Behavioural activation for co- morbid depression in people with non-communicable disease in India: Protocol for a randomised controlled feasibility trial (BEACON)

ABSTRACT Introduction The increasing burden of depression and non-communicable disease (NCD) is a global challenge, especially in low- and middle-income countries (LMIC) considering the resource constraints and lack of manpower in these settings. Brief psychological therapies such as behavioural activation (BA), have shown to be effective for the treatment of depression. However, their feasibility and effectiveness for depression in people with NCDs in Indian community setting has not been systematically evaluated. Hence, in this study, we conceptualize to adapt BA into Indian NCD context, thus to improve the management of depression in people with NCD in India. Aims To (1) adapt BA for the Indian NCD context, (2) test the acceptability, feasibility and implementation of the adapted BA intervention (BEACON intervention package, BIP), and (3) test the feasibility of a randomised controlled trial evaluation of BIP for the treatment of depression compared with enhanced usual care. Methods Following well-established frameworks for intervention adaptation, we first adapted BA (to fit the linguistic, cultural and resource context) for delivery in India. The intervention was also adapted for potential remote delivery via telephone. In a randomised controlled trial, we will then test acceptability, feasibility and implementation of the adapted BA intervention (BEACON Intervention package, BIP). We also test if a randomised controlled feasibility trial can be delivered effectively and estimate important parameters (e.g. recruitment and retention rates and completeness of follow up) needed to design a future definitive trial. Findings: will be used to refine procedures for a future definitive trial evaluation of the effectiveness (and cost-effectiveness) of the BIP compared with enhanced usual care for the treatment of depression in NCDs. Ethics and dissemination The study has received ethics approval by the University of York Health Sciences Research Governance Committee, UK; the Health Ministry Screening Committee, India; and the Ethics Committee (Behavioural Sciences Division), NIMHANS, Bangalore, India. Trial Registration CTRI/2020/05/025048 [Registered on: 06/05/2020], http://ctri.nic.in This research was funded by the National Institute for Health Research (NIHR) (17/63/130) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK government.