Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000970549p
Ethics application status
Not yet submitted
Date submitted
25/07/2024
Date registered
9/08/2024
Date last updated
9/08/2024
Date data sharing statement initially provided
9/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivery and evaluation of a health and wellbeing programme for young people experiencing psychosis
Scientific title
Delivery and evaluation of the engagement of a health and wellbeing programme for young people experiencing psychosis
Secondary ID [1] 312617 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis (first episode/early) 334551 0
Condition category
Condition code
Mental Health 331157 331157 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12-week holistic health and wellbeing programme for rangatahi experiencing early psychosis. This will include a total of 24 delivery hours (12 x 2-hour weekly sessions) that include knowledge- or skill-based sessions (e.g., nutrition, living with medication) and physical activity sessions.

A physical workbook will be used to accompany the programme - this is currently in development with our design partners (Studio C) and our research team (including our lived experience team members). This workbook will provide interactive prompts for participants to reflect on their experiences of wellbeing whilst living with psychosis, and will align with the topics and sessions delivered. The nature of our co-design process means that 50% of the programme is confirmed (six sessions), with the remaining 50% to be co-designed prior to the programme. We have a core list of topics that will address: group forming (relationship building amongst the group through various activities); living with medication (information session); physical activity; (information and activity session); cooking and nutrition (information and activity session); understanding the role of spaces and places in wellbeing (information and activity session); and creative expression and identity-finding through art (activity session). Our facilitators are highly experienced in their respective areas, and include pharmacists, occupational therapists, exercise and nutrition professionals, and art therapists. We have identified potential session topics and facilitators for the remaining 50% of sessions, including nature walks, traditional Maori games (taonga takaro), but participants may also suggest additional topics and we will find facilitators for these sessions as and when they have been chosen. To address this fluid process, we have a risk management plan in place that have been developed alongside Early Intervention Services to safeguard participant wellbeing throughout the programme, which includes the continuous presence of an experienced clinical psychologist.

We have established a ‘home base’ from where the sessions will mainly be delivered - Akau Tangi recreation centre in Wellington - which contains the appropriate facilities. The programme will be delivered once, consisting of 12 sessions over the course of 14 weeks from March 2025 to June 2025 (accounting for two weeks for the Easter break). Adherence to the programme (or as we term it, ‘engagement’) is our primary variable of interest, and will be assessed via simple attendance checklists for each of the 15 participants.

For the physical activity sessions, we are not assessing level of exertion or any other self-reported or objective measures - this does not align with our mana-enhancing approach nor does it form part of our research questions. Our exercise professionals (staff from our delivery partners, Nuku Ora) will be delivering the majority physical activity sessions and will use their extensive experience to monitor safety throughout the sessions, including the appropriate Physical Activity Readiness Questionnaires. For some sessions that our participants might request, we will be sourcing these facilitators closer to the time (e.g., Maori game facilitators, Te Matau Ora), but our Nuku Ora staff will be ever-present throughout the programme. All physical activity sessions will be group sessions. To reiterate, we are not aiming to measure the effectiveness of physical activity to address any objective measures of health, but rather as a platform for social connection, engagement with the programme, and ultimately holistic self-perceived wellbeing.

In terms of the structure of the physical activity components, this is not strictly structured. In the context of our research question - we are not investigating any dose-response associated with physical activity - we are taking a flexible approach to the incorporation of physical activity within each session. Broadly, we have planned to have the first 60 minutes of each session for knowledge-based components and the second 60 minutes for physical activity, but this is likely to change on specific weekly content and is also dependent on what our participants would like - thus aligning to our participant-centred rather than prescriptive approach.

None of the activities or sessions described fall outside the scope of what is usually delivered to clients of Early Intervention Services; the purpose of this programme is to deliver in a structured, co-designed way and to purposefully investigate the effects of the programme on wellbeing.
Intervention code [1] 329127 0
Lifestyle
Intervention code [2] 329186 0
Behaviour
Intervention code [3] 329187 0
Treatment: Other
Comparator / control treatment
No control group;.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338920 0
Engagement with programme
Timepoint [1] 338920 0
Assessed for 12 weeks post-intervention commencement
Secondary outcome [1] 437904 0
Self-reported wellbeing
Timepoint [1] 437904 0
At baseline and at the programme end.
Secondary outcome [2] 437905 0
Perceived social connection
Timepoint [2] 437905 0
At baseline and programme end.
Secondary outcome [3] 437906 0
Health-Specific Self-Efficacy
Timepoint [3] 437906 0
At baseline and programme end.
Secondary outcome [4] 438230 0
Feasibility and acceptability of the programme
Timepoint [4] 438230 0
Post-programme completion (within 3 months, at a time convenient to the participant)

Eligibility
Key inclusion criteria
Participants must be: clients of early intervention services, diagnosed with first episiode psychosis; at least 16 years old.
Minimum age
16 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must be not experiencing an acute psychotic episode; and expected to remain a client of EIS for the duration of the programme.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
3/03/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 26459 0
New Zealand
State/province [1] 26459 0
Wellington

Funding & Sponsors
Funding source category [1] 317048 0
Government body
Name [1] 317048 0
New Zealand Health Research Council
Country [1] 317048 0
New Zealand
Funding source category [2] 317049 0
Government body
Name [2] 317049 0
Lottery Health Research Grant
Country [2] 317049 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 319296 0
University
Name [1] 319296 0
Victoria University Wellington
Address [1] 319296 0
Country [1] 319296 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315802 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315802 0
Ethics committee country [1] 315802 0
New Zealand
Date submitted for ethics approval [1] 315802 0
30/08/2024
Approval date [1] 315802 0
Ethics approval number [1] 315802 0

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

Contacts
Principal investigator
Name 135846 0
Dr Matthew Jenkins
Address 135846 0
University of Otago Wellington, 23 Mein Street, Newtown, Wellington, 6242
Country 135846 0
New Zealand
Phone 135846 0
+64 221740904
Fax 135846 0
Email 135846 0
[email protected]
Contact person for public queries
Name 135847 0
Matthew Jenkins
Address 135847 0
University of Otago Wellington, 23 Mein Street, Newtown, Wellington, 6242
Country 135847 0
New Zealand
Phone 135847 0
+64 221740904
Fax 135847 0
Email 135847 0
[email protected]
Contact person for scientific queries
Name 135848 0
Matthew Jenkins
Address 135848 0
University of Otago Wellington, 23 Mein Street, Newtown, Wellington, 6242
Country 135848 0
New Zealand
Phone 135848 0
+64 221740904
Fax 135848 0
Email 135848 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


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.