Title: ENHANCE: Scaling-up Care for Perinatal Depression through Technological Enhancements to the ‘Thinking Healthy Programme’
Funder: Department of Health and Social Care

Abstract: Background Perinatal depression affects about one in 4 women in South Asia and has huge human and economic costs. Effective and culturally adapted psychological interventions are available but the vast majority remain untreated because of overburdened health systems and lack of specialist supervisors. Digital technologies are increasingly being used in many areas of health care, but there is no Application that can assist lay-therapists to deliver an evidence-based intervention effectively in low-income settings. Aims and objectives We aim to: a) Develop and evaluate a digital Application (App) to facilitate delivery of a World Health Organisation-approved Cognitive Therapy based intervention, the Thinking Healthy Programme, through lay-therapists in Pakistan. b) Build implementation research capacity in 4 South Asian countries, Pakistan, Nepal, Bangladesh and Sri Lanka, to facilitate scale-up of the intervention in their settings. Methods The research component will be carried out in Pakistan in two phases: a) Formative phase (18 months): We already have extensive knowledge of the content, methods of training, supervision and delivery of the Thinking Healthy Programme which was developed by our team. Building on this knowledge, we will develop the App employing a Human-Centred Design, which places end-users at the heart of the process in 3 iterative steps: i) identifying the requirements of lay-therapists and mothers through in-depth interviews and focus group discussions; ii) testing multiple prototypes on selected users, and; iii) testing the final prototype in actual conditions. b) Evaluation phase (30 months): We will then compare the effectiveness and cost-effectiveness of the App-assisted intervention with enhanced usual care using a cluster randomised control trial (cRCT) design. We will randomly assign 40 village clusters (1:1) to provide the App-assisted Thinking Healthy Programme or Enhanced Usual Care (control group) to the participants within clusters. The participants will be pregnant women aged 18 years or older who score at least 10 on the Patient Health Questionnaire-9 (PHQ-9). The sample size will be 560 women. Participants will be evaluated at 3 and 6 months after childbirth. The primary outcomes will be the severity of depressive symptoms (assessed by PHQ-9 score) and the prevalence of remission (defined as a PHQ-9 score of less than 5) 3 months after childbirth, assessed by researchers masked to treatment allocations. Outcomes will be analysed by intention to treat, adjusting for covariates that will be defined a priori. The capacity building component will operate in the 3 collaborating countries (Nepal, Bangladesh, Sri Lanka) through a Research Fellowship scheme for early career researchers. They will be trained to undertake research projects in areas which are thought to be critical for implementation in their respective countries. Anticipated impact and Dissemination In Pakistan, we are working closely with the Ministry of Health to scale-up the Thinking Healthy programme nationally. The research will feed directly into this national programme. Globally, we will work closely with the World Health Organization to incorporate our findings into the revised version of the Thinking Healthy Programme which will be disseminated to all member countries through the WHO s flagship mental health gap action programme.

Lay abstract: a) Background and aims of the programme Perinatal depression affects about one in 4 women in South Asia and has huge human and economic costs. It can be treated effectively with talking therapies . However, the vast majority of women in low-income countries remain untreated because of overburdened health systems and lack of mental-health specialists. Digital technologies are increasingly being used in many areas of health care, but there is no Application that can assist lay-therapists to deliver an evidence-based intervention effectively in low-income settings. We aim to: Develop and evaluate a digital Application (App) to facilitate delivery of a WHO-approved talking therapy , the Thinking Healthy Programme, through lay-women in Pakistan. Build implementation research capacity in 4 South Asian countries, Pakistan, Nepal, Bangladesh and Sri Lanka, to facilitate scale-up of the intervention in their settings. b) Design and methods used The research component will be carried out in Pakistan in two phases: Formative phase (18 months): We have extensive knowledge of the content, methods of training, supervision and delivery of the Thinking Healthy Programme which was developed by our team. Building on this knowledge, we will develop the App employing a Human-Centred Design, which places end-users at the heart of the process in 3 iterative steps: i) identifying the requirements of lay-therapists and mothers; ii) testing multiple prototypes on selected users, and; iii) testing the final prototype in actual conditions. Evaluation phase (30 months): We will then compare the effectiveness and value-for-money of the App-assisted intervention with enhanced usual care. Participants from randomly picked villages, who score highly on a depression questionnaire will receive, one or the other intervention. We will then assess both groups at 3 and 6 months after childbirth for symptoms of depression and other health outcomes in the mothers and infants. We will interview some participants in more detail to understand the facilitators and barriers to the new way of intervention delivery. We will determine the costs associated with the programme to evaluate its value-for-money . The capacity building component will operate in the 4 collaborating countries (Pakistan, Nepal, Bangladesh, Sri Lanka) through a Research Fellowship scheme for middle/junior level scientists. They will be trained to undertake research projects in areas which are thought to be critical for implementation. Public involvement We plan to raise public awareness of perinatal depression and what can be done about it through our well-established South Asian Hub for Advocacy, Research, and Education in mental health, operating in all four countries since 2012. Dissemination We will work closely with the World Health Organization to incorporate our findings into the revised version of the Thinking Healthy Programme which will be disseminated to all member countries through the WHO s flagship mental health gap action programme.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;REPRODUCTIVE HEALTH AND CHILDBIRTH