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Can a digital intervention 'Momentum improve social functioning and transdiagnostic symptoms for Australian youth at ultrahigh risk for psychosis? Protocol for a superiority randomised controlled trial comparing treatment as usual with and without Momentu

Por: Mangelsdorf · S. N. · Cagliarini · D. · Nelson · B. · McEnery · C. · Whiting · J. · Chinnery · G. · Valentine · L. · Lee · Y. Y. · Mihalopoulos · C. · Liu · V. · Bendall · S. · Koval · P. · DAlfonso · S. · Gonzalez-Blanch · C. · Ryan · R. M. · Lederman · R. · H Lim · M. · McGorry · P. · Po
Introduction

Existing psychological and pharmacological interventions for young people at ultra-high risk (UHR) for psychosis have shown benefit in at least delaying the transition to psychosis, but they have limited benefit for comorbid disorders or social dysfunction, which are prominent for those at UHR. We developed a moderated online social therapy platform (named Momentum) including: (1) transdiagnostic therapeutic interventions targeting social functioning, depression, generalised anxiety and social anxiety; (2) a moderated, peer-led online community and (3) specialised human support from clinicians, career consultants and peer workers. The aim of this trial is to determine whether, in addition to treatment as usual (TAU), Momentum, a 12-month digital intervention, informed by the complex intervention framework, is superior to 12 months of TAU in improving social functioning in UHR young people.

Methods and analysis

The study design is a prospective, parallel group, rater-masked randomised controlled trial. We will recruit young people aged 14–27 years, meeting one or more UHR for psychosis criteria. Participants are randomly assigned to the condition using randomly permutated blocks with a 1:1 allocation ratio. Participants are stratified by age (

Ethics and dissemination

Melbourne Health Human Research Ethics Committee (HREC/42964/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. De-identified individual participant data will be available after publication for 3 years via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. Supplementary material including study protocol, informed consent material and statistical analysis plan will also be available.

Trial registration number

Australian New Zealand Clinical Trial Registry (ANZCTR), ACTRN12619001411134.

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