EMPOWERED trial: protocol for a randomised control trial of digitally supported, highly personalised and measurement-based care to improve functional outcomes in young people with mood disorders

Ian B Hickie; Frank Iorfino; Cathrin Rohleder; Yun Ju Christine Song; Alissa Nichles; Natalia Zmicerevska; William Capon; Adam J Guastella; F Markus Leweke; Jan Scott; Patrick D McGorry; Cathrine Mihalopoulos; Eoin Killackey; Min Chong; Sarah McKenna; Melissa Aji; Carla Gorban; Jacob J Crouse; Dagmar Koethe; Robert A Battisti; Blake A Hamilton; Alice Lo; Maree Hackett; Daniel Hermens; Mind Plasticity Consortia; Headspace Camperdown Consortia; Elizabeth M Scott

doi:10.1136/bmjopen-2023-072082

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EMPOWERED trial: protocol for a randomised control trial of digitally supported, highly personalised and measurement-based care to improve functional outcomes in young people with mood disorders

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EMPOWERED trial: protocol for a randomised control trial of digitally supported, highly personalised and measurement-based care to improve functional outcomes in young people with mood disorders

Ian B Hickie, Frank Iorfino, Cathrin Rohleder, Yun Ju Christine Song, Alissa Nichles, Natalia Zmicerevska, William Capon, Adam J Guastella, F Markus Leweke, Jan Scott, …

BMJ Open, Vol.13(10), pp.1-12

2023

DOI: https://doi.org/10.1136/bmjopen-2023-072082

PMCID: PMC10583041

PMID: 37821139

Appears in Thompson Institute Research Collection

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Abstract

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Objectives: Many adolescents and young adults with emerging mood disorders do not achieve substantial improvements in education, employment, or social function after receiving standard youth mental health care. We have developed a new model of care referred to as ‘highly personalised and measurement-based care’ (HP&MBC). HP&MBC involves repeated assessment of multidimensional domains of morbidity to enable continuous and personalised clinical decision-making. Although measurement-based care is common in medical disease management, it is not a standard practice in mental health. This clinical effectiveness trial tests whether HP&MBC, supported by continuous digital feedback, delivers better functional improvements than standard care and digital support. Method and analysis: This controlled implementation trial is a PROBE study (Prospective, Randomised, Open, Blinded End-point) that comprises a multisite 24-month, assessor-blinded, follow-up study of 1500 individuals aged 15–25 years who present for mental health treatment. Eligible participants will be individually randomised (1:1) to 12 months of HP&MBC or standardised clinical care. The primary outcome measure is social and occupational functioning 12 months after trial entry, assessed by the Social and Occupational Functioning Assessment Scale. Clinical and social outcomes for all participants will be monitored for a further 12 months after cessation of active care. Ethics and dissemination: This clinical trial has been reviewed and approved by the Human Research Ethics Committee of the Sydney Local Health District (HREC Approval Number: X22-0042 & 2022/ETH00725, Protocol ID: BMC-YMH-003-2018, protocol version: V.3, 03/08/2022). Research findings will be disseminated through peer-reviewed journals, presentations at scientific conferences, and to user and advocacy groups. Participant data will be deidentified. Trial registration number: ACTRN12622000882729.

Details

Title: EMPOWERED trial: protocol for a randomised control trial of digitally supported, highly personalised and measurement-based care to improve functional outcomes in young people with mood disorders
Authors: Ian B Hickie (Author) - The University of Sydney
Frank Iorfino (Corresponding Author) - The University of Sydney
Cathrin Rohleder (Author) - The University of Sydney
Yun Ju Christine Song (Author) - The University of Sydney
Alissa Nichles (Author) - The University of Sydney
Natalia Zmicerevska (Author) - The University of Sydney
William Capon (Author) - The University of Sydney
Adam J Guastella (Author) - The University of Sydney
F Markus Leweke (Author) - The University of Sydney
Jan Scott (Author) - Newcastle University
Patrick D McGorry (Author) - The University of Melbourne
Cathrine Mihalopoulos (Author) - Monash University
Eoin Killackey (Author) - The University of Melbourne
Min Chong (Author) - The University of Sydney
Sarah McKenna (Author) - The University of Sydney
Melissa Aji (Author) - The University of Sydney
Carla Gorban (Author) - The University of Sydney
Jacob J Crouse (Author) - The University of Sydney
Dagmar Koethe (Author) - The University of Sydney
Robert A Battisti (Author) - Mind Australia
Blake A Hamilton (Author) - The University of Sydney
Alice Lo (Author) - Mind Australia
Maree Hackett (Author) - The George Institute for Global Health
Daniel Hermens (Author) - University of the Sunshine Coast, Queensland, Thompson Institute
Mind Plasticity Consortia (Author)
Headspace Camperdown Consortia (Author)
Elizabeth M Scott (Author) - The University of Sydney
Publication details: BMJ Open, Vol.13(10), pp.1-12
Publisher: BMJ Group
Date published: 2023
DOI: 10.1136/bmjopen-2023-072082
ISSN: 2044-6055
PMID: 37821139; PMC10583041
Copyright note: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Grant note: GNT2016346 / NHMRC L3 Investigator Grant GNT2018157 / NHMRC EL1 Investigator Grant GNT2008197 / NHMRC Emerging Leadership Fellowship
Organisation Unit: University of the Sunshine Coast, Queensland; Thompson Institute
Language: English
Record Identifier: 99971192402621
Output Type: Journal article

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