JMIR Publications

ABSTRACT

Background:

Background:

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.

Objective:

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.

Results:

The study was funded on April 15, 2019. The study received ethical approval from Ethics Committee, NIMHANS on February 3, 2020. The trial got registered in Clinical Trials Registry of India (CTRI) on May 6th 2020. Approval from Health Ministry Screening Committee (HMSC) on June 12, 2020 and from the University of York, Health Sciences Research Governance Committee on November 27, 2020. Following the receipt of approval from all the respective committees, the development of BEACON intervention package was started from November 28, 2020 and was completed on August 18, 2021 and the quantitative data collection was started on August 23, 2021 and completed on December 10, 2021. Process evaluation (Qualitative data collection) is ongoing and the quantitative data analysis is expected to be completed by September 30, 2022.

Conclusions:

This study is an attempt to adapt and test the feasibility of behavioural activation intervention which is designed to be delivered by non-specialist health workers supervised by mental health experts, and integrated within NCD care to reduce the treatment gap for mental disorders in NCD. This work will support a future definitive trial evaluation of BA for depression in NCD in India. Clinical Trial: CTRI/2020/05/025048 [Registered on: 06/05/2020], http://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=41194&EncHid=94832.51996&modid=1&compid=19