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 treatmen...

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Main Authors: 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
Format: Article
Language:English
Published: BMJ Publishing Group 2024-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/11/e088695.full
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author 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
author_facet 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
author_sort Mario Alvarez-Jimenez
collection DOAJ
description 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.
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spelling doaj-art-b495b321c7ac45f4938baabf8f48d5ce2025-08-20T02:38:23ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2024-088695A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of ReboundMario Alvarez-Jimenez0Sarah Bendall1Peter Koval2Simon Rice3Daniela Cagliarini4Lee Valentine5Penni Russon6Jess Phillips7Reeva Lederman8Cathrine Mihalopoulos9Helen Herrman10Cesar Gonzalez-Blanch11Alexandra Parker12Shaminka N Mangelsdorf13Richard M Ryan14Sarah Hetrick15Yong Yi Lee16Greg Murray17Christopher Davey18Virginia Liu19Simon D'Alfonso20Brendan Pawsey21John Gleeson222 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia6 Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia1 Orygen, Parkville, Victoria, Australia2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia1 Orygen, Parkville, Victoria, Australia10 School of Languages, Literatures, Cultures and Linguistics, Monash University, Melbourne, Victoria, Australia11 School of Psychological Sciences, Monash University, Melbourne, Victoria, Australia8 School of Computing and Information Systems, The University of Melbourne, Parkville, Victoria, Australia3 Monash University Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia2 Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia1 Orygen, Parkville, Victoria, Australia1 Orygen, Parkville, Victoria, Australia14 Institute for Positive Psychology and Education, Australian Catholic University, North Sydney, New South Wales, Australia17 Department of Psychological Medicine, The University of Auckland, Auckland, New Zealand3 Monash University Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia19 Centre for Mental Health and Brain Sciences, Swinburne University of Technology, Hawthorn, Victoria, Australia9 Department of Psychiatry, The University of Melbourne, Parkville, Victoria, Australia1 Orygen, Parkville, Victoria, Australia8 School of Computing and Information Systems, The University of Melbourne, Parkville, Victoria, Australia13 Mercy Health, Melbourne, Victoria, Australia20 Healthy Brain and Mind Research Centre, School of Behavioural and Health Sciences, Australian Catholic University, Fitzroy, Victoria, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/14/11/e088695.full
spellingShingle 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
A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound
BMJ Open
title A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound
title_full A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound
title_fullStr A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound
title_full_unstemmed A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound
title_short A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound
title_sort mindfulness based cognitive social digital relapse prevention intervention for youth with depression in australia study protocol for a randomised controlled trial of rebound
url https://bmjopen.bmj.com/content/14/11/e088695.full
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