A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound
Mario Alvarez-Jimenez,
Sarah Bendall,
Peter Koval,
Simon Rice,
Daniela Cagliarini,
Lee Valentine,
Penni Russon,
Jess Phillips,
Reeva Lederman,
Cathrine Mihalopoulos,
Helen Herrman,
Cesar Gonzalez-Blanch,
Alexandra Parker,
Shaminka N Mangelsdorf,
Richard M Ryan,
Sarah Hetrick,
Yong Yi Lee,
Greg Murray,
Christopher Davey,
Virginia Liu,
Simon D'Alfonso,
Brendan Pawsey,
John Gleeson
Affiliations
Mario Alvarez-Jimenez
2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia
Sarah Bendall
2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia
Peter Koval
6 Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia
Simon Rice
1 Orygen, Parkville, Victoria, Australia
Daniela Cagliarini
2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia
Lee Valentine
1 Orygen, Parkville, Victoria, Australia
Penni Russon
10 School of Languages, Literatures, Cultures and Linguistics, Monash University, Melbourne, Victoria, Australia
Jess Phillips
11 School of Psychological Sciences, Monash University, Melbourne, Victoria, Australia
Reeva Lederman
8 School of Computing and Information Systems, The University of Melbourne, Parkville, Victoria, Australia
Cathrine Mihalopoulos
3 Monash University Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Helen Herrman
2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia
Cesar Gonzalez-Blanch
2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia
Alexandra Parker
1 Orygen, Parkville, Victoria, Australia
Shaminka N Mangelsdorf
1 Orygen, Parkville, Victoria, Australia
Richard M Ryan
14 Institute for Positive Psychology and Education, Australian Catholic University, North Sydney, New South Wales, Australia
Sarah Hetrick
17 Department of Psychological Medicine, The University of Auckland, Auckland, New Zealand
Yong Yi Lee
3 Monash University Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Greg Murray
19 Centre for Mental Health and Brain Sciences, Swinburne University of Technology, Hawthorn, Victoria, Australia
Christopher Davey
9 Department of Psychiatry, The University of Melbourne, Parkville, Victoria, Australia
Virginia Liu
1 Orygen, Parkville, Victoria, Australia
Simon D'Alfonso
8 School of Computing and Information Systems, The University of Melbourne, Parkville, Victoria, Australia
Brendan Pawsey
13 Mercy Health, Melbourne, Victoria, Australia
John Gleeson
20 Healthy Brain and Mind Research Centre, School of Behavioural and Health Sciences, Australian Catholic University, Fitzroy, Victoria, Australia
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 Rebound) 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), Rebound, 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 Rebound 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.
