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Trial registered on ANZCTR


Registration number
ACTRN12623001189617
Ethics application status
Approved
Date submitted
11/10/2023
Date registered
17/11/2023
Date last updated
6/09/2024
Date data sharing statement initially provided
17/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Lived Experience Peer Support Intervention for Mental Health Service Consumers in Primary Care
Scientific title
Evaluation of Lived Experience Peer Support Intervention for Mental Health Service Consumers in Primary Care
Secondary ID [1] 310752 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PS-PC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health service research 331708 0
Health promotion/education 331709 0
Mental health disorders 331710 0
Condition category
Condition code
Mental Health 328446 328446 0 0
Addiction
Mental Health 328447 328447 0 0
Anxiety
Mental Health 328452 328452 0 0
Psychosis and personality disorders
Mental Health 328453 328453 0 0
Schizophrenia
Mental Health 328458 328458 0 0
Eating disorders
Mental Health 328459 328459 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-to-one peer support for mental healthcare consumers in primary care, delivered by lived experience peer workers. Depending on the needs of the individual, peer workers often provide support similar to an informal carer while using their personal experience and knowledge. however they also use their personal experience and knowledge in their support. They can provide information, a listening ear, company, and act as an advocate on the individual's behalf. Few resources are involved beyond the tools that peer workers use in the usual course of their employment (e.g., laptop computer, mobile phone etc.).

All participants will have access to 12 hours of support over a period three to four months, Some might use all 12 hours in the first month. Others might spread their time out across the given period (i.e., weekly or twice weekly). There is no set interval and this will vary based on preferences/needs. Face-to-face consultation will be prioritised. However, because the clinics are rural while the Community Managed Organisations (CMOs) are not, some flexibility is expected. Where it is not possible for a peer worker to travel to the participant, telehealth (videocalling) will be used. (For example, if a participant requests an immediate or next-day appointment.) Clinics will provide quiet consult rooms and make technology available to participants to ensure they have access.

Monitoring of adherence will be conducted through the peer worker. Where participants are not attending appointments (beyond the norm), the peer worker will contact their peer coordinator. There will also be constant communication between the project officer, peer worker coordinator, and practice staff to monitor adherence. Adherence will be monitored alongside potential for adverse events.
Intervention code [1] 327163 0
Treatment: Other
Comparator / control treatment
No control group - single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336286 0
Health self-efficacy of mental health care consumers.
Timepoint [1] 336286 0
3-months post-baseline
Secondary outcome [1] 427665 0
Mental health care consumer mental distress
Timepoint [1] 427665 0
Screening, 3-months post-baseline, 6-months post-baseline, 9-months post-baseline
Secondary outcome [2] 427666 0
Mental health care consumer personal recovery
Timepoint [2] 427666 0
Baseline, 3-months post-baseline, 6-months post-baseline, 9-months post-baseline
Secondary outcome [3] 427667 0
Mental health care consumer quality of life
Timepoint [3] 427667 0
Baseline, 3-months post-baseline, 6-months post-baseline, 9-months post-baseline
Secondary outcome [4] 427668 0
Mental health care consumer satisfaction
Timepoint [4] 427668 0
3-months post-baseline
Secondary outcome [5] 427669 0
Peer Worker self-efficacy
Timepoint [5] 427669 0
Pre-intervention: Orientation prior to their first session providing support; post-intervention: debrief following the final session providing support.

Some peer workers may provide support for several months, while some may only provide support for three to four months before disengaging from the study.
Secondary outcome [6] 427670 0
Caregiver impact
Timepoint [6] 427670 0
Baseline, 3-months post-baseline
Secondary outcome [7] 427671 0
Practice Staff attitude toward Peer Workers, via scales informed by the Theoretical Framework of Acceptability (TFA).
Timepoint [7] 427671 0
Post-intervention: following the completion of clinic involvement in the study.
Secondary outcome [8] 427672 0
Consumer perceived effectiveness of trial
Timepoint [8] 427672 0
Scales and interviews will be administered 3-months post-baseline.
Secondary outcome [9] 428134 0
Family/Carer perceived effectiveness of trial
Timepoint [9] 428134 0
Scales and interviews will be administered 3-months post-baseline.
Secondary outcome [10] 428135 0
Peer Worker perceived effectiveness of trial.
Timepoint [10] 428135 0
Interviews will be held in during the final months of a peer worker providing support, to gain insight while peer workers are providing support.

Scales and focus groups will be held post-intervention: debrief following the final session providing support.
Secondary outcome [11] 428136 0
Practice Staff perceived effectiveness of trial
Timepoint [11] 428136 0
Interviews will be held in during the final months of a clinic's involvement in the study, to gain insight while the study is active.

Scales and focus groups will be held post-intervention: debrief following the final session providing support.

Eligibility
Key inclusion criteria
A consumer is eligible to participate if they are 18 years of age or older, have a diagnosis of a mental health condition (or present with symptoms indicating the likelihood of a mental health condition), attend participating practices, willing to give informed consent to participate in the study and not already receiving peer support through an alternative funded programme will be eligibile for participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A consumer will be excluded if they have a significant mental or physical illness likely to disrupt capacity to participate in the trial (as measured by GP assessment of current suicidality risk and/or K10 cut of score of >40/50). Consumers who are unable to speak English and those unable to provide informed consent will also be excluded.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
264
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS
Recruitment postcode(s) [1] 42027 0
4552 - Maleny
Recruitment postcode(s) [2] 42028 0
5203 - Yankalilla
Recruitment postcode(s) [3] 42029 0
5341 - Renmark
Recruitment postcode(s) [4] 42030 0
7304 - Deloraine

Funding & Sponsors
Funding source category [1] 314983 0
Government body
Name [1] 314983 0
National Health and Medical Research Council
Country [1] 314983 0
Australia
Primary sponsor type
Individual
Name
Prof Sharon Lawn
Address
Flinders University, GPO Box 2100 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 316990 0
Individual
Name [1] 316990 0
Prof Paul Worley
Address [1] 316990 0
Flinders University, GPO Box 2100 Adelaide SA 5001
Country [1] 316990 0
Australia
Secondary sponsor category [2] 316991 0
Individual
Name [2] 316991 0
Ms Louise Byrne
Address [2] 316991 0
RMIT University, GPO Box 2476, Melbourne VIC 3001
Country [2] 316991 0
Australia
Secondary sponsor category [3] 316992 0
Individual
Name [3] 316992 0
A Prof Tania Shelby-James
Address [3] 316992 0
Flinders University, GPO Box 2100 Adelaide SA 5001
Country [3] 316992 0
Australia
Secondary sponsor category [4] 316993 0
Individual
Name [4] 316993 0
Dr Sam Manger
Address [4] 316993 0
James Cook University LPO, 150 Angus Smith Drive, DOUGLAS, QLD, 4814
Country [4] 316993 0
Australia
Secondary sponsor category [5] 316994 0
Individual
Name [5] 316994 0
Dr Vivian Isaac
Address [5] 316994 0
Flinders Rural Health SA – Renmark, PO Box 852, Renmark SA 5341
Country [5] 316994 0
Australia
Secondary sponsor category [6] 316995 0
Individual
Name [6] 316995 0
A Prof Billingsley Kaambwa
Address [6] 316995 0
Flinders University, GPO Box 2100 Adelaide SA 5001
Country [6] 316995 0
Australia
Secondary sponsor category [7] 316996 0
Individual
Name [7] 316996 0
Dr Shahid Ullah;
Address [7] 316996 0
Flinders University, GPO Box 2100 Adelaide SA 5001
Country [7] 316996 0
Australia
Secondary sponsor category [8] 316997 0
Individual
Name [8] 316997 0
Mr Bill Gye
Address [8] 316997 0
Community Mental Health Australia, PO Box 668 Rozelle NSW 2039
Country [8] 316997 0
Australia
Secondary sponsor category [9] 316998 0
Individual
Name [9] 316998 0
Dr Megan Rattray
Address [9] 316998 0
Flinders University, GPO Box 2100 Adelaide SA 5001
Country [9] 316998 0
Australia
Secondary sponsor category [10] 316999 0
Individual
Name [10] 316999 0
Ms Christine Kaine
Address [10] 316999 0
Lived Experience Australia, Australia
Country [10] 316999 0
Australia
Secondary sponsor category [11] 317000 0
Individual
Name [11] 317000 0
Dr Caroline Phegan
Address [11] 317000 0
Flinders University, GPO Box 2100 Adelaide SA 5001
Country [11] 317000 0
Australia
Secondary sponsor category [12] 317001 0
Individual
Name [12] 317001 0
Mr Geoff Harris
Address [12] 317001 0
Mental Health Coalition of SA, Level 5, Suite 2/195 North Terrace, North Adelaide SA 5000
Country [12] 317001 0
Australia
Other collaborator category [1] 282842 0
Individual
Name [1] 282842 0
Dr Belinda Fuss
Address [1] 282842 0
Flinders University, GPO Box 2100 Adelaide SA 5001
Country [1] 282842 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313956 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 313956 0
Ethics committee country [1] 313956 0
Australia
Date submitted for ethics approval [1] 313956 0
12/09/2023
Approval date [1] 313956 0
21/09/2023
Ethics approval number [1] 313956 0
6386

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

Contacts
Principal investigator
Name 129918 0
Prof Sharon Lawn
Address 129918 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 129918 0
Australia
Phone 129918 0
+61 4 5909 8772
Fax 129918 0
Email 129918 0
[email protected]
Contact person for public queries
Name 129919 0
Belinda Fuss
Address 129919 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 129919 0
Australia
Phone 129919 0
+61 8 8201 8535
Fax 129919 0
Email 129919 0
[email protected]
Contact person for scientific queries
Name 129920 0
Sharon Lawn
Address 129920 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 129920 0
Australia
Phone 129920 0
+61 4 5909 8772
Fax 129920 0
Email 129920 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
Ethical approval has not been obtained to share IPD.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20622Ethical approval    386715-(Uploaded-09-10-2023-15-13-20)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20622[Marked for deletion] Ethical approval   
New Record*Study protocolLawn, S., Shelby-James, T., Manger, S. et al. Evaluation of lived experience Peer Support intervention for mental health service consumers in Primary Care (PS-PC): study protocol for a stepped-wedge cluster randomised controlled trial. Trials 25, 319 (2024). https://doi.org/10.1186/s13063-024-08165-y 

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.