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Highly Personalised and Measurement-Based Care implementation trial for mental health treatment seeking young people (EMPOWERED Trial)

A large-scale clinical effectiveness (health services) trial to determine whether personalised health care packages, combined with digitally-supported measurement-based care, changes functional outcomes in young people with mood disorders.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000882729
Acronym
EMPOWERED Trial
Enrollment
117
Registered
2022-06-22
Start date
2023-03-01
Completion date
2026-07-01
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess in 1500 mental health treatment seeking young people whether more personalised health care packages, linked with continuous digital feedback, deliver better functional improvements at 12 months (and follow-up for a further 12 months after cessation of active care) than digitally-supported assessment linked to standard care packages. We hypothesise that the highly personalised & measurement based care (HP&MBC) treatment packages are superior to standard care packages, by implementing continuous monitoring and care coordination through the use of digital technologies, and providing extensive feedback to the clinical service, the treating clinician and the young person and their family or carer. The continuous feedback will detect unmet care, increase the likelihood of identifying persons that do not respond to treatment and facilitate the process to optimise care and increase the engagement of young people in their own care.

Interventions

1. The Highly Personalised & Measurement Based Care Package (HP&MBC): intensive, highly personalised, and assertive treatment packages, using three key streams: (a) the usual processes provided by the services at each centre, including systematic assessment and allocation of clinical care within multidisciplinary team environments (b) the therapeutic power of active and continuous feedback, through the use of a digital platform, with regards to illness type, course, response to interventions and

1. The Highly Personalised & Measurement Based Care Package (HP&MBC): intensive, highly personalised, and assertive treatment packages, using three key streams: (a) the usual processes provided by the services at each centre, including systematic assessment and allocation of clinical care within multidisciplinary team environments (b) the therapeutic power of active and continuous feedback, through the use of a digital platform, with regards to illness type, course, response to interventions and social and economic impact of care, and (c) the capacity of new assessment and monitoring techniques to tailor, plan, and track the relationships between the delivery of clinical care and social recovery strategies. The active and continuous feedback will guide evidence-based decision making related to treatment plans as it supports the choice of optimal combinations of interventions. The measurement-based feedback will help detect unmet care needs, increase the likelihood that clinicians identify young persons who are non-responsive to treatment and facilitate the process to adjust the plan of care to improve young person outcomes. The digital platform will be utilised by both the treating clinician and the participants. Participants will fill out an initial e-health assessment via the digital platform covering domains of symptoms, social and occupational functioning, self harm & suicidal thoughts and behaviours, physical health and concurrent alcohol and other substance misuse. this initial assessment will take approximately 30-40 minutes for the participant to complete. Participants will continue to update the digital platform at least monthly throughout their treatment. The follow-up data entered by participants will take approximately 10-15 minutes. Clinicians will also input data into the platform after each appointment (approx 5-10mins) to reflect the participants treatment and progress. New assessments and monitoring techniques will include assessments such as neuropsychological assessments where indicated, monitoring sleep wake cycles via the use of actigraphy devices. These assessments will be initiated by the clinician using a collaborative approach with the participant so participants are aware of the possible benefits etc of these additional assessments and monitoring techniques to better inform their treatment. Measurement based feedback based on the digital platform results will be provided by the treating clinicians as part of the participants ongoing care. The feedback will be used in a collaborative way with the participant to identify needs and help guide treatment moving forward. The anticipated frequency of feedback will be monthly over a 12 month period. Adherence to the intervention will be monitored by a research staff member who will specifically be employed as a 'digital navigator'. The digital navigator will meet with participants to explain the logistics of the digital platform and will act as a digital support person as the participant progress's through the study. There will be a team of people involved in the co-ordination of care for participants in the interventional group. This team will include the following: - Treating clinician/s - Digital facilitator to facilitate the use of the digital platform - Clinical facilitator to assist treating clinicians in tasks such as facilitating referrals and ensuring clinicians are utilising information obtained in the digital platform. - Functional facilitator to assist participants in terms of social and occuparyional functionning e.g. liasing with schools and employment services on behalf of the treating clinicians.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: • Aged 15-25 years old, seeking help for psychological distress • Classified as being Stage 1a or 1b or 2 AND • Impaired social and occupational functioning (SOFAS less than or equal to 70) • Written informed consent.

Exclusion criteria

Exclusion criteria: • Lifetime diagnosis of a full threshold psychotic or bipolar I disorder or substance dependence • Acute suicidal or aggressive behaviour requiring alternative care • Depressive syndrome secondary to a primary medical condition • IQ<70 as per medical history review

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026