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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BMJ Publishing Group
2024-11-01
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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. |
| format | Article |
| id | doaj-art-b495b321c7ac45f4938baabf8f48d5ce |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| 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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