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

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][1]) adapt BA for the Indian NCD context, ([2][2]) test the acceptability, feasibility and implementation of the adapted BA intervention (BEACON intervention package, BIP), and ([3][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], 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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial CTRI/2020/05/025048 ### Funding Statement This study 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. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: 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 gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: #ref-1 [2]: #ref-2 [3]: #ref-3