A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound.

INTRODUCTION

Major depressive disorder (MDD) causes significant disease burden and functional impairment during adolescence and young adulthood. While most young people recover from their first episode, around two-thirds will experience one or more relapses, which can become more severe and treatment-resistant with each episode. To address relapse in MDD, we developed a moderated online social therapy platform (titled ) that integrates: (i) peer-to-peer social networking; (ii) tailored third-wave therapeutic content targeting mindfulness, self-compassion and rumination; and (iii) three types of human support (clinicians, peer workers, career consultants), informed by self-determination theory. The aim of this trial is to determine whether, in addition to treatment as usual (TAU), , an 18-month complex digital intervention, is superior to 18 months of enhanced TAU in preventing relapse and managing depressive symptoms.

METHODS AND ANALYSIS

This study is a rater-masked randomised controlled trial. The treatment conditions include plus TAU or enhanced TAU alone. We aim to recruit 255 young people with at least one episode of MDD, aged 14-27 years. The study includes monthly assessment points over 18 months. The study includes a 48-month recruitment period and an 18-month treatment phase. The primary outcome is depressive relapse at 18 months, as measured by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Research Version (SCID-5-RV). Secondary outcomes include the severity of depressive symptoms, time to relapse, time to remission, remission status, severity of anxiety symptoms, study and employment outcomes and cost-effectiveness. We will also examine four therapeutic mechanisms (mindfulness, self-compassion skills, social support and reduced rumination) to understand the 'how and why' of the intervention effects.

ETHICS AND DISSEMINATION

Melbourne Health Human Research Ethics Committee (HREC/42967/MH-2018) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website.

TRIAL REGISTRATION NUMBER

ANZCTR, ACTRN12619001412123.