data sharing plan will address both primary care health worker and patient data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
An individual participant data sharing plan and approach will developed for sharing after dissemination of the primary findings.
Access Criteria
Contact study investigators with data request.

Locations

NE(1)NG(1)