Background
The prevalence of maternal depression in low and middle income countries (LMICs) ranges between 18 and 25 % [
1]. In Pakistan the mean prevalence of depression is 33 %, with women being at a greater risk than men [
2]. Untreated depression in women is of particular concern due to its adverse effects on the health of the mother and infant. Maternal depression, is linked with pre-term birth [
3], low birth weight [
3], under-nutrition in the first year of life [
4], higher rates of diarrhea [
5], and early cessation of breastfeeding [
6]. Maternal depression has a profound adverse trans-generational impact [
6]. The economic burden of depression in pregnant and postnatal women not only includes the cost of treating depression, but the cost of complications, such as pre-term birth and low birth weight [
3]. Children of depressed mothers also have higher lifetime medical spending due to the adverse effects of postpartum depression on the child’s own health [
7]. The scope and magnitude of the problem is magnified in humanitarian crisis settings [
8].
Evidence-based interventions for depression exist [
9] but there is slow progress in the “know-do gap”: the gap between what is known and what gets implemented in LMICs [
10,
11]. The burden of illness can be reduced by narrowing this gap through scale-up of proven interventions. The Thinking Healthy Program (THP) is a culturally adapted [
12] cognitive behaviour therapy (CBT)-based psychosocial intervention for maternal depression, which relies on CHWs called Lady Health Workers (LHWs) for its delivery [
12,
13]. In a recent meta-analysis [
9], THP was shown to have one of the largest effect sizes and has been adopted by the World Health Organization (WHO) for global dissemination through its mental health Gap Action Program (mhGAP) [
14].
The major issues in scaling up the coverage of health interventions include the costs, equity and quality concerns and service delivery issues [
15]. In the context of scaling up, the supply of additional human resources is a major barrier [
16]. Another challenge in the scaling up of this evidence-based intervention is the provision of training and supervision at scale, especially in post-conflict areas with weak health systems. We aim to meet this challenge by providing technology-based solutions to training and supervision. Building on our previous work in this area, we aim to develop a Technology-assisted Cascade Training and Supervision for the THP (TACTS-THP) system that includes a tablet-based multimedia manual, using “Avatar” characters, allowing standardized training to be delivered without the need for a specialist trainer; and a cascade training model whereby specialists supervise the LHW program supervisors from a distance, who in turn supervise the LHWs as part of their routine. The cascade training has been found to be effective in training non-specialists to deliver mental health interventions [
17].
The LHW program covers 85 % of Pakistan’s rural population by utilizing 115,000 LHWs. If we are able to provide a technological solution to their training and supervision, LHWs have the potential to provide treatment to one in four women with perinatal depression in rural Pakistan. The THP-TACTS system will be widely disseminated. If proven effective the technology has the potential to be replicated for scale-up of other mental health interventions.
Primary objective
The primary objective of this trial is to demonstrate whether LHWs in Pakistan attain the same competence level for delivering THP to depressed mothers if they are trained with the help of technology versus training by specialists.
Secondary objective
The secondary objectives of this trial are the assessment of feasibility and acceptability of the technological training and supervision approach by LHWs and community.
Hypothesis
LHWs trained through TACTS will be as competent in the skills needed to deliver THP as those trained by specialists.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
The protocol was initially developed by SZ and feedback was provided by SS, AR, NA, JM, and SUH. SZ and SS are the PIs for this study. JM provided advice on statistical analysis. NA, along with PA and HN are responsible for the development and design of the Technology Manual with feedback from AR, SZ, SS and SUH. SZ and SS are responsible for monitoring. All authors reviewed the final manuscript prior to submission. All authors read and approved the final manuscript.
SZ has been the Head of Centre of Excellence in Maternal, Neonatal Child Health (MNCH) at the Health Services Academy since 2012. She has experience in working with the Pakistan Government and LHW program. SZ has more than 20 years of work experience in maternal health and 7 years of management experience of heading an NGO working for maternal and child health in Pakistan. She has a fellowship in obstetrics and gynecology, a diploma in epidemiology from the London School of Hygiene and Tropical Medicine and a PhD from the University of Liverpool. SZ is co-PI for a cluster randomized controlled trials (CRCT) on a complex intervention including maternal psychosocial wellbeing for the rural community, Sustainable Program Incorporating Nutrition & Games (SPRING) in Pakistan, which is a Welcome Trust, UK-funded multi-country collaborative program.
SS is the lead of the trials unit at the Human Development Research Foundation (HDRF). He has coordinated and supervised a number of community-based research projects in rural Pakistan including the THP intervention trial. He was the co-PI of a district-level CRCT to test a maternal-focused psycho-educational approach to promote exclusive breastfeeding in infants funded by USAID. He has established rural community research sites and has developed linkages with the Ministry of Health (MOH) Pakistan, the LHW program, NGOs working in public health and national academic institutions. He is an honorary associate professor of psychiatry at the Institute of Psychiatry, Pakistan (IoP). IoP is the WHO’s Collaborating Centre for Mental Health Research and Training for the Eastern Mediterranean Regional Office (EMRO) region.
JM is a social epidemiologist whose research is focused on the psychosocial determinants of mental health across the life course. Her employment of rigorous methodologies in study design, implementation, and analysis of data arise from her psychiatric epidemiology training and prior experience with population based-studies. She is currently the PI of an NIH-funded study examining mechanisms of the transmission of psychopathology risk across generations in multi-generational households in Sri Lanka. Dr. Maselko’s previous work in this region includes research with women in Bangladesh and an on-going perinatal depression study in India.
SUH is a medical doctor and leads the implementation research unit at the Human Development Research Foundation. He is a doctoral fellow in psychiatry at the University of Liverpool, UK. He is experienced in coordinating randomized controlled trials including trials in post-conflict settings. He is the key researcher in the Grand Challenges Canada-funded FaNs for children with developmental disorders development and pilot project, coordinating all aspects of this study, including development of the TACTS system, fieldwork, training and supervision. He is the project lead (along with Siham Sikander) for the FaNs for children with developmental disorders project Transition to Scale (TTS) cluster RCT, funded by Grand Challenges Canada in collaboration with the University of Liverpool, UK and the WHO, Geneva. He is the co-investigator (with Atif Rahman and Mark van Ommeren) on two randomized controlled trials to evaluate the WHO-focused project for the population affected by the humanitarian crisis in Northern Pakistan.
AR was the PI on the original THP study. He is a world-renowned expert in perinatal depression and has led the formative research on non-pharmacological treatments for maternal depression in low-resource settings. He has been PI on numerous, internationally funded projects, is an advisor to the WHO and UNICEF (ECD Group), and works closely with the MOH in Pakistan to implement evidence-based policy and build capacity of local researchers.