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
,
Daniel F Hermens,
Adam J Guastella,
Jan Scott,
Elizabeth M Scott,
Ian B Hickie,
Eoin Killackey,
Cathrine Mihalopoulos,
Maree L Hackett,
Frank Iorfino,
Alice Lo,
Patrick McGorry,
Alissa Nichles,
Natalia Zmicerevska,
Jacob J Crouse,
Cathrin Rohleder,
Yun Ju Christine Song,
Blake Hamilton,
Dagmar Koethe,
F Markus Leweke,
Sarah McKenna,
William Capon,
Min K Chong,
Melissa Aji,
Carla Gorban,
Robert Battisti,
Mark Yim,
Bradley Whitwell,
Alison Crowley,
Donna Fowler,
Elana Volanakis,
Vicki Papageorgopoulos,
Matilda Russel,
Elizabeth Phung
Affiliations
Daniel F Hermens
Thompson Institute, University of the Sunshine Coast, Birtinya, Queensland, Australia
Adam J Guastella
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Jan Scott
Newcastle University, Newcastle upon Tyne, UK
Elizabeth M Scott
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Ian B Hickie
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Eoin Killackey
Centre for Youth Mental Health, University of Melbourne Australia, Parkville, Victoria, Australia
Cathrine Mihalopoulos
3 Monash University Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia
Maree L Hackett
George Institute for Global Health, Newtown, New South Wales, Australia
Frank Iorfino
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Alice Lo
Mind Plasticity, Sydney, New South Wales, Australia
Patrick McGorry
The University of Melbourne, Melbourne, Victoria, Australia
Alissa Nichles
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Natalia Zmicerevska
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Jacob J Crouse
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Cathrin Rohleder
1 Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Yun Ju Christine Song
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Blake Hamilton
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Dagmar Koethe
1 Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
F Markus Leweke
1 Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Sarah McKenna
Administrative Data Research Centre Northern Ireland, Queen`s University Belfast, Belfast, UK
William Capon
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Min K Chong
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Melissa Aji
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Carla Gorban
Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia
Robert Battisti
College of Medicine, Department of Internal Medicine, Central Michigan University, Saginaw, Michigan, USA
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.
