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Trial Review
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information for consumers
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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
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Scientific title
Evaluation of Lived Experience Peer Support Intervention for Mental Health Service Consumers in Primary Care
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Secondary ID [1]
310752
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
PS-PC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Health service research
331708
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Health promotion/education
331709
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Mental health disorders
331710
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Condition category
Condition code
Mental Health
328446
328446
0
0
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Addiction
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Mental Health
328447
328447
0
0
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Anxiety
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Mental Health
328452
328452
0
0
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Psychosis and personality disorders
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Mental Health
328453
328453
0
0
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Schizophrenia
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Mental Health
328458
328458
0
0
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Eating disorders
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Mental Health
328459
328459
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327163
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Treatment: Other
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Comparator / control treatment
No control group - single arm study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
336286
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Health self-efficacy of mental health care consumers.
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Assessment method [1]
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Generalised Self-Efficacy Scale (GSE; 10-items)
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Timepoint [1]
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3-months post-baseline
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Secondary outcome [1]
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Mental health care consumer mental distress
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Assessment method [1]
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Kessler psychological distress scale (K10; 10-items)
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Timepoint [1]
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Screening, 3-months post-baseline, 6-months post-baseline, 9-months post-baseline
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Secondary outcome [2]
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Mental health care consumer personal recovery
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Assessment method [2]
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Recovery Assessment Scale (RAS-DS; 38 items)
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Timepoint [2]
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Baseline, 3-months post-baseline, 6-months post-baseline, 9-months post-baseline
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Secondary outcome [3]
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Mental health care consumer quality of life
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Assessment method [3]
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EQ 5-Dimension scale (EQ-5D-5L; 5-items)
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Timepoint [3]
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Baseline, 3-months post-baseline, 6-months post-baseline, 9-months post-baseline
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Secondary outcome [4]
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Mental health care consumer satisfaction
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Assessment method [4]
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Adapted Your Experience of Service scale (YES; 15 items)
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Timepoint [4]
427668
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3-months post-baseline
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Secondary outcome [5]
427669
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Peer Worker self-efficacy
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Assessment method [5]
427669
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Generalised Self-Efficacy Scale (GSE; 10-items)
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Timepoint [5]
427669
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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.
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Secondary outcome [6]
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Caregiver impact
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Assessment method [6]
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Burden Scale for Family Caregivers (BSFC-s; 10 items)
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Timepoint [6]
427670
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Baseline, 3-months post-baseline
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Secondary outcome [7]
427671
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Practice Staff attitude toward Peer Workers, via scales informed by the Theoretical Framework of Acceptability (TFA).
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Assessment method [7]
427671
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Scales developed through study co-design and the TFA.
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Timepoint [7]
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Post-intervention: following the completion of clinic involvement in the study.
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Secondary outcome [8]
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Consumer perceived effectiveness of trial
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Assessment method [8]
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Scales informed through co-design and using the TFA. Further information from interviews held with consumer participants.
An invitation to be involved in semi-structured interviews will be sent to all enrolled participants. For each of the four study sites, the first five participants to opt-in to this additional component will be interviewed (i.e., total n = 20). Interviews of approximately 30 minutes will be performed by a member of the research team over Microsoft Teams, and will be audio-recorded using either Microsoft Teams or a digital recorder.
The content of the interviews will follow an interview guide specific to the perceived effectiveness of the trial (developed with reference to the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
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Timepoint [8]
427672
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Scales and interviews will be administered 3-months post-baseline.
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Secondary outcome [9]
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Family/Carer perceived effectiveness of trial
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Assessment method [9]
428134
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Scales informed through co-design and using the TFA. Further information from interviews and focus groups.
An invitation to be involved in semi-structured interviews will be sent to all family/carer participants. For each of the four study sites, the first two family/carer participants to opt-in to this additional component will be interviewed (i.e., total n = 8). Interviews of approximately 30 minutes will be performed by a member of the research team over Microsoft Teams, and will be audio-recorded using either Microsoft Teams or a digital recorder.
The content of the interviews will follow an interview guide specific to the perceived effectiveness of the trial (developed with reference to CFIR and the RE-AIM framework).
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Timepoint [9]
428134
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Scales and interviews will be administered 3-months post-baseline.
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Secondary outcome [10]
428135
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Peer Worker perceived effectiveness of trial.
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Assessment method [10]
428135
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Scales informed through co-design and using the CFIR. Further information from interviews held with peer workers.
An invitation to be involved in semi-structured interviews will be sent to all peer workers providing the intervention in this project. For each of the four study sites, the first two to three peer workers to opt-in to this additional component will be interviewed (total n = 10). A separate invitation to be involved in focus groups will be sent to all peer workers providing the intervention in this project. Two focus groups will be held with peer workers, of four to five peer workers in each (i.e., total n = 10).
Interviews of approximately 30 minutes and focus groups of approximately 1.5 hours will be administered by a member of the research team over Microsoft Teams. Each will be audio-recorded using either Microsoft Teams or a digital recorder.
The content of the interviews and focus groups will follow an interview guide specific to the perceived effectiveness of the trial (developed with reference to CFIR and the RE-AIM framework).
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Timepoint [10]
428135
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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.
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Secondary outcome [11]
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Practice Staff perceived effectiveness of trial
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Assessment method [11]
428136
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Scales informed through co-design and using the TFA. Further information from interviews and focus groups.
An invitation to be involved in semi-structured interviews will be sent to all practice staff at each study site, asking for staff to self-identify if they have had any involvement in the intervention. Those GPs involved in establishing the study (likely one from each study site, with one optional extra) will be invited to be interviewed (total n = 5). A separate invitation to be involved in interviews will be sent to practice staff. For each of the four study sites, the first three to four (non-GP) practice staff to opt-in to this additional component will be interviewed. Invitations to be involved in focus groups will be sent to all practice staff providing the intervention in this project (total n = 15). Four focus groups (one from each study site) will be held with practice staff (including GPs), of approximately six practice staff in each (i.e., total n = 24).
Interviews of approximately 30 minutes and focus groups of approximately 1.5 hours will be administered by a member of the research team over Microsoft Teams. Each will be audio-recorded using either Microsoft Teams or a digital recorder.
The content of the interviews and focus groups will follow an interview guide specific to the perceived effectiveness of the trial (developed with reference to CFIR and the RE-AIM framework).
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Timepoint [11]
428136
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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.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
9/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
264
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Accrual to date
2
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS
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Recruitment postcode(s) [1]
42027
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4552 - Maleny
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Recruitment postcode(s) [2]
42028
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5203 - Yankalilla
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Recruitment postcode(s) [3]
42029
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5341 - Renmark
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Recruitment postcode(s) [4]
42030
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7304 - Deloraine
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Funding & Sponsors
Funding source category [1]
314983
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
314983
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16 Marcus Clarke Street Canberra ACT 2601
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Country [1]
314983
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Australia
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Primary sponsor type
Individual
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Name
Prof Sharon Lawn
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Address
Flinders University, GPO Box 2100 Adelaide SA 5001
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Country
Australia
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Secondary sponsor category [1]
316990
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Individual
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Name [1]
316990
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Prof Paul Worley
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Address [1]
316990
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Flinders University, GPO Box 2100 Adelaide SA 5001
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Country [1]
316990
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Australia
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Secondary sponsor category [2]
316991
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Individual
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Name [2]
316991
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Ms Louise Byrne
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Address [2]
316991
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RMIT University, GPO Box 2476, Melbourne VIC 3001
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Country [2]
316991
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Australia
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Secondary sponsor category [3]
316992
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Individual
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Name [3]
316992
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A Prof Tania Shelby-James
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Address [3]
316992
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Flinders University, GPO Box 2100 Adelaide SA 5001
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Country [3]
316992
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Australia
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Secondary sponsor category [4]
316993
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Individual
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Name [4]
316993
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Dr Sam Manger
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Address [4]
316993
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James Cook University LPO, 150 Angus Smith Drive, DOUGLAS, QLD, 4814
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Country [4]
316993
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Australia
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Secondary sponsor category [5]
316994
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Individual
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Name [5]
316994
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Dr Vivian Isaac
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Address [5]
316994
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Flinders Rural Health SA – Renmark, PO Box 852, Renmark SA 5341
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Country [5]
316994
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Australia
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Secondary sponsor category [6]
316995
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Individual
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Name [6]
316995
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A Prof Billingsley Kaambwa
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Address [6]
316995
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Flinders University, GPO Box 2100 Adelaide SA 5001
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Country [6]
316995
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Australia
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Secondary sponsor category [7]
316996
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Individual
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Name [7]
316996
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Dr Shahid Ullah;
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Address [7]
316996
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Flinders University, GPO Box 2100 Adelaide SA 5001
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Country [7]
316996
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Australia
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Secondary sponsor category [8]
316997
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Individual
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Name [8]
316997
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Mr Bill Gye
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Address [8]
316997
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Community Mental Health Australia, PO Box 668 Rozelle NSW 2039
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Country [8]
316997
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Australia
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Secondary sponsor category [9]
316998
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Individual
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Name [9]
316998
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Dr Megan Rattray
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Address [9]
316998
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Flinders University, GPO Box 2100 Adelaide SA 5001
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Country [9]
316998
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Australia
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Secondary sponsor category [10]
316999
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Individual
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Name [10]
316999
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Ms Christine Kaine
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Address [10]
316999
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Lived Experience Australia, Australia
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Country [10]
316999
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Australia
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Secondary sponsor category [11]
317000
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Individual
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Name [11]
317000
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Dr Caroline Phegan
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Address [11]
317000
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Flinders University, GPO Box 2100 Adelaide SA 5001
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Country [11]
317000
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Australia
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Secondary sponsor category [12]
317001
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Individual
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Name [12]
317001
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Mr Geoff Harris
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Address [12]
317001
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Mental Health Coalition of SA, Level 5, Suite 2/195 North Terrace, North Adelaide SA 5000
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Country [12]
317001
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Australia
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Other collaborator category [1]
282842
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Individual
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Name [1]
282842
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Dr Belinda Fuss
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Address [1]
282842
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Flinders University, GPO Box 2100 Adelaide SA 5001
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Country [1]
282842
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313956
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Flinders University Human Research Ethics Committee
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Ethics committee address [1]
313956
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Flinders University, GPO Box 2100 Adelaide SA 5001; Australia
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Ethics committee country [1]
313956
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Australia
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Date submitted for ethics approval [1]
313956
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12/09/2023
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Approval date [1]
313956
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21/09/2023
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Ethics approval number [1]
313956
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6386
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Summary
Brief summary
Peer Workers have lived experience of mental ill-health and are intentionally employed to support individuals with mental ill-health as well as their family and carers. These Peer Workers are inaccessible to many in need, especially for those whose main or only support is through general practice. Our aim is to trial the implementation of a co-designed lived experience peer support intervention for mental health consumers in primary care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sharon Lawn
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Address
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Flinders University, GPO Box 2100, Adelaide, SA, 5001
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Country
129918
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Australia
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Phone
129918
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+61 4 5909 8772
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Fax
129918
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Email
129918
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[email protected]
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Contact person for public queries
Name
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Belinda Fuss
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Address
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Flinders University, GPO Box 2100, Adelaide, SA, 5001
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Country
129919
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Australia
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Phone
129919
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+61 8 8201 8535
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Fax
129919
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Email
129919
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[email protected]
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Contact person for scientific queries
Name
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Sharon Lawn
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Address
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Flinders University, GPO Box 2100, Adelaide, SA, 5001
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Country
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Australia
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Phone
129920
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+61 4 5909 8772
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Fax
129920
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Email
129920
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Ethical approval has not been obtained to share IPD.
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What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20622
Ethical approval
386715-(Uploaded-09-10-2023-15-13-20)-Study-related document.pdf
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20622
[Marked for deletion] Ethical approval
New Record*
Study protocol
Lawn, 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.
Download to PDF