Improving mental health through integration with primary care in rural Karnataka: study protocol of a cluster randomized control trial

Abstract

BackgroundPeople who are diagnosed with both mental and chronic medical illness present unique challenges for the health care system. In resource-limited settings, such as rural India, people with depression and anxiety are often under-served, due to both stigma and lack of trained providers and resources. These challenges can lead to complications in the management of chronic disease as well as increased suffering for patients, families and communities. In this study, we evaluate the effects of integrating mental health and chronic disease treatment of patients in primary health care (PHC) settings using a collaborative care model to improve the screening, diagnosis and treatment of depression in rural India.MethodsThis study is a multi-level randomized controlled trial among patients with depression or anxiety and co-morbid diabetes, or cardiovascular disease. Aim 1 examines whether patients screened at community health-fairs are more likely to be diagnosed and treated for these co-morbid conditions than patients screened after presenting at PHCs. Aim 2 evaluates the impact of collaborative care compared to usual care in a cluster RCT, randomizing at the level of the PHCs. Intervention arm PHC staff are trained in mental health diagnoses, treatment, and the collaborative care model. The intervention also involves community-based “Healthy Living groups” co-led by Ashas, using cognitive-behavioral strategies to promote healthy behaviors. The primary outcome is severity of common mental disorders, with secondary outcomes being diabetes and cardiovascular risk, staff knowledge and patient perceptions.DiscussionIf effective, our results will contribute to the field in five ways: 1) expand on implementation research in low resource settings by examining how multiple chronic diseases can be treated using integrated low-cost, evidence-based strategies, 2) build the capacity of PHC staff to diagnose and treat mental illness within their existing clinic structure and strengthen referral linkages; 3) link community members to primary care through community-based health fairs and healthy living groups; 4) increase mental health awareness in the community and reduce mental health stigma; 5) demonstrate the potential for intervention scale-up and sustainability.Trial registrationhttp://Clinicaltrials.gov: NCT02310932 registered December 8, 2014 URL: https://clinicaltrials.gov/ct2/show/record/NCT02310932; Clinical Trials Registry India: CTRI/2018/04/013001 retrospectively registered on April 4, 2018.

Effects of integrated models of care for diabetes and hypertension in low-income and middle-income countries: a systematic review and meta-analysis

“…We classified this study as 'awaiting assessment', as we are unable to definitively decide on inclusion or exclusion until we have access to the full report. We identified five ongoing RCTs, [48][49][50][51] investigating integrated care for depression and hypertension in China; 48 integrated care for depression and hypertension 49 or depression and diabetes/ HIV 50 in South Africa; integrated care for common mental disorders and hypertension, diabetes or ischaemic heart disease in India 51 ; and diabetes and TB in India. 52…”

Perceptions of Asha Workers in the Hope Collaborative Care Mental Health Intervention in Rural South India: A Qualitative Analysis

“…Nevertheless, ASHA workers are rarely targeted by community mental health awareness campaigns [12,27]. Considering the importance of ASHA workers in rural healthcare and their increasing participation in mental health interventions [5,13,21,28], they should be included in mental health education efforts.…”

“…This study is a follow-up to the parent HOPE RCT that is implementing and evaluating the integration of mental health interventions in primary care [28]. In the HOPE study, ASHA workers performed the role of liaison between patients and primary health center (PHC) staff, which included conducting home visits and delivering reminders to HOPE patients about appointments.…”

“…Perspectives of ASHA workers in general have been greatly overlooked, and as more ASHA workers take on additional responsibilities, it is important to understand their experiences and beliefs, particularly about community-based mental health interventions. The aim of this sub-study was to use qualitative methods to investigate the perspectives and beliefs of the ASHA workers who participated in the HOPE study, a cluster randomized controlled trial (RCT) which used a collaborative care model to integrate mental health treatment in primary care clinics in a rural district of Karnataka [28].…”

Community Participatory Learning and Action Cycle Groups to Reduce Type 2 Diabetes in Bangladesh (DClare): Study Protocol for a Stepped-Wedge Cluster Randomised Controlled Trial

“…[6] Prevention and control efforts have predominantly targeted individual behaviour change amongst high-risk groups, with mixed results in South Asian settings. [7][8][9][10][11][12] There is a need to develop and test population level interventions that create an enabling environment for the prevention of T2DM at scale, shifting from individualistic to structural and social interventions. [13] The DMagic (Diabetes Mellitus Action through community Groups or mHealth Information for better Control) trial used a participatory learning and action (PLA) approach directed at the general population in rural Bangladesh.…”