Abstract
Background
The lockdown associated with the COVID-19 pandemic is likely to impact people’s mental health, especially those from economically disadvantaged and vulnerable sections of society. Mental health can be affected by many factors, including fear of disease transmission, from response measures against the pandemic like social distancing, movement restriction, fear of being in quarantine, loneliness, depression due to isolation, fear of losing work and livelihood and avoiding health care due to fear of being infected. Telephonic befriending intervention by non-specialists will be used to provide social and emotional support to the youth from the Deen Dayal Upadhyaya Grameen Kaushalya Yojana (DDUGKY), an initiative of the Government of India. This study aims to promote mental wellbeing and reduce depressive symptoms by assisting participants to mobilise social support from family, friends and significant others by using the telephonic befriending intervention.
Methods
In this article, we report the design and protocol of a multi-centre cluster randomised controlled trial. In total, 1440 participants aged 18–35 years who have recently completed their course out of the DDU-GKY initiative will be recruited in the study from 12 project-implementing agencies (PIAs) across six geographical zones of India. Participants from 6 of these agencies will be assigned to the telephonic befriending intervention arm, and the other six agency participants will be assigned to the general enquiry phone call arm (control). The primary outcomes of this study are mental wellbeing, depressive symptoms and perceived social support. Baseline assessments and follow-up assessments will be carried out 1 month following the intervention using WHO-5, PHQ and MSPSS-12 questionnaires. The befriending intervention will be provided by DDU-GKY staff, whom a virtual training programme will train.
Discussion
This trial will help assess whether participants who are offered emotional, social and practical support through befriending will experience lesser symptoms of depression and better mental health compared to participants who do not receive this intervention through mobilised social support from friends, family and others.
Trial registration
Clinical Trial Registry India (ICMR-NIMS) CTRICTRI/2020/07/026834. Registered on 27 July 2020.
Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial
