TY - JOUR
T1 - A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia
T2 - study protocol for a randomised controlled trial of Rebound
AU - Mangelsdorf, Shaminka N.
AU - Cagliarini, Daniela
AU - Lee, Yong Yi
AU - Mihalopoulos, Cathrine
AU - Liu, Virginia
AU - Valentine, Lee
AU - Bendall, Sarah
AU - Koval, Peter
AU - D'alfonso, Simon
AU - Davey, Christopher
AU - Russon, Penni
AU - Phillips, Jess
AU - Gonzalez-Blanch, Cesar
AU - Pawsey, Brendan
AU - Ryan, Richard M.
AU - Parker, Alexandra
AU - Hetrick, Sarah
AU - Rice, Simon
AU - Lederman, Reeva
AU - Herrman, Helen
AU - Murray, Greg
AU - Gleeson, John
AU - Alvarez-Jimenez, Mario
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.
PY - 2024/11/27
Y1 - 2024/11/27
N2 - 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.
AB - 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.
KW - Depression & mood disorders
KW - Psychosocial Intervention
KW - Randomized Controlled Trial
UR - http://www.scopus.com/inward/record.url?scp=85211198867&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2024-088695
DO - 10.1136/bmjopen-2024-088695
M3 - Article
C2 - 39609033
AN - SCOPUS:85211198867
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e088695
ER -