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Trial registered on ANZCTR

Registration number

ACTRN12622000882729

Ethics application status

Approved

Date submitted

24/05/2022

Date registered

22/06/2022

Date last updated

29/09/2024

Date data sharing statement initially provided

22/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Highly Personalised and Measurement-Based Care implementation trial for mental health treatment seeking young people.

Scientific title

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.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

EMPOWERED Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mood disorders

Anxiety disorders

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The Standardised Care Package: builds on the usual service systems (largely Medicare-funded psychological care), including systematic assessment and allocation of clinical care within multidisciplinary team environments. In this trial, however, an improved offering is provided through (a) greater standardisation of assessment, (b) repeated e-health assessment and feedback of those assessments, (c) provision of standard multidisciplinary care options.

The e-health assessments will be completed via the digital platform. The participants will complete this independently and will be prompted via a link that will be send to their email to complete the assessment. The initial assessment will take approximately 30-40 minutes and the follow-up assessments (at least monthly) will take approximately 10-15 mins for the participant to complete.
Note there will not be the same level of coordinated care in the comparator group. They will not have access to a clinical facilitator or functional facilitator. Adherance however will be monitored by the digital navigator.

Follow-up research assessments will be conducted at 3, 6, 12 & 24mths after the commencement of treatment.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measures is social and occupational function (SaOF) and will be assessed by the continuous Social and Occupational Functioning Assessment Scale (SOFAS)

Timepoint [1]

12 months post-intervention commencement is the primary timepoint.
In addition to the 12mth post intervention commencement timepoint, this measure will also be assessed at 3, 6, and 24mths post intervention commencement.

Secondary outcome [1]

Changes from baseline in suicidal thoughts and behaviours. Measures used:
- Suicidal Ideation Attribution Scale (SIDAS)
- Columbia-Suicide Severity rating Scale (C-SSRS)

Suicidal thoughts and behaviours will be analysed together as a composite outcome.

Timepoint [1]

This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.

Secondary outcome [2]

Change from baseline in depressive symptoms. Measure used will be the Quick Inventory Depressive Symptomatology, Adolescent version, 17-item clinician completed. (QIDS-A-17-C)

Timepoint [2]

This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.

Secondary outcome [3]

Change from baseline in quality of life. Measure used: Assessment of Quality of life Four Dimension (AQoL-4D).

Timepoint [3]

This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.

Secondary outcome [4]

Change from baseline in alcohol and substance use. Measures used:
- World Health Organisation (WHO) Alcohol, Smoking and Substance Screening Test (WHO-ASSIST)
- Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).
These changes will be assessed as a composite secondary outcome.

Timepoint [4]

This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.

Secondary outcome [5]

Change from baseline in physical health. Measurement:
- metabolic markers via blood test including blood sugar, triglycerides, high-density lipoprotein.

Timepoint [5]

This measure will be assessed at 6, 12 and 24 months post-intervention commencement.

Secondary outcome [6]

Resource use as well as lifetime and population cost-effectiveness.
This will be a composite outcome.
Measured using two main procedures: 1. Participants will be asked for access to their Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Schedule (PBS) data for the duration of the study. 2. A resource use questionnaire developed by the associate investiga-tor Professor Cathrine Mihalopoulos and modified for use in multiple mental health eco-nomic evaluations. The Resource Use Questionnaire will capture the broad range of health and welfare services used not captured in Medicare or the other administrative datasets. Standardised economic evaluation techniques including incremental analysis of mean dif-ferences using generalised linear models, and bootstrapping to determine confidence inter-vals will be used. Lifetime and population cost-effectiveness will be also determined using economic modelling techniques.

Timepoint [6]

This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.

Secondary outcome [7]

Costs of the treatment packages based on detailed economic evaluation.
The economic evaluation of the HP&MBC package is critical to translate this research into practice. It will comprise both a “within-trial” design whereby the individual level costs, and outcomes of the two groups (HP&MBC and Standard Care packages), will be included in the evaluation over the duration of the trial. A modelled evaluation will be undertaken to capture full costs and consequences of HP&MBC, using the results of this trial and the broader epidemiological literature to estimate likely longer term health gains, cost impacts and scale up costs at the population level. The calculation of quality-adjusted life years (QALYs) will be done, thus enabling a cost-utility analysis to be undertaken. Cost-utility analyses are useful to decision-makers as they are associated with inherent value for money connota-tions. Detailed costing of the HP&MBC approach along with how it has been implemented within each site will be undertaken using information from the researchers, clinical staff, and budgetary personnel.

Timepoint [7]

This measure will be assessed at 12 months post-intervention commencement.

Secondary outcome [8]

Changes from baseline in self-harm. Measures used:
- Brief Non-suicidal self-injury Assessment Tool (B-NSSI-AT)

Timepoint [8]

This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.

Secondary outcome [9]

Change from baseline in Body Mass Index (BMI). Height and weight will be self-reported measures.

Timepoint [9]

This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.

Secondary outcome [10]

Change from baseline in physical health. Measurement:
Inflammatory markers via blood test. (CPR and ESR) and will be looked as a composite measure

Timepoint [10]

This measure will be assessed at 6, 12 and 24 months post-intervention commencement.

Eligibility

Key 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.

Minimum age

15 Years

Maximum age

25 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation conducted off-site via The George Institute.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This trial seeks to recruit 1,500 young people, with 750 allocated to active 12-month intervention and 750 to standard clinical care. We anticipate an attrition rate of approximately 10-20% over short-term follow up (first 12 months) and up to 30% over the longer-term follow-up (at 24 months). Therefore, we would expect 1350 participants at six months follow-up (675 in each arm), 1200 participants at 12 months follow-up (600 in each arm) and 1050 participants at two years follow-up (525 in each arm). Assuming that we have at least 434 young people at the two-year follow-up time point, for the primary outcome analysis only, and conservatively assuming a small effect size difference of 0.2 in favour of those young people receiving the active intervention, a=0.05, we have 95% power. For categorical secondary analyses, a small effect size of 0.2, a=0.05, power=95%, sample size at two-year follow-up is 325 participants. There are also embedded sub-groups for secondary analyses (e.g., by baseline suicidal acts, depressive sub-type, alcohol or other substance misuse and baseline SOFAS bands). For these subgroups, assuming that we have at least 195 young people at the two-year follow-up time point, for the primary outcome analysis only, and conservatively assuming a medium effect size difference of 0.3 in favour of those young people receiving the active intervention, a=0.05, we have 95% power. For categorical secondary analyses, a medium effect size of 0.3, a=0.05, power=95%, sample size at two-year follow-up is 144 participants.

Data analysis plan
The primary outcome will be analysed using a repeated-measure linear mixed model including all available SOFAS scores measured at months 3, 6, 12 and 24. Fixed effects will include the randomised group, visit as a categorical variable and the interaction between group and visit. The baseline SOFAS score will be included as a covariate alongside sex, age and site (stratification variables). To account for correlations between repeated measures, a random patient intercept will be included. In case of convergence issues with the inclusion of the random effect, we will replace the random effect with a repeated effect assuming a compound symmetry covariance structure. This model will be used to derive the effect of the intervention at 12 months, expressed as the adjusted mean difference and its 95% confidence interval. The effect of the intervention at other timepoints will be estimated using a similar approach. Secondary outcomes will be analysed using a similar approach. For binary outcomes, logistic regression (binomial distribution with logit link) will be used in place of linear regression. The effect of the intervention will be estimated as the odds ratio and 95% confidence interval and converted to an absolute risk difference using the Hummel and Wiseman method. Given that linear mixed models use all data available and make valid inference under the assumption that data is missing at random, the primary analysis will not impute missing data; however, sensitivity analyses will be conducted to assess the robustness of the results under different assumptions about the missing data mechanism. A detailed statistical analysis plan including mock tables will be developed prior to unblinding and database lock.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/01/2023

Actual

1/03/2023

Date of last participant enrolment

Anticipated

1/08/2025

Actual

Date of last data collection

Anticipated

1/08/2027

Actual

Sample size

Target

1500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2010 - Surry Hills

Recruitment postcode(s) [2]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney,
Darlington
NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Ethics and Governance Office
Royal Prince Alfred Hospital, 
50 Missenden Rd, Camperdown, 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/04/2022

Approval date [1]

12/05/2022

Ethics approval number [1]

X22-0042 & 2022/ETH0072

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ian B. Hickie

Address

Co-Director and Consultant Psychiatrist, Brain and Mind Centre, The University of Sydney
Address: Building F, Level 4, Brain and Mind Centre, The University of Sydney, 94 Mallett St, Camperdown, NSW 2050 AUSTRALIA

Country

Australia

Phone

+61 2 9351 0810

Fax

[email protected]

Contact person for public queries

Name

Ian B. Hickie

Address

Country

Australia

Phone

+61 2 9351 0810

Fax

[email protected]

Contact person for scientific queries

Name

Ian B. Hickie

Address

Country

Australia

Phone

+61 2 9351 0810

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We are not planning to deposit the data with an archive or repository or publish them on the web. For the purposes of the study specific research question, the sharing of individual participant information is not going to be meaningful. However, the aggregate de-identified participant data will be used for publications in high quality, peer-reviewed scientific journals and/or scientific conferences.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16181	Ethical approval					384073-(Uploaded-24-05-2022-11-19-06)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2023	https://dx.doi.org/10.1136/bmjopen-2023-072082

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

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