A pilot randomised controlled trial of a guided online problem-solving intervention delivered through smartphones for secondary school pupils during the COVID-19 pandemic in India: Study protocol.

Gonsalves, Pattie P; Sharma, Rhea; Hodgson, Eleanor Sara; Bhat, Bhargav; Jambhale, Abhijeet; Weiss, Helen A; Fairburn, Christopher G; Cavanagh, Kate; Cuijpers, Pim; Michelson, Daniel; Patel, Vikram

BACKGROUND 'POD Adventures' is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomised controlled trial of a remotely-delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE The objectives are to assess the feasibility of research procedures and intervention delivery and generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS We will conduct a parallel, two-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post-randomisation. RESULTS The first participant was enrolled on January 28, 2021 and 6-week assessment completed on April 4, 2021. Due to a second wave of COVID-19 in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS This pilot trial will help with understanding the feasibility of implementing and evaluating a remotely-delivered, digital mental health intervention in a low-resource setting. The findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. CLINICALTRIAL This pilot trial is registered with the National Institute of Health registry (www. clinicaltrials.gov), registration number NCT04672486, registered on December 17, 2020. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30339.