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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
11/10/2023
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] 307141 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMPOWERED Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood disorders 326366 0
Anxiety disorders 326367 0
Condition category
Condition code
Mental Health 323665 323665 0 0
Depression
Mental Health 323666 323666 0 0
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] 323615 0
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] 331411 0
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] 331411 0
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] 409763 0
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] 409763 0
This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.
Secondary outcome [2] 409773 0
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] 409773 0
This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.
Secondary outcome [3] 409774 0
Change from baseline in quality of life. Measure used: Assessment of Quality of life Four Dimension (AQoL-4D).
Timepoint [3] 409774 0
This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.
Secondary outcome [4] 409775 0
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] 409775 0
This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.
Secondary outcome [5] 409776 0
Change from baseline in physical health. Measurement:
- metabolic markers via blood test including blood sugar, triglycerides, high-density lipoprotein.
Timepoint [5] 409776 0
This measure will be assessed at 6, 12 and 24 months post-intervention commencement.
Secondary outcome [6] 409777 0
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] 409777 0
This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.
Secondary outcome [7] 409779 0
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] 409779 0
This measure will be assessed at 12 months post-intervention commencement.
Secondary outcome [8] 410604 0
Changes from baseline in self-harm. Measures used:
- Brief Non-suicidal self-injury Assessment Tool (B-NSSI-AT)
Timepoint [8] 410604 0
This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.
Secondary outcome [9] 410605 0
Change from baseline in Body Mass Index (BMI). Height and weight will be self-reported measures.
Timepoint [9] 410605 0
This measure will be assessed at 3, 6, 12 and 24 months post-intervention commencement.
Secondary outcome [10] 410606 0
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] 410606 0
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?
No
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
62
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37624 0
2010 - Surry Hills
Recruitment postcode(s) [2] 37625 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311447 0
Government body
Name [1] 311447 0
National Health and Medical Research Council
Country [1] 311447 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
Darlington
NSW 2006
Country
Australia
Secondary sponsor category [1] 312919 0
None
Name [1] 312919 0
Address [1] 312919 0
Country [1] 312919 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310920 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310920 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital,
50 Missenden Rd, Camperdown, 2050
Ethics committee country [1] 310920 0
Australia
Date submitted for ethics approval [1] 310920 0
20/04/2022
Approval date [1] 310920 0
12/05/2022
Ethics approval number [1] 310920 0
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 119350 0
Prof Ian B. Hickie
Address 119350 0
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 119350 0
Australia
Phone 119350 0
+61 2 9351 0810
Fax 119350 0
Email 119350 0
ian.hickie@sydney.edu.au
Contact person for public queries
Name 119351 0
Prof Ian B. Hickie
Address 119351 0
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 119351 0
Australia
Phone 119351 0
+61 2 9351 0810
Fax 119351 0
Email 119351 0
ian.hickie@sydney.edu.au
Contact person for scientific queries
Name 119352 0
Prof Ian B. Hickie
Address 119352 0
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 119352 0
Australia
Phone 119352 0
+61 2 9351 0810
Fax 119352 0
Email 119352 0
ian.hickie@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
16181Ethical 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
SourceTitleYear of PublicationDOI
EmbaseEMPOWERED 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.2023https://dx.doi.org/10.1136/bmjopen-2023-072082
N.B. These documents automatically identified may not have been verified by the study sponsor.