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

Background There is a growing global need for scalable approaches to training and supervising primary care workers (PCWs) to deliver mental health services. Over the past decade, the World Health Organization Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) and associated training and implementation guidance have been disseminated to more than 100 countries. On the basis of the opportunities provided by mobile technology, an updated electronic Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG) is now being developed along with a clinical dashboard and guidance for the use of mobile technology in supervision. Objective This study aims to assess the feasibility, acceptability, adoption, and other implementation parameters of the e-mhGAP-IG for diagnosis and management of depression in 2 lower-middle-income countries (Nepal and Nigeria) and to conduct a feasibility cluster randomized controlled trial (cRCT) to evaluate trial procedures for a subsequent fully powered trial comparing the clinical effectiveness and cost-effectiveness of the e-mhGAP-IG and remote supervision with standard mhGAP-IG implementation. Methods A feasibility cRCT will be conducted in Nepal and Nigeria to evaluate the feasibility of the e-mhGAP-IG for use in depression diagnosis and treatment. In each country, an estimated 20 primary health clinics (PHCs) in Nepal and 6 PHCs in Nigeria will be randomized to have their staff trained in e-mhGAP-IG or the paper version of mhGAP-IG v2.0. The PHC will be the unit of clustering. All PCWs within a facility will receive the same training (e-mhGAP-IG vs paper mhGAP-IG). Approximately 2-5 PCWs, depending on staffing, will be recruited per clinic (estimated 20 health workers per arm in Nepal and 15 per arm in Nigeria). The primary outcomes of interest will be the feasibility and acceptability of training, supervision, and care delivery using the e-mhGAP-IG. Secondary implementation outcomes include the adoption of the e-mhGAP-IG and feasibility of trial procedures. The secondary intervention outcome—and the primary outcome for a subsequent fully powered trial—will be the accurate identification of depression by PCWs. Detection rates before and after training will be compared in each arm. Results To date, qualitative formative work has been conducted at both sites to prepare for the pilot feasibility cRCT, and the e-mhGAP-IG and remote supervision guidelines have been developed. Conclusions The incorporation of mobile digital technology has the potential to improve the scalability of mental health services in primary care and enhance the quality and accuracy of care. Trial Registration ClinicalTrials.gov NCT04522453; https://clinicaltrials.gov/ct2/show/NCT04522453. International Registered Report Identifier (IRRID) PRR1-10.2196/24115

[1]  P. Pokhrel,et al.  Perception of healthcare workers on mobile app-based clinical guideline for the detection and treatment of mental health problems in primary care: a qualitative study in Nepal , 2021, BMC Medical Informatics and Decision Making.

[2]  M. Jordans,et al.  Impact of a district mental health care plan on suicidality among patients with depression and alcohol use disorder in Nepal , 2020, PloS one.

[3]  V. Patel,et al.  Community-, facility-, and individual-level outcomes of a district mental healthcare plan in a low-resource setting in Nepal: A population-based evaluation , 2019, PLoS medicine.

[4]  F. Mair,et al.  Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT) , 2018, BMC Medical Research Methodology.

[5]  Elizabeth Murray,et al.  Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT) , 2018, BMC Medical Research Methodology.

[6]  J. Nakku,et al.  How competent are non-specialists trained to integrate mental health services in primary care? Global health perspectives from Uganda, Liberia, and Nepal , 2018, International review of psychiatry.

[7]  N. Luitel,et al.  Building back better? Taking stock of the post-earthquake mental health and psychosocial response in Nepal , 2018, International Journal of Mental Health Systems.

[8]  M. Jordans,et al.  Prevalence and correlates of depression and alcohol use disorder among adults attending primary health care services in Nepal: a cross sectional study , 2018, BMC Health Services Research.

[9]  A. Adewuya,et al.  Current prevalence, comorbidity and associated factors for symptoms of depression and generalised anxiety in the Lagos State Mental Health Survey (LSMHS), Nigeria. , 2018, Comprehensive psychiatry.

[10]  G. Thornicroft,et al.  Service user and caregiver involvement in mental health system strengthening in low- and middle-income countries: a cross-country qualitative study , 2017, Epidemiology and Psychiatric Sciences.

[11]  Deborah E. White,et al.  Thematic Analysis , 2017 .

[12]  Dan J Stein,et al.  Global, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016 , 2017, Lancet.

[13]  Caitlin N. Dorsey,et al.  Psychometric assessment of three newly developed implementation outcome measures , 2017, Implementation Science.

[14]  M. Jordans,et al.  Treatment gap and barriers for mental health care: A cross-sectional community survey in Nepal , 2017, PloS one.

[15]  F. Schultze-Lutter,et al.  Association between mental health-related stigma and active help-seeking: Systematic review and meta-analysis , 2017, British Journal of Psychiatry.

[16]  R. Kessler,et al.  Undertreatment of people with major depressive disorder in 21 countries , 2017, British Journal of Psychiatry.

[17]  A. Adewuya,et al.  Prevalence and associated factors for suicidal ideation in the Lagos State Mental Health Survey, Nigeria , 2016, BJPsych Open.

[18]  R. Scott,et al.  Impact of simple conventional and Telehealth solutions on improving mental health in Afghanistan , 2016, Journal of telemedicine and telecare.

[19]  G. Thornicroft,et al.  Does the United Nations care about mental health? , 2016, The lancet. Psychiatry.

[20]  M. Jordans,et al.  Detection of depression in low resource settings: validation of the Patient Health Questionnaire (PHQ-9) and cultural concepts of distress in Nepal , 2016, BMC Psychiatry.

[21]  Muirne C. S. Paap,et al.  Using the Three-Step Test Interview to understand how patients perceive the St. George’s Respiratory Questionnaire for COPD patients (SGRQ-C) , 2015, Quality of Life Research.

[22]  V. Patel,et al.  Therapist competence in global mental health: Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. , 2015, Behaviour research and therapy.

[23]  N. Upadhaya,et al.  Mental health care in Nepal: current situation and challenges for development of a district mental health care plan , 2015, Conflict and Health.

[24]  A. Mann,et al.  The development and psychometric properties of a measure of clinicians’ attitudes to depression: the revised Depression Attitude Questionnaire (R-DAQ) , 2015, BMC Psychiatry.

[25]  J. George,et al.  Confusion: delirium and dementia - a smartphone app to improve cognitive assessment , 2015, BMJ quality improvement reports.

[26]  V. Patel,et al.  Experiences of stigma and discrimination of people with schizophrenia in India , 2014, Social science & medicine.

[27]  Irwanto,et al.  The Cultural Validation of Two Scales to Assess Social Stigma in Leprosy , 2014, PLoS neglected tropical diseases.

[28]  Richard J. Goscha,et al.  The Perceptions of Supervisory Support Scale , 2014, Administration and Policy in Mental Health and Mental Health Services Research.

[29]  V. Patel,et al.  The global prevalence of common mental disorders: a systematic review and meta-analysis 1980-2013. , 2014, International journal of epidemiology.

[30]  Bryan J Weiner,et al.  Organizational readiness for implementing change: a psychometric assessment of a new measure , 2014, Implementation Science.

[31]  Pip Divall,et al.  The use of personal digital assistants in clinical decision making by health care professionals: A systematic review , 2013, Health Informatics J..

[32]  Norman Sartorius,et al.  Global pattern of experienced and anticipated discrimination reported by people with major depressive disorder: a cross-sectional survey , 2013, The Lancet.

[33]  Graham Thornicroft,et al.  Evidence-Based Guidelines for Mental, Neurological, and Substance Use Disorders in Low- and Middle-Income Countries: Summary of WHO Recommendations , 2011, PLoS medicine.

[34]  S. Thapa,et al.  Perceived needs, self-reported health and disability among displaced persons during an armed conflict in Nepal , 2011, Social Psychiatry and Psychiatric Epidemiology.

[35]  Alicia C. Bunger,et al.  Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda , 2010, Administration and Policy in Mental Health and Mental Health Services Research.

[36]  Tim Brown,et al.  Design Thinking for Social Innovation , 2010 .

[37]  B. Weiner,et al.  Implementation Science a Theory of Organizational Readiness for Change , 2009 .

[38]  M. Jordans,et al.  Brief Multi-Disciplinary Treatment for Torture Survivors in Nepal: a Naturalistic Comparative Study , 2009, The International journal of social psychiatry.

[39]  Josep Maria Haro,et al.  Use of mental health services for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys , 2007, The Lancet.

[40]  G. Willis,et al.  Research Synthesis: The Practice of Cognitive Interviewing , 2007 .

[41]  O. O. Afolabi,et al.  Validity of the patient health questionnaire (PHQ-9) as a screening tool for depression amongst Nigerian university students. , 2006, Journal of affective disorders.

[42]  V. Braun,et al.  Using thematic analysis in psychology , 2006 .

[43]  Christopher Donoghue,et al.  Updating the Bogardus social distance studies: a new national survey , 2005 .

[44]  R. Kessler,et al.  Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys. , 2004, JAMA.

[45]  R. Spitzer,et al.  The PHQ-9 , 2001, Journal of General Internal Medicine.

[46]  A. Farmer,et al.  The Composite International Diagnostic Interview. An epidemiologic Instrument suitable for use in conjunction with different diagnostic systems and in different cultures. , 1988, Archives of general psychiatry.

[47]  James Frank,et al.  The Social Rejection of Former Mental Patients: Understanding Why Labels Matter , 1987, American Journal of Sociology.

[48]  R. Hambleton,et al.  [International Test Commission Guidelines for test translation and adaptation: second edition]. , 2013, Psicothema.

[49]  T. B. Üstün,et al.  Measuring health and disability : manual for WHO Disability Assessment Schedule : WHODAS 2.0 , 2010 .

[50]  N. Upadhaya,et al.  Political violence and mental health: a multi-disciplinary review of the literature on Nepal. , 2010, Social science & medicine.

[51]  Bruce G. Link,et al.  Measuring mental illness stigma. , 2004, Schizophrenia bulletin.

[52]  R. Spitzer,et al.  The PHQ-9: validity of a brief depression severity measure. , 2001, Journal of general internal medicine.