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 randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions.
Objective: Our objectives are to assess the feasibility of research procedures and intervention delivery and to 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, 2-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 randomization.
Results: The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic 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 understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our 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.
Trial registration: ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486.
International registered report identifier (irrid): DERR1-10.2196/30339.
Keywords: COVID-19; India; adolescent; app; effective; feasibility; internet-based intervention; intervention; mental health; problem-solving; protocol; randomized controlled trial; schools; smartphone; teenager; young adult.
©Pattie P Gonsalves, Rhea Sharma, Eleanor Hodgson, Bhargav Bhat, Abhijeet Jambhale, Helen A Weiss, Christopher G Fairburn, Kate Cavanagh, Pim Cuijpers, Daniel Michelson, Vikram Patel. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.10.2021.