Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001312134
Ethics application status
Approved
Date submitted
21/08/2019
Date registered
26/09/2019
Date last updated
22/12/2021
Date data sharing statement initially provided
26/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a peer-led mental health recovery program
Scientific title
Better Together: Impact of a peer worker-led self-stigma program on mental health outcomes for community participants and the influence of context
Secondary ID [1] 298510 0
None
Universal Trial Number (UTN)
U1111-1235-4927
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness
 313309 0
Condition category
Condition code
Mental Health 311750 311750 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will use an interventional implementation science approach: small-scale, researcher-led implementation of a program to explore outcomes and contextual influences.

Program name
The trial is an evaluation of the Honest, Open, Proud program. There is only one intervention arm, which comprises the Honest, Open, Proud program. The program consists of nine tasks in three lessons, plus a follow-up booster session.

Timeframe
The delivery format is flexible, but is usually delivered in three weekly two-hour sessions, with the two-hour booster approximately 3-4 weeks later. Total participation time, including program sessions, outcome measures and the feedback session is approximately 10-12 hours across 8 weeks.

Procedures
The lesson content includes:
Lesson 1: Considering pros and cons of disclosing:
Task 1 - Do you identify yourself as a person with mental illness
Task 2 - Consider the pros and cons of disclosure

Lesson 2: Different ways to disclose:
Task 1 - Different ways to disclose
Task 2 - To whom might you disclose
Task 3 - How might others respond to your disclosure

Lesson 3: Telling your story:
Task 1 - How to tell your story
Task 2 - How did it go?
Task 3 - Honest, Open, Proud through peer support
Task 4 - Putting it all together

Booster
Follow-up 1 - The decision to disclose
Follow-up 2 - Peer support programs
Follow-up 3 - What has changed

Materials
Each session comprises information about stigma and disclosure, worksheets and activities that encourage participants to think about their own views and choices, weigh up pros and cons and to make informed choices.

Mode of delivery
The program will be delivered face-to-face and in small groups of approximately 8 participants. The group format allows for discussion of key points and practice sessions for disclosure and story-telling in a supportive environment, facilitated by peers with experience being "out".

Who will deliver the program?
The program will be delivered by peer workers trained in the Honest, Open, Proud program. Peer workers will be invited to participate in the study at a training event on the Honest, Open, Proud program, hosted by the investigator team. Training is anticipated to be a single day event, and will be completed prior to recruiting any participants into the program. These peer workers will also be invited to participate in the research, by providing their views on the implementation of the program. However, attendance at the training and delivery of the program will be independent of participation in the research (i.e. research participation is not a requirement of completing the training). It is anticipated that approximately eight peer workers will participate, including the three study investigators and the peer workers who have already expressed an interest in the study.

Location

Data collection is planned for three distinct settings within one Australian capital city: community-based public mental health services, a university and a recovery-focused adult mental health learning organisation (Recovery College).
Peer workers have recently been introduced into the city’s public mental health system, with positions in a variety of hospital and community-based settings. Group-based programs are already undertaken by at least one peer worker and opportunities exist to extend implementation to other peer workers. The program will be delivered and evaluated during usual peer work sessions.

The second planned setting is a university. The investigator team, who are all peer researchers and educators, will facilitate the Honest, Open, Proud program for staff and students of the university as part of the wellbeing program. The program will be held on campus at times agreed with participants to accommodate study and work responsibilities.
The third planned setting is a mental health Recovery College. The investigators and/or peer educators within the Recovery College will facilitate the program as part of 2019 second semester course offerings. The Recovery College has a specific focus on co-production and the importance of peer-led recovery, making it an ideal comparator for the other settings, in which these concepts are being introduced retrospectively.
Intervention code [1] 314761 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320437 0
The primary outcome is:
The success of the implementation of peer work roles across the settings.

The primary outcome is a study level outcome and will not be assessed for individual participants.

Peer work and the settings will be assessed using the Consolidated Framework for Implementation Research (CFIR), which provides a “menu of constructs” associated with successful implementation and allows systematic assessment of barriers and facilitators and the generation of theory.

Briefly, the CFIR consists of five core domains:
1. Intervention characteristics
2. Outer setting
3. Inner setting
4. Characteristics of individuals
5. Process.

Using the tools provided at www.cfirguide.org, including the interview guide builder, specific constructs of focus to investigate contextual influences for the current study across the five domains will be selected in collaboration with the ACACIA Consumer and Carer Advisory Group, and Canberra Health Services staff assisting with implementation. Expected constructs include adaptability and complexity of the intervention, external policy and incentives, inner setting culture and implementation climate, individual stage of change and all process constructs.
Timepoint [1] 320437 0
Assessed after the completion of the final 8-week follow-up for trial participants (i.e., when all data has been collected from trial participants).
Secondary outcome [1] 372039 0
Service level - Safety.

Investigated via interviews with staff and analysis of administrative data, including quality and safety monitoring, and routine outcome measurement statistics such as service level consumer experience data (e.g. the Your Experience of Service (YES) questionnaire) to assess overall changes to these figures following introduction of the peer workers and program.
This is a composite secondary outcome involving multiple sources of data.
Timepoint [1] 372039 0
Staff interviews and the analysis of administrative data will occur after completion of the final 8-week follow-up (i.e., when all data has been collected from trial participants).
Secondary outcome [2] 372040 0
Service level - Person-centredness

Investigated via interviews with staff and analysis of administrative data, including quality and safety monitoring, and routine outcome measurement statistics such as service level consumer experience data (e.g. the Your Experience of Service (YES) questionnaire) to assess overall changes to these figures following introduction of the peer workers and program.

This is a composite secondary outcome involving multiple sources of data.
Timepoint [2] 372040 0
Staff interviews and the analysis of administrative data will occur after completion of the final 8-week follow-up (i.e., when all data has been collected from trial participants).
Secondary outcome [3] 372041 0
Service level - Effectiveness

Investigated via interviews with staff and analysis of administrative data, including quality and safety monitoring, and routine outcome measurement statistics such as service level consumer experience data (e.g. the Your Experience of Service (YES) questionnaire) to assess overall changes to these figures following introduction of the peer workers and program.

This is a composite secondary outcome involving multiple sources of data. Consumer experience data, for example the YES questionnaire will be used to determine service level effectiveness of the program implementation.
Timepoint [3] 372041 0
Staff interviews and the analysis of administrative data will occur after completion of the final 8-week follow-up (i.e., when all data has been collected from trial participants)..
Secondary outcome [4] 372042 0
Individual level - self-stigma (first measure)

Measured by a specific self-stigma scale (Internalized Stigma of Mental Illness Inventory).
Timepoint [4] 372042 0
Baseline, post-program (3 weeks) and booster (~4 weeks after post)
Secondary outcome [5] 372043 0
Individual level - Empowerment

Measured by the Empowerment Scale
Timepoint [5] 372043 0
Baseline, post-program (3 weeks) and booster (~4 weeks after post)
Secondary outcome [6] 372044 0
Individual level - Recovery

Measured by the Self-Identified Stages of Recovery scale
Timepoint [6] 372044 0
Baseline, post-program (3 weeks) and booster (~4 weeks after post)
Secondary outcome [7] 372045 0
Individual level - Quality of life

Measured by the Personal Wellbeing Index (PWI)
Timepoint [7] 372045 0
Baseline, post-program (3 weeks) and booster (~4 weeks after post)
Secondary outcome [8] 372046 0
Individual Level - Distress

Measured by the Distress Questionnaire 5 (DQ5)
Timepoint [8] 372046 0
Baseline, post-program (3 weeks) and booster (~4 weeks after post)
Secondary outcome [9] 374116 0
Service level - Fidelity
Fidelity will be measured using the Honest, Open, Proud program's fidelity scale, scored by one investigator at each session. The evaluation questions are designed to gather information from program participants on the Honest, Open, Proud program, the delivery format (number and length of sessions), and the peer facilitators.

Timepoint [9] 374116 0
8 weeks after the baseline survey has been completed.
Secondary outcome [10] 374117 0
Service level - Feasibility and Acceptability
Integral to the participatory nature of both the program and the project is information about the peer delivery. The project investigators will record notes and reflections on their own experiences delivering the program as part of data collection. Other peer workers involved in program delivery will be invited to do the same, and to participate in an interview at the completion of each Honest, Open, Proud program to generate rich, cumulative data on the implementation process.

This is a composite secondary outcome involving multiple sources of data.
Timepoint [10] 374117 0
After the completion of the trial period when all data has been collected from trial participants (i.e., a minimum of 8 weeks after study commencement).
Secondary outcome [11] 374712 0
Individual level - self-stigma (second measure)
- Measured by a disclosure scale (Coming Out with Mental Illness Scale),

Timepoint [11] 374712 0
Baseline, post-program (3 weeks) and booster (~4 weeks after post)

Eligibility
Key inclusion criteria
There are three key groups for inclusion in the study who must be located in, and will be recruited from each selected setting we select to be a site for the study. The key sites for the study are: community-based public mental health services, a university and a recovery-focused adult mental health learning organisation (Recovery College).
1. Peer workers employed in each setting we select to be a site for the study.
2. Other staff members employed in each setting we select to be a site for the study involved in the peer worker program directly or indirectly.
3. People with self-identified lived experience of mental illness who attend at each setting we select to be a site for the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no specific exclusion criteria. However, the program and associated research project measures are all in English and approach the issues from a Western conceptualization of stigma and mental illness. As such, this may prove challenging for people from different cultural or language backgrounds. We will not specifically exclude these people from participating, but they may require extra assistance to take part.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As an exploratory study, no specific sample size calculations have been undertaken for individual outcomes. Based on medium-sized effects observed in previous studies trialing the Honest, Open, Proud program. we will aim for a minimum of three groups comprising eight participants per study setting (n=72) for the participants of the program (collecting both qualitative and quantitative data). We will also purposively interview up to 5 staff per setting (up to n=15), and will be offering an interview to the peer workers leading the program in each setting (up to n=8). This data will be qualitative only. Therefore the total sample is expected to be up to a total of n=95.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The trial element did not proceed any further due to the COVID-19 pandemic.
Date of first participant enrolment
Anticipated
1/10/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
1/03/2020
Actual
27/05/2021
Date of last data collection
Anticipated
1/05/2020
Actual
27/05/2021
Sample size
Target
95
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 303056 0
Government body
Name [1] 303056 0
National Health and Medical Research Council
Country [1] 303056 0
Australia
Primary sponsor type
Individual
Name
Dr Michelle Banfield
Address
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 303037 0
Individual
Name [1] 303037 0
Dr Amelia Gulliver
Address [1] 303037 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601
Australia
Country [1] 303037 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303719 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 303719 0
Ethics committee country [1] 303719 0
Australia
Date submitted for ethics approval [1] 303719 0
05/06/2019
Approval date [1] 303719 0
01/07/2019
Ethics approval number [1] 303719 0
2019/ETH/00105
Ethics committee name [2] 303720 0
The Australian National University Science and Medical Delegated Ethics Review Committee
Ethics committee address [2] 303720 0
Ethics committee country [2] 303720 0
Australia
Date submitted for ethics approval [2] 303720 0
09/08/2019
Approval date [2] 303720 0
03/09/2019
Ethics approval number [2] 303720 0
2019/411

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

Contacts
Principal investigator
Name 94234 0
Dr Michelle Banfield
Address 94234 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 94234 0
Australia
Phone 94234 0
+61261256547
Fax 94234 0
Email 94234 0
[email protected]
Contact person for public queries
Name 94235 0
Michelle Banfield
Address 94235 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 94235 0
Australia
Phone 94235 0
+61261256547
Fax 94235 0
Email 94235 0
[email protected]
Contact person for scientific queries
Name 94236 0
Michelle Banfield
Address 94236 0
Centre for Mental Health Research
Research School of Population Health
ANU College of Health and Medicine
63 Eggleston Road
The Australian National University
Acton ACT 2601 Australia
Country 94236 0
Australia
Phone 94236 0
+61261256547
Fax 94236 0
Email 94236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data generated from the study will be available for sharing.
When will data be available (start and end dates)?
Data associated with this project will be kept for 5 years after the last publication, at the end of the storage period, researcher notes will be de-identified (i.e. all person and organisation names removed) and archived for use in future research.
Available to whom?
Data will be available for use in future research with permission from the Principal Investigator (Michelle Banfield) or her nominated delegate.
Available for what types of analyses?
Requests can be made to the researcher as above. Requests will be considered on a case by case basis.
How or where can data be obtained?
https://datacommons.anu.edu.au/DataCommons/
Data will be made available only if request for access is approved by the researchers.
The contact details for the researchers will be available when applying for the data to be released from ANU Data Commons. You can contact [email protected] for queries related to this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2586Study protocol    We intend to publish the protocol for the trial. T... [More Details]



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