Title: Developing and evaluating an adapted behavioural activation intervention for people with depression and diabetes in South Asia
Funder: Department of Health and Social Care

Abstract: Background Health care systems in low- and middle-income countries face the growth of mental and physical multimorbidity. People with long-term physical health conditions, such as diabetes, have a 2-3 fold increased risk of depression. Outcomes for comorbid depression and diabetes are significantly worse for both conditions. Diabetes is rapidly increasing, particularly in South Asia where depression in type 2 diabetes represents the largest combined mental and non-communicable disease burden. A joint approach to care is needed using a scalable intervention to recognise and treat depression, integrated with diabetes care. &ldquo;Behavioural Activation&rdquo; (BA) is a relatively simple, effective and culturally portable psychological therapy for depression, which can be delivered by non-specialists. Aims and objectives We aim to develop and test a culturally appropriate approach to the recognition and treatment of depression in people with diabetes in Bangladesh and Pakistan based on BA. In this 4-year programme, we will: Develop a culturally relevant, scalable intervention delivered by non-specialists, integrated within diabetes care (DiaDeM) Use decision modelling and value of information analysis to inform the design of a trial of DiaDeM Test the feasibility of DiaDeM, and develop procedures for a full trial evaluation Evaluate the clinical and cost-effectiveness of DiaDeM versus optimised usual care Estimate the economic impacts of depression and diabetes multimorbidity. Methods We will use interviews, literature review, consensus development and co-design to adapt BA for delivery alongside diabetes care in Bangladesh and Pakistan. A feasibility trial of DiaDeM will assess acceptability and whether proposed recruitment, randomisation and data collection procedures are feasible. We will conduct a multi-centre pragmatic individually randomised controlled trial with 294 participants in secondary care diabetes services from each country, comparing DiaDeM with optimised usual care for people with depression and type 2 diabetes. The primary outcome will be depression severity at 6 months (using PHQ-9); secondary outcomes include diabetes self-management, glycaemic control, health-related quality of life, and depression severity at 12 months. Cost-effectiveness will be assessed from alternative perspectives, reflecting the expenditure on public and private health care and out of pocket payments. We will analyse the data using linear regression, adjusting for baseline scores, stratification factors and other important covariables. A mixed methods process evaluation will aid understanding of the causal mechanisms, implementation and scale-up. Community Panels comprising people with mental-physical illness and organisations that advocate for them will be fully involved at all stages. We will also build capability in applied multimorbidity research and policymaking through experiential learning, doctoral fellowships, bespoke training and Research-Policy Forums . Anticipated impact and dissemination Potential impact will be maximised by an Impact Working Group including the Community Panels, healthcare practitioners and policy makers. If effective, it will plan the integration of the intervention into routine care and disseminate findings using social media, websites, reports, conferences and newspaper and journal articles. DiaDeM has potential to improve mental and physical health, reduce inequalities and stigma for vulnerable groups and provide economic benefit. Building on our existing collaborations, the programme will further enhance capacity in applied mental-physical multimorbidity research and policymaking.

Lay abstract: People with long-term physical health conditions, such as diabetes, are more likely to experience depression. Diabetes is a growing global problem, particularly in South Asia. When people have depression and diabetes, outcomes for both are worse, resulting in poorer health, quality of life, earlier deaths, and increased costs for individuals, families and healthcare services. We will develop and test a culturally appropriate treatment for depression in people with diabetes in Bangladesh and Pakistan. This will be based on a relatively simple psychological talking treatment called &ldquo;Behavioural Activation&rdquo; (BA), that has been shown to treat depression effectively and can be delivered by non-specialist health workers. BA helps people make the link between what they do and how they feel and supports them to make changes to improve their health. Building on our established collaborations, we will: 1) Modify BA to fit the cultural and economic context, by working with people with experience of depression and diabetes, their families, healthcare professionals and policymakers, individually and in groups, to design and refine the BA treatment, in a series of workshops. 2) Test (and if needed, further refine) the modified BA treatment in a small-scale trial to see if it is acceptable and can be delivered successfully and learn how best to collect the information we will need in the next stage of research. 3) Evaluate the modified BA intervention using a large-scale randomised controlled trial, in which a group of people with diabetes and depression will be randomly allocated to receive either BA or usual care. We will find out whether BA improves depression, self-care of diabetes, blood sugar levels, physical health and quality of life, and if it offers value for money. 4) Examine what it means to have both depression and diabetes from an economic perspective e.g. how much time and money patients and carers spend in accessing care. This information will help policymakers in their decisions about provision of appropriate healthcare. Alongside the research, we will develop expertise in the research team and local policymakers to make use of research findings in practice and to kickstart further research in this area. We have established Community Panels comprising people with mental-physical illness and organisations that advocate for them. Panels will be fully involved in the programme, providing advice on the conduct of studies and helping to interpret and publicise findings. Our findings will be of value to people with depression and diabetes, their families, health professionals, policymakers and researchers. We will develop detailed plans together with Community Panels and policymakers to integrate the intervention into routine care (if it is shown to be effective) and to disseminate findings using social media, websites, reports, conferences and newspaper and journal articles.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;METABOLIC AND ENDOCRINE