Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000195550
Ethics application status
Approved
Date submitted
27/11/2023
Date registered
29/02/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
29/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A hybrid randomised controlled feasibility pilot trial of a self-management intervention “My Personal REcovery Plan” (MyPREP) for people with long term mental health conditions: The MyPREP Trial
Scientific title
A hybrid randomised controlled feasibility pilot trial of a self-management intervention “My Personal REcovery Plan” (MyPREP) for people with long term mental health conditions: The MyPREP Trial
Secondary ID [1] 311037 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 332154 0
Schizophrenia-related Disorders 332460 0
Bipolar Disorder 332461 0
Major Depressive Disorder 332462 0
Post-Traumatic Stress Disorder 332463 0
Complex Post-Traumatic Stress Disorder 332464 0
Personality Disorder 332465 0
Condition category
Condition code
Mental Health 328874 328874 0 0
Other mental health disorders
Mental Health 329157 329157 0 0
Depression
Mental Health 329158 329158 0 0
Psychosis and personality disorders
Mental Health 329159 329159 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over a 3-month period, trained staff called ‘Self-Care Champions’ from One Door Mental Health will support individuals with serious mental health conditions who are accessing their service to work through the MyPREP structured self-management tool.

MyPREP consists of different self-management modules each including psychoeducation and activities, which the participant can choose to complete:
• Recovery
• Psychoeducation
• Relapse prevention
• Crisis planning
• Wellness planning
• Goal setting

The MyPREP intervention is intended to be flexibly delivered based on the participant’s personal preference in terms of:
(1) what components of the intervention are completed based on relevance;
(2) the medium in which the intervention is delivered (paper-based; digital; discussion);
(3) how the intervention is facilitated (face-to-face; phone; digital conferencing platforms or a combination);
(4) the frequency and timing of the support sessions, with sessions being scheduled at a mutually agreed upon time and be held approximately weekly.

If MyPREP is delivered on paper, participants will receive a study-specific workbook. If MyPREP is delivered digitally, participants will be supported to register an account on the MyPREP digital platform. If MYPrep is delivered verbally, this will be facilitated by the Self-Care Champion.

The intervention is expected to take approximately 12 hours over the three month period, however, this will vary based on the participant's preference and flexible delivery of the intervention.

The Self-Care Champions facilitating the delivery of the intervention will be responsible for monitoring progress.
Intervention code [1] 327482 0
Prevention
Intervention code [2] 327701 0
Behaviour
Comparator / control treatment
For participants allocated to the control condition, they will receive usual care from the staff at One Door Mental Health. As part of usual care, Service Users get access to a Peer Support Worker but do not complete a structured self-management intervention.
Peer Support Workers engage with Service Users and their healthcare practitioners to deliver flexible supports including the development of collaborative care plans and recovery goals. They provide assistance to Service Users to develop skills for self-care and are a point of connection between the Service User, their clinicians and the community.
Control group
Active

Outcomes
Primary outcome [1] 336680 0
Feasibility of the MyPREP program
Timepoint [1] 336680 0
Post-Intervention (3 months post-baseline)
Primary outcome [2] 336681 0
Mental health quality of life
Timepoint [2] 336681 0
Baseline and post-intervention (3 months post-baseline)
Secondary outcome [1] 429312 0
Acceptability
Timepoint [1] 429312 0
Post-intervention (3 months post-baseline)
Secondary outcome [2] 429313 0
Appropriateness
Timepoint [2] 429313 0
Post-Intervention (3 months post-baseline)
Secondary outcome [3] 429315 0
Retention
Timepoint [3] 429315 0
Baseline, Post-Intervention (3 months post-baseline), Follow Up (9 months post-baseline)
Secondary outcome [4] 429316 0
Adoption
Timepoint [4] 429316 0
Baseline, Post-Intervention (3 months post-baseline)
Secondary outcome [5] 429317 0
Recovery
Timepoint [5] 429317 0
Baseline, Post-Intervention (3 months post-baseline), Follow Up (9 months post-baseline)
Secondary outcome [6] 429318 0
Changes in self-management skills
Timepoint [6] 429318 0
Baseline, Post-Intervention (3 months post-baseline), Follow Up (9 months post-baseline)
Secondary outcome [7] 429319 0
Symptoms of mental illness
Timepoint [7] 429319 0
Baseline, post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [8] 429320 0
Quality of life
Timepoint [8] 429320 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [9] 429321 0
Service Use
Timepoint [9] 429321 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [10] 429322 0
Satisfaction
Timepoint [10] 429322 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)

Eligibility
Key inclusion criteria
1. Adults aged 18 years of age and older
2. On the caseload of One Door Mental Health
3. Self-Identify as having a long-term mental health condition (such as schizophrenia related disorders, bipolar disorders, major unipolar depression; complex post traumatic stress disorder; personality disorder)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People who lack capacity to consent to take part in the study
2. People who in the view of the mental health team present such a high risk of harm to others, or it would be unsafe for researchers or a support worker to meet with them even in a mental health service setting
3. People who cannot understand the intervention when delivered in English

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
16/08/2024
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315297 0
University
Name [1] 315297 0
The University of Sydney (The Moyira Elizabeth Vine Grant for Research)
Country [1] 315297 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 317344 0
None
Name [1] 317344 0
Address [1] 317344 0
Country [1] 317344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314221 0
Sydney Local Health District Ethics Review Committee (RPA Zone)
Ethics committee address [1] 314221 0
Ethics committee country [1] 314221 0
Australia
Date submitted for ethics approval [1] 314221 0
27/11/2023
Approval date [1] 314221 0
30/01/2024
Ethics approval number [1] 314221 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130834 0
Dr Alyssa Milton
Address 130834 0
The University of Sydney, Professor Marie Bashir Centre, 67-73 Missenden Road, CAMPERDOWN NSW 2050
Country 130834 0
Australia
Phone 130834 0
+61 2 9515 1593
Fax 130834 0
Email 130834 0
[email protected]
Contact person for public queries
Name 130835 0
Alyssa Milton
Address 130835 0
The University of Sydney, Professor Marie Bashir Centre, 67-73 Missenden Road, CAMPERDOWN NSW 2050
Country 130835 0
Australia
Phone 130835 0
+61 2 9515 1593
Fax 130835 0
Email 130835 0
[email protected]
Contact person for scientific queries
Name 130836 0
Alyssa Milton
Address 130836 0
The University of Sydney, Professor Marie Bashir Centre, 67-73 Missenden Road, CAMPERDOWN NSW 2050
Country 130836 0
Australia
Phone 130836 0
+61 2 9515 1593
Fax 130836 0
Email 130836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are currently no plans to share data as this is a pilot study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.