Background
Health systems around the globe are facing enormous challenges, and these are particularly apparent in LMICs [
1‐
4]. High prevalence of mental disorders, a reliance on limited and unevenly distributed specialists, and neglect of adequate investment in resources allocated to mental health have prevented between 76-85% of people living with mental health problems in LMICs from receiving any treatment [
4‐
9]. This treatment gap, which is on the rise in LMICs, points to the dire need of developing proximity mental health services for a population “now among the most neglected and vulnerable throughout the world” [
10].
International efforts are currently invested in reforms that build system capacity in primary and community-based settings for an number of reasons [
8,
11‐
13]. First, there are proven user and system benefits of receiving care in such settings. These include: increased user and family satisfaction with services; reduced service costs; increased access to services for a wider population; and decreased stigmatized care [
9,
14‐
17]. Second, current reforms target primary and community-based care because improvements in mental health system capacity do not require highly specialized professionals [
7,
12,
18]. Contrary to wide-spread belief on delivering mental health services, most mental health problems can be effectively managed in non-specialized health settings by non-specialists through an approach called task-sharing [
2,
19‐
27]. Task-sharing is defined as “moving the primary provision of the mental health intervention from mental health specialists (e.g., psychiatrists, psychologists, Master level providers) to lay counselors (i.e., limited to no mental health training or experience)” [
25]. International efforts are assuming this approach because of its concordance with the realities of LMICs - it emphasizes the need to involve primary healthcare professionals and/or the lay workforce given the limited number and unequal distribution of mental health specialists [
5,
18,
24,
25,
28].
GPs have been targets of many task-sharing initiatives worldwide because they are ideally placed in the healthcare system [
29‐
31]. However, they often lack appropriate knowledge and skills to adequately detect, treat and manage mental health problems. To respond to this gap in knowledge, a number of mental health training programs targeting GPs have been developed and implemented worldwide. Such trainings contribute to health system reform in that “there is evidence that adequate training can reduce variations in provider behavior, improve fidelity, and ultimately increase the quality of service delivery” [
32]. Developing and implementing mental health trainings that seek to build capacity and further integrate mental health into routine general practice has also been identified as a priority in global mental health [
33].
It is important to note that questions regarding evidence on building mental health system capacity by offering training programs to non-specialized healthcare professionals, including GPs, often arise. First, findings are mainly from high-income countries (HICs) [
7,
26,
34] and do not concord with the realities of LMICs due to differing culture and context, preventing the uptake of relevant and useful knowledge in these settings [
34]. Therefore, generating appropriate and usable knowledge is an increasingly important research priority in global mental health [
7,
26,
34,
35]. Second, most mental health training programs are focused solely on evaluating effectiveness or efficacy using experimental trials such as RCTs, which are known to disregard contextual factors that might influence the uptake and use of knowledge, practice-level changes, system-level changes, and sustainability of an implemented program [
34,
36]. Therefore, implementation analysis is needed because it highlights how culture and context affect the successful implementation of an intervention within a dynamic environment, which can have a significant impact on desired training outcomes [
36]. Last, most mental health training programs are not designed in the form of a ‘package,’ where training is complimented with guidelines that seek to develop mental health policies and systems [
17,
26]. These guidelines are important because they can help decision-makers orchestrate and sustain reforms [
7,
26,
37].
In 2008, the WHO launched the mhGAP in response to these gaps in evidence on building mental health system capacity. The Programme aims to train non-specialists in mental health detection, treatment, and management, all the while complimenting training with discussions around implementation, as well as system and policy development [
26,
38]. In 2010, the mhGAP Intervention Guide (IG), currently in its second edition, was developed to encourage delivery of evidence-based interventions for what the WHO deems priority mental disorders [
2,
39,
40]. The guide was developed by systematically searching the literature on ways to effectively treat and manage mental disorders in non-specialized settings by non-specialists [
2]. Interventions included in the guide were also subject to international expert consultation [
2].
The mhGAP-IG is the current mental health training of choice around the world for a number of reasons. Unlike previous mental health trainings, the evidence is based on findings specifically from LMICs, as well as expert opinion from researchers, decision-makers, and healthcare professionals working within these countries [
26,
34,
39]. In addition, the mhGAP-IG was developed through international participatory consensus-based processes [
39]. Participatory processes are particularly important when developing training interventions for mental health seeing as “the classification system for mental disorders that will be satisfactory for primary care must capture the complexity of the range of presentations of psychological problems in that setting” [
39]. For the above mentioned reasons, the mhGAP-IG was chosen as the intervention for this trial.
The Tunisian Ministry of Health, in collaboration with the School of Public Health at the University of Montreal, the WHO office Tunisia, and the Montreal WHO-PAHO Collaborating Center for Research and Training in Mental Health (Douglas Mental Health University Institute), is interested in implementing an adapted version the mhGAP-IG in 2 governorates (i.e., Tunis and Sousse), in response to a country-wide health services reform that began in 2013. One of the main targets of this reform is to strengthen health system capacity by creating proximity health services [
41,
42]. This reorganization aims to: 1) promote the use of multidisciplinary teams in primary care settings; 2) valorize general medical practice; and 3) equip primary care practitioners in effective patient management [
42]. This reform is also discussed extensively to meet the needs of people living with mental health problems in Tunisia [
41].
Implementing a mental health training based on the mhGAP-IG (version 1.0) thus comes at an opportune time during the health systems reform in Tunisia. Although Tunisia is equipped with mental health services, they are mainly provided in the capital (through the only standing and overcrowded mental health hospital in the country) and along the coastline (through psychiatric units within regional hospitals), making the distribution of resources uneven and impeding on equal access to services [
43,
44]. In addition, Tunisia suffers from a shortage of mental health professionals, such as psychiatrists, psychologists, psychiatric nurses, and mental health social workers [
41,
43] also echoed in many other LMICs. Shortages of mental health specialists in Tunisia force non-specialists such as GPs to receive between 30–40% of mental health consultations, despite their limited ability to adequately detect, treat, and manage mental health problems in primary care [
41,
45].
Objectives
This trial aims to implement and evaluate an adapted version of the mhGAP-IG (version 1.0) offered to GPs in 2 governorates of Tunisia (i.e., Tunis and Sousse), in order to uncover important information regarding implementation process and study design, before country-wide implementation and evaluation. The main objective of the trial is divided into 3 phases:
Phase 1 aims to answer the following research question by conducting a systematic review: 1) What types of mental health training programs offered to GPs have been implemented and evaluated, and are they effective? This review, which to our knowledge has not yet been previously conducted, will: 1) help us gain a broader perspective on tested training outcomes, in order to inform this trial; 2) compliment already available findings on the mhGAP-IG; and 3) compare the effectiveness of a mental health training based on the mhGAP-IG (this trial) with previously implementing training programs in LMICs.
Phase 2 aims to answer the following research question by conducting a cluster RCT: 2) What is the potential value of building capacity in primary or community-based settings by training GPs in Tunis and Sousse (Tunisia) using the mhGAP-IG? Five specific modules from the mhGAP-IG (version 1.0) have been chosen by members of the Ministry of Health in Tunisia to reflect current and pressing needs: depression; psychosis; suicide/self-harm; alcohol use disorders; and drug use disorders. The main hypothesis of this cluster RCT is that the mental health training based on the mhGAP-IG will be clinically useful; will improve/increase GPs’ knowledge about disorders selected for training, attitudes towards mental illness, and perceived clinical self-efficacy; and will improve/increase rates of detection, treatment and management of mental illness. In addition, the cluster RCT will allow us to obtain crucial information on the design, namely the acceptability of delivering the mental health training as planned for the trial, as well as the estimated effect size and intra-cluster correlation (ICC) of a mental health training based on the mhGAP-IG. At the time this protocol was written and defended (June 2015), this information was not available.
Phase 3 aims to answer the following research question by multiple case study design: 3) How do contextual factors influence the successful implementation and expected outcomes of a mental health training based on the mhGAP-IG (version 1.0) offered to GPs in Tunis and Sousse (Tunisia)? This type of evaluation is referred to as Type III implementation analysis [
36] and is currently a priority in global mental health [
34].
Discussion
The purpose of this trial is to implement and evaluate a training based on the mhGAP-IG (version 1.0) offered to GPs in 2 Tunisian governorates (i.e., Tunis and Sousse), in order to uncover important information regarding implementation process and study design. Generated information will aid in country-wide implementation and evaluation. This training comes at an opportune time, given that Tunisia is currently undergoing a health services reform, one of its main objectives being to further develop proximity health services to address the mental health treatment gap in the country [
41,
42]. In addition, given the political unrest and economic hardships currently experienced in Tunisia, mental health issues are of great national concern. While Tunisia has a mental health system, the uneven distribution of services and deficits in training for staff cause significant barriers to accessible care [
41,
43].
This trial makes several practical contributions. First, its main focus is to train GPs in the detection, treatment and management of patients consulting for specific mental health problems in Tunis or Sousse, given their often limited capacity to address mental illness. Involvement of members of the Tunisian Ministry of Health in the implementation of this training program has prompted its inclusion under the national mandate of the Committee for Mental Health Promotion in Tunisia. A training under this Committee’s leadership has been dormant for years. In addition, this training aims to help further integrate mental health into primary care by training non-specialists in mental health. With GPs playing such an important role in the healthcare system, this training will help better utilize available resources in the country in order to target the mental health treatment gap.
This trial makes several contributions to the literature. To our knowledge, this is the first attempt to evaluate a mental health training program using a RCT design in Tunisia; implement a training based on the mhGAP-IG in Tunisia; and one of the first attempts to implement and evaluate a training based on the mhGAP-IG in a French-speaking nation. The trial will thus help build research capacity in Tunisia and more generally in LMICs, currently under-represented in the mental health literature [
7,
34]. This trial also compliments the effectiveness results with implementation analysis, a current priority in global mental health [
7,
26,
34]. Acknowledging factors that influence the successful implementation of a training program generates understanding on how context, especially within a health services reform such as the one currently underway in Tunisia, influences desired outcomes [
36].
Lessons learned from this trial (i.e., successes and challenges regarding implementation of the training and acceptability of the trial design) can also be of use to other LMICs interested in implementing and evaluating a mental health training program based on the mhGAP-IG; designing a cluster RCT to evaluate the mhGAP-IG; or exploring contextual factors that can influence the success of a training intervention and expected results in a low-resource setting.
Acknowledgements
The authors wish to thank: 1) members present during JS’s doctoral defense for their valuable comments on the protocol; 2) Benoît Mâsse, Ph.D. for his valuable input regarding the design and analysis of the trial; 3) Dr. Guido Sabatinelli, former WHO Representative in Tunisia, for his feedback on the training evaluation material and the administrative support provided by the WHO in Tunisia; and 4) Ann-Lise Guisset, Ph.D., for her feedback on the training evaluation material and support throughout the development of the project.