DepressionEMILIANCT04522453
E-MhGAP Intervention Guide in Low- and Middle-income Countries: Proof-of-concept for Impact and Acceptability
A study testing paper-based version of mental health Gap Action Program-Intervention Guide and digital version of the mental health Gap Action Program-Intervention Guide in people with Depression, run by George Washington University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- paper-based version of mental health Gap Action Program-Intervention Guide and digital version of the mental health Gap Action Program-Intervention Guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,351 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Dec 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- Primary Care Health Workers: No exclusion criteria.
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the detailed description
Mental illnesses are common, affecting one in every three people during their lifetimes. Globally, mental illnesses are the leading contributor of years lived with a disability. Despite the prevalence and impact of mental illness, a large difference between true and treated prevalence rates of mental disorders, also known as the mental health treatment gap, exists. It is estimated that more than 80% of people with severe mental illness in low and middle-income countries receive no treatment. Only 16.5% of people with depression living in low- and middle-income countries have access to minimally adequate treatment. The consequences of this treatment gap include symptom persistence and deterioration, social exclusion, and long-term disability of people who could be economically productive and socially included. Globally, there is growing recognition of the importance of mental health as evidenced by its inclusion in the 2030 United Nations Agenda for Sustainable Development and extension of the World Health Organization Comprehensive Mental Health Action Plan to 2030 by the World Health Assembly.
Limited numbers of mental health specialists and the concentration of care in hospital settings limits the availability and accessibility of care. Low treatment rates in low- and middle-income countries are related to poor demand and supply-side forces. High levels of stigma associated with mental illness manifest in low rates of help-seeking among those who would benefit from care. The World Health Organization recommends a task-shifting approach to strengthen the generalist workforce and improve access to health care, including mental health care. However, this requires the availability of evidence-based tools and appropriate training, supervision, and support.
In recent years there has been an exponential rise in global access to mobile technologies in low- and middle-income countries. In 2012 there were 287 million unique mobile phone subscribers across sub-Saharan Africa covering 32% of the population. Six years later, that number rose to 465 million representing 44% of the population. In Nepal, the number of mobile contracts surpasses the total population (26.49 million). The increased application of mobile technology to healthcare arena, known as mobile health (mobile-health), aims to provide a powerful platform to improve the quality of interventions employing a task-shifting approach and reduce the treatment gap. Mobile health (mobile-health) refers to the use of mobile technology in health interventions and service provision. In a recent World Health Organization survey, 87% of responding countries reported at least one government sponsored mobile-health programme in their country. However, only 14% of countries reported an evaluation of these programmes, raising concerns about insufficient evidence of impact.
A systematic review of smartphone use in clinical decision making by healthcare professionals identified seven randomised control trials conducted in high-income settings, which demonstrated improved knowledge, diagnosis, treatment decisions and documentation using mobile-health technology. Studies on mobile-health tools in low- and middle-income countries have had more mixed results. Improved compliance to protocols has been demonstrated with a smart phone tool in India. Conversely, a study in Uganda failed to show improvement in service user outcomes when community-based peer workers used mobile phones to communicate with supervisors. Qualitative data does, however, suggest the intervention facilitated task shifting and improved health worker morale.
In 2010, the World Health Organization launched the Mental Health Gap Action Programme Intervention Guide, an evidence-based assessment and management guide for mental, neurological and substance use conditions designed for use by primary and community health staff in low- and middle-income countries. The first edition of the mental health Gap Action Program-Intervention Guide has been implemented in over 100 countries. An updated version was launched in 2016 with new sections and updated evidence-based guidance. The mental health Gap Action Program-Intervention Guide v2.0 consists of eight modules addressing priority conditions (i.e. depression, psychoses, epilepsy, child and adolescent mental and behavioural disorders, dementia, disorders due to substance use, self-harm/suicide and conditions related to extreme stress). The guide provides an overview of common presentations for each condition followed by detailed guidance for assessment, management (including referral to specialist care) and follow-up.
The E-mental health Gap Action Program Intervention guide in Low and middle-income countries: proof-of-concept for Impact and Acceptability (Emilia) project seeks to re-address the treatment gap by developing a potentially practicable way for primary health care staff to monitor and treat people with mental illness according to evidence-based guidelines. The project is comprised of three phases: (1) development of an adapted e-mental health Gap Action Program intervention guide, (2) feasibility testing, and (3) knowledge transfer and future work.
Objectives
Emilia aims to test the feasibility of an electronic version of the mental health Gap Action Program-Intervention Guide v2.0 and trial procedures for the future evaluation of a large-scale trial, which would evaluate differences in depression detection between facilities using e-mental health Gap Action Program vs. paper mental health Gap Action Program. The objectives of this feasibility study, in preparation for a future trial, include the following:
- To evaluate the feasibility and acceptability of primary care mental health services utilizing the e-mental health Gap Action Program-Intervention Guide for training, supervision, and delivery of care [primary objective];
- To determine recruitment and retention rates for primary care workers and patients;
- To establish the acceptability and feasibility of assessing primary health worker and patient outcomes;
- To assess ethics and safety procedures using adverse event reporting;
- To describe depression detection rates in primary health clinics; and
- To describe depression treatment outcomes in primary health clinics.
- Conditions
- Depression
- Being tested
- paper-based version of mental health Gap Action Program-Intervention Guide, digital version of the mental health Gap Action Program-Intervention Guide
- Keywords
- Primary care, Competence, Mobile health, Mental health, Low- and middle-income countries, Training, Supervision
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: digital version of the mental health Gap Action Program-Intervention Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months post training
Secondary outcomes (37)
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
Measured: One month prior to training
Patient health questionnaire 9
Unabbreviated scale title "Patient health questionnaire 9"; Self reported symptoms of depression; minimum 0, maximum 27; high score is worse outcome
Measured: One month prior to training
Patient health questionnaire 9
Unabbreviated scale title "Patient health questionnaire 9"; Self reported symptoms of depression; minimum 0, maximum 27; high score is worse outcome
Measured: Three months post training
Patient health questionnaire 9
Unabbreviated scale title "Patient health questionnaire 9"; Self reported symptoms of depression; minimum 0, maximum 27; high score is worse outcome
Measured: Six months post training
World Health Organization Disability Assessment Schedule
Unabbreviated name of scale: "World Health Organization Disability Assessment Schedule"; Self reported measure of functional impairment; Minimum score 0, Maximum 60; higher score is worse outcome
Measured: One month pre training
World Health Organization Disability Assessment Schedule
Unabbreviated name of scale: "World Health Organization Disability Assessment Schedule"; Self reported measure of functional impairment; Minimum score 0, Maximum 60; higher score is worse outcome
Measured: Three months post training
World Health Organization Disability Assessment Schedule
Unabbreviated name of scale: "World Health Organization Disability Assessment Schedule"; Self reported measure of functional impairment; Minimum score 0, Maximum 60; higher score is worse outcome
Measured: Six months post training
Mental health gap action program knowledge assessment
Unabbreviated scale title: "Mental health gap action program knowledge assessment"; Multiple choice test of mental disorder diagnosis and management; Minimum score 0%, Maximum 100%, higher score is better outcome
Measured: One day pre training
Mental health gap action program knowledge assessment
Unabbreviated scale title: "Mental health gap action program knowledge assessment"; Multiple choice test of mental disorder diagnosis and management; Minimum score 0%, Maximum 100%, higher score is better outcome
Measured: One day post training
Mental health gap action program knowledge assessment
Unabbreviated scale title: "Mental health gap action program knowledge assessment"; Multiple choice test of mental disorder diagnosis and management; Minimum score 0%, Maximum 100%, higher score is better outcome
Measured: Three months post training
Mental health gap action program knowledge assessment
Unabbreviated scale title: "Mental health gap action program knowledge assessment"; Multiple choice test of mental disorder diagnosis and management; Minimum score 0%, Maximum 100%, higher score is better outcome
Measured: Eight months post training
Enhancing Assessment of Common Therapeutic Factors
Unabbreviated title: "Enhancing Assessment of Common Therapeutic Factors"; Objective structured clinical examination of common factors and diagnostic practices; Minimum=15, Maximum=60; higher score is better outcome
Measured: One day pre training
Enhancing Assessment of Common Therapeutic Factors
Unabbreviated title: "Enhancing Assessment of Common Therapeutic Factors"; Objective structured clinical examination of common factors and diagnostic practices; Minimum=15, Maximum=60; higher score is better outcome
Measured: One day post training
Enhancing Assessment of Common Therapeutic Factors
Unabbreviated title: "Enhancing Assessment of Common Therapeutic Factors"; Objective structured clinical examination of common factors and diagnostic practices; Minimum=15, Maximum=60; higher score is better outcome
Measured: Three months post training
Enhancing Assessment of Common Therapeutic Factors
Unabbreviated title: "Enhancing Assessment of Common Therapeutic Factors"; Objective structured clinical examination of common factors and diagnostic practices; Minimum=15, Maximum=60; higher score is better outcome
Measured: Eight months post training
Social Distance Scale
Unabbreviated scale title: "Social Distance Scale"; Self reported measure of stigma against persons with mental illness; Minimum score=12, Maximum Score=72; higher score is worse outcome
Measured: One day pre training
Social Distance Scale
Unabbreviated scale title: "Social Distance Scale"; Self reported measure of stigma against persons with mental illness; Minimum score=12, Maximum Score=72; higher score is worse outcome
Measured: One day post training
Social Distance Scale
Unabbreviated scale title: "Social Distance Scale"; Self reported measure of stigma against persons with mental illness; Minimum score=12, Maximum Score=72; higher score is worse outcome
Measured: Three months post training
Social Distance Scale
Unabbreviated scale title: "Social Distance Scale"; Self reported measure of stigma against persons with mental illness; Minimum score=12, Maximum Score=72; higher score is worse outcome
Measured: Eight months post training
Enhancing Assessment of Common Therapeutic Factors - patient version
Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors - patient version"; Patient report of primary care workers common factors skills; minimum score=0, maximum score=15; higher score is better outcome
Measured: One month pre training
Enhancing Assessment of Common Therapeutic Factors - patient version
Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors - patient version"; Patient report of primary care workers common factors skills; minimum score=0, maximum score=15; higher score is better outcome
Measured: Three months post training
Enhancing Assessment of Common Therapeutic Factors - patient version
Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors - patient version"; Patient report of primary care workers common factors skills; minimum score=0, maximum score=15; higher score is better outcome
Measured: Six months post training
Acceptability of Intervention Measure
Unabbreviated scale title "Acceptability of Intervention Measure"; Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
Measured: Three months post training
Acceptability of Intervention Measure
Unabbreviated scale title "Acceptability of Intervention Measure"; Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
Measured: Eight months post training
Acceptability of Intervention Measure - patient version
Unabbreviated scale title "Acceptability of Intervention Measure"; Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
Measured: Six months post training
Feasibility of Intervention Measure
Unabbreviated title: " Feasibility of Intervention Measure"; Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better
Measured: Three months post training
Feasibility of Intervention Measure
Unabbreviated title: " Feasibility of Intervention Measure"; Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better
Measured: Eight months post training
Intervention Appropriateness Measure
Unabbreviated title: " Intervention Appropriateness Measure"; Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
Measured: Three months post training
Intervention Appropriateness Measure
Unabbreviated title: " Intervention Appropriateness Measure"; Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
Measured: Eight months post training
Intervention Appropriateness Measure - patient version
Unabbreviated title: " Intervention Appropriateness Measure"; Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
Measured: Six months post training
Organizational Readiness for Implementing Change
Unabbreviated title: "Organizational Readiness for Implementing Change"; Subjective report of readiness for implementing a new intervention; a 16-item tool to assess Assesses perspectives on intra- and extra-organizational implementation readiness; minimum=16, maximum=90; higher score is better
Measured: One day pre training
Normalization Measure Development
Unabbreviated title: "Normalization Measure Development"; Subjective report of normalization of measure development; a brief self-report questionnaire that could be helpful in measuring implementation progress. Based on the Normalization Process Theory, this instrument focuses on 4 generative mechanisms involved in implementation processes: coherence, cognitive participation, collective action, and reflexive monitoring. 20 items; minimum=20, maximum=100, higher score is better outcome
Measured: Eight months post-training
Perceptions of supervisory support scale
Unabbreviated title: "Perceptions of supervisory support scale"; Health workers perception of supervision support; 19 items, minimum score=19, maximum score=95; higher score is better outcome
Measured: Eight months post-training
Depression Attitudes Questionnaire
Unabbreviated title:"Depression Attitudes Questionnaire"; Health workers report of attitudes toward depression care; Minimum=10; Maximum=40, higher scores=better outcome
Measured: One day pre training
Depression Attitudes Questionnaire
Unabbreviated title:"Depression Attitudes Questionnaire"; Health workers report of attitudes toward depression care; Minimum=10; Maximum=40, higher scores=better outcome
Measured: One day post training
Depression Attitudes Questionnaire
Unabbreviated title:"Depression Attitudes Questionnaire"; Health workers report of attitudes toward depression care; Minimum=10; Maximum=40, higher scores=better outcome
Measured: One month post training
Depression Attitudes Questionnaire
Unabbreviated title:"Depression Attitudes Questionnaire"; Health workers report of attitudes toward depression care; Minimum=10; Maximum=40, higher scores=better outcome
Measured: Three months post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start27 Dec 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Duke University, Transcultural Psychosocial Organization Nepal, University of Ibadan, World Health Organization, Medical Research Council
- Responsible party
- Principal investigator, Brandon A Kohrt, MD, PhD, George Washington University
- Investigators
- Graham Thornicroft, MD, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522453
- Sponsor's protocol ID
- MR/R023697/1
- Acronym
- EMILIA
- Status last verified
- Sep 2022
- First submitted
- 29 Jul 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An individual participant data sharing plan will address both primary care health worker and patient data.
Publications
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.
PubMed 40408108Taylor 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.
PubMed 34128819
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-MhGAP Intervention Guide in Low- and Middle-income Countries: Proof-of-concept for Impact and Acceptability
- ClinicalTrials.gov ID
- NCT04522453
- Acronym / sponsor ID
- EMILIA / MR/R023697/1
- Conditions
- Depression
- Keywords
- Primary care, Competence, Mobile health, Mental health, Low- and middle-income countries, Training, Supervision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,351 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- King's College London, Duke University, Transcultural Psychosocial Organization Nepal, University of Ibadan, World Health Organization, Medical Research Council
- Study start
- 27 Dec 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mental illnesses are common, affecting one in every three people during their lifetimes. Globally, mental illnesses are the leading contributor of years lived with a disability. Despite the prevalence and impact of mental illness, a large difference between true and treated prevalence rates of mental disorders, also known as the mental health treatment gap, exists. It is estimated that more than 80% of people with severe mental illness in low and middle-income countries receive no treatment. Only 16.5% of people with depression living in low- and middle-income countries have access to minimally adequate treatment. The consequences of this treatment gap include symptom persistence and deterioration, social exclusion, and long-term disability of people who could be economically productive and socially included. Globally, there is growing recognition of the importance of mental health as evidenced by its inclusion in the 2030 United Nations Agenda for Sustainable Development and extension of the World Health Organization Comprehensive Mental Health Action Plan to 2030 by the World Health Assembly.
Limited numbers of mental health specialists and the concentration of care in hospital settings limits the availability and accessibility of care. Low treatment rates in low- and middle-income countries are related to poor demand and supply-side forces. High levels of stigma associated with mental illness manifest in low rates of help-seeking among those who would benefit from care. The World Health Organization recommends a task-shifting approach to strengthen the generalist workforce and improve access to health care, including mental health care. However, this requires the availability of evidence-based tools and appropriate training, supervision, and support.
In recent years there has been an exponential rise in global access to mobile technologies in low- and middle-income countries. In 2012 there were 287 million unique mobile phone subscribers across sub-Saharan Africa covering 32% of the population. Six years later, that number rose to 465 million representing 44% of the population. In Nepal, the number of mobile contracts surpasses the total population (26.49 million). The increased application of mobile technology to healthcare arena, known as mobile health (mobile-health), aims to provide a powerful platform to improve the quality of interventions employing a task-shifting approach and reduce the treatment gap. Mobile health (mobile-health) refers to the use of mobile technology in health interventions and service provision. In a recent World Health Organization survey, 87% of responding countries reported at least one government sponsored mobile-health programme in their country. However, only 14% of countries reported an evaluation of these programmes, raising concerns about insufficient evidence of impact.
A systematic review of smartphone use in clinical decision making by healthcare professionals identified seven randomised control trials conducted in high-income settings, which demonstrated improved knowledge, diagnosis, treatment decisions and documentation using mobile-health technology. Studies on mobile-health tools in low- and middle-income countries have had more mixed results. Improved compliance to protocols has been demonstrated with a smart phone tool in India. Conversely, a study in Uganda failed to show improvement in service user outcomes when community-based peer workers used mobile phones to communicate with supervisors. Qualitative data does, however, suggest the intervention facilitated task shifting and improved health worker morale.
In 2010, the World Health Organization launched the Mental Health Gap Action Programme Intervention Guide, an evidence-based assessment and management guide for mental, neurological and substance use conditions designed for use by primary and community health staff in low- and middle-income countries. The first edition of the mental health Gap Action Program-Intervention Guide has been implemented in over 100 countries. An updated version was launched in 2016 with new sections and updated evidence-based guidance. The mental health Gap Action Program-Intervention Guide v2.0 consists of eight modules addressing priority conditions (i.e. depression, psychoses, epilepsy, child and adolescent mental and behavioural disorders, dementia, disorders due to substance use, self-harm/suicide and conditions related to extreme stress). The guide provides an overview of common presentations for each condition followed by detailed guidance for assessment, management (including referral to specialist care) and follow-up.
The E-mental health Gap Action Program Intervention guide in Low and middle-income countries: proof-of-concept for Impact and Acceptability (Emilia) project seeks to re-address the treatment gap by developing a potentially practicable way for primary health care staff to monitor and treat people with mental illness according to evidence-based guidelines. The project is comprised of three phases: (1) development of an adapted e-mental health Gap Action Program intervention guide, (2) feasibility testing, and (3) knowledge transfer and future work.
Objectives
Emilia aims to test the feasibility of an electronic version of the mental health Gap Action Program-Intervention Guide v2.0 and trial procedures for the future evaluation of a large-scale trial, which would evaluate differences in depression detection between facilities using e-mental health Gap Action Program vs. paper mental health Gap Action Program. The objectives of this feasibility study, in preparation for a future trial, include the following:
- To evaluate the feasibility and acceptability of primary care mental health services utilizing the e-mental health Gap Action Program-Intervention Guide for training, supervision, and delivery of care [primary objective];
- To determine recruitment and retention rates for primary care workers and patients;
- To establish the acceptability and feasibility of assessing primary health worker and patient outcomes;
- To assess ethics and safety procedures using adverse event reporting;
- To describe depression detection rates in primary health clinics; and
- To describe depression treatment outcomes in primary health clinics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| paper mental health Gap Action Program-Intervention Guide | Active comparator | Other: paper-based version of mental health Gap Action Program-Intervention GuideThis 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. |
| digital mental health Gap Action Program-Intervention Guide | Experimental | Other: digital version of the mental health Gap Action Program-Intervention GuideThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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);
Key exclusion criteria (2 listed)
- Primary Care Health Workers: No exclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paper-based version of mental health Gap Action Program-Intervention GuideA paper-based guide for diagnosis and management of mental disorders in primary care. | Other | paper mental health Gap Action Program-Intervention Guide |
| digital version of the mental health Gap Action Program-Intervention GuideA digital guide and client data entry tool for diagnosis and management of mental disorders in primary care. | Other | digital mental health Gap Action Program-Intervention Guide |
Primary outcome
Mental Health Gap Action Programme Depression Diagnosis Tool
Time frame: Three months post training
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
37 secondary outcomes
Mental Health Gap Action Programme Depression Diagnosis Tool
Time frame: One month prior to training
Patient health questionnaire 9
Time frame: One month prior to training
Patient health questionnaire 9
Time frame: Three months post training
Patient health questionnaire 9
Time frame: Six months post training
World Health Organization Disability Assessment Schedule
Time frame: One month pre training
World Health Organization Disability Assessment Schedule
Time frame: Three months post training
World Health Organization Disability Assessment Schedule
Time frame: Six months post training
Mental health gap action program knowledge assessment
Time frame: One day pre training
Mental health gap action program knowledge assessment
Time frame: One day post training
Mental health gap action program knowledge assessment
Time frame: Three months post training
Mental health gap action program knowledge assessment
Time frame: Eight months post training
Enhancing Assessment of Common Therapeutic Factors
Time frame: One day pre training
Enhancing Assessment of Common Therapeutic Factors
Time frame: One day post training
Enhancing Assessment of Common Therapeutic Factors
Time frame: Three months post training
Enhancing Assessment of Common Therapeutic Factors
Time frame: Eight months post training
Social Distance Scale
Time frame: One day pre training
Social Distance Scale
Time frame: One day post training
Social Distance Scale
Time frame: Three months post training
Social Distance Scale
Time frame: Eight months post training
Enhancing Assessment of Common Therapeutic Factors - patient version
Time frame: One month pre training
Enhancing Assessment of Common Therapeutic Factors - patient version
Time frame: Three months post training
Enhancing Assessment of Common Therapeutic Factors - patient version
Time frame: Six months post training
Acceptability of Intervention Measure
Time frame: Three months post training
Acceptability of Intervention Measure
Time frame: Eight months post training
Acceptability of Intervention Measure - patient version
Time frame: Six months post training
Feasibility of Intervention Measure
Time frame: Three months post training
Feasibility of Intervention Measure
Time frame: Eight months post training
Intervention Appropriateness Measure
Time frame: Three months post training
Intervention Appropriateness Measure
Time frame: Eight months post training
Intervention Appropriateness Measure - patient version
Time frame: Six months post training
Organizational Readiness for Implementing Change
Time frame: One day pre training
Normalization Measure Development
Time frame: Eight months post-training
Perceptions of supervisory support scale
Time frame: Eight months post-training
Depression Attitudes Questionnaire
Time frame: One day pre training
Depression Attitudes Questionnaire
Time frame: One day post training
Depression Attitudes Questionnaire
Time frame: One month post training
Depression Attitudes Questionnaire
Time frame: Three months post training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 40408108Kohrt 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.
- Derived from this study: PubMed 34128819Taylor 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.
- Individual participant dataSharing planned: Yes. An individual participant data sharing plan will address both primary care health worker and patient data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Thornicroft, MD, PhD principal investigator
King's College London
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paper-based version of mental health Gap Action Program-Intervention Guide and digital version of the mental health Gap Action Program-Intervention Guide in people with Depression, run by George Washington University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Gap Action Programme Depression Diagnosis Tool (time frame: Three months post training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522453, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.