Clinical trial NCT04522453: E-MhGAP Intervention Guide in Low- and Middle-income Countries: Proof-of-concept for Impact and Acceptability
Official title: E-MhGAP Intervention Guide in Low- and Middle-income Countries: Proof-of-concept for Impact and Acceptability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Primary care
Competence
Mobile health
Mental health
Low- and middle-income countries
Training
Supervision
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: King's College London
name: Duke University
name: Transcultural Psychosocial Organization Nepal
name: University of Ibadan
name: World Health Organization
name: Medical Research Council
First posted: 2020-08-21
Enrollment: 3351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility cluster randomized controlled trial
Primary purpose: DIAGNOSTIC

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.

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:

1. 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 \[primary objective\];
2. To determine recruitment and retention rates for primary care workers and patients;
3. To establish the acceptability and feasibility of assessing primary health worker and patient outcomes;
4. To assess ethics and safety procedures using adverse event reporting;
5. To describe depression detection rates in primary health clinics; and
6. To describe depression treatment outcomes in primary health clinics.

Eligibility criteria: Inclusion Criteria:

* 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);

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mental Health Gap Action Programme Depression Diagnosis Tool
timeFrame: Three months post training
Secondary outcomes:
measure: Mental Health Gap Action Programme Depression Diagnosis Tool
timeFrame: One month prior to training
measure: Patient health questionnaire 9
timeFrame: One month prior to training
measure: Patient health questionnaire 9
timeFrame: Three months post training
measure: Patient health questionnaire 9
timeFrame: Six months post training
measure: World Health Organization Disability Assessment Schedule
timeFrame: One month pre training
measure: World Health Organization Disability Assessment Schedule
timeFrame: Three months post training
measure: World Health Organization Disability Assessment Schedule
timeFrame: Six months post training
measure: Mental health gap action program knowledge assessment
timeFrame: One day pre training
measure: Mental health gap action program knowledge assessment
timeFrame: One day post training
measure: Mental health gap action program knowledge assessment
timeFrame: Three months post training
measure: Mental health gap action program knowledge assessment
timeFrame: Eight months post training
measure: Enhancing Assessment of Common Therapeutic Factors
timeFrame: One day pre training
measure: Enhancing Assessment of Common Therapeutic Factors
timeFrame: One day post training
measure: Enhancing Assessment of Common Therapeutic Factors
timeFrame: Three months post training
measure: Enhancing Assessment of Common Therapeutic Factors
timeFrame: Eight months post training
measure: Social Distance Scale
timeFrame: One day pre training
measure: Social Distance Scale
timeFrame: One day post training
measure: Social Distance Scale
timeFrame: Three months post training
measure: Social Distance Scale
timeFrame: Eight months post training
measure: Enhancing Assessment of Common Therapeutic Factors - patient version
timeFrame: One month pre training
measure: Enhancing Assessment of Common Therapeutic Factors - patient version
timeFrame: Three months post training
measure: Enhancing Assessment of Common Therapeutic Factors - patient version
timeFrame: Six months post training
measure: Acceptability of Intervention Measure
timeFrame: Three months post training
measure: Acceptability of Intervention Measure
timeFrame: Eight months post training
measure: Acceptability of Intervention Measure - patient version
timeFrame: Six months post training
measure: Feasibility of Intervention Measure
timeFrame: Three months post training
measure: Feasibility of Intervention Measure
timeFrame: Eight months post training
measure: Intervention Appropriateness Measure
timeFrame: Three months post training
measure: Intervention Appropriateness Measure
timeFrame: Eight months post training
measure: Intervention Appropriateness Measure - patient version
timeFrame: Six months post training
measure: Organizational Readiness for Implementing Change
timeFrame: One day pre training
measure: Normalization Measure Development
timeFrame: Eight months post-training
measure: Perceptions of supervisory support scale
timeFrame: Eight months post-training
measure: Depression Attitudes Questionnaire
timeFrame: One day pre training
measure: Depression Attitudes Questionnaire
timeFrame: One day post training
measure: Depression Attitudes Questionnaire
timeFrame: One month post training
measure: Depression Attitudes Questionnaire
timeFrame: Three months post training
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Transcultural Psychosocial Organization Nepal
city: Ibadan
country: Nigeria
facility: University of Ibadan
state: Oyo State
Study officials:
affiliation: King's College London
name: Graham Thornicroft, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.