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Trial registered on ANZCTR


Registration number
ACTRN12624001098527
Ethics application status
Approved
Date submitted
10/08/2024
Date registered
12/09/2024
Date last updated
3/11/2024
Date data sharing statement initially provided
12/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
'Hearing Voices that are Distressing' (HVD) simulation workshop for regional (and rural) health and mental health workers practising in the health sector using a clinical trial (CT) leveraging from the regional Teletrial cluster model (National Australian Teletrial Program -ATP-SA) to build a higher level of evidence for lived experience (LE) added-value in simulation methods used for education and training for workers (and students).
Scientific title
Hearing Distressing Voices Simulation Workshop for regional (and rural) health and mental health workers: a feasibility Clinical Trial/Teletrial
Secondary ID [1] 312732 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auditory Hallucinations
334759 0
Hearing Distressing Voices 334760 0
Schizophrenia 334883 0
Bipolar disorder 334884 0
Condition category
Condition code
Mental Health 331317 331317 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The UniSA Department of Rural Health, in partnership with Flinders University Department of Rural Health and Keepwell Australia® New Zealand, will deliver a series of Hearing Voices that are Distressing (HVD) simulation workshops across sites in rural, regional, and remote South Australia (locations Whyalla, Victor Harbor, Berri, Port Augusta, Port Pirie, Port Lincoln, Mount Gambier). The half-day workshops are delivered in-person, and are based on Arana Pearson's (Keepwell Australia® New Zealand) authorised adaptation of Dr Patricia Deegan's Hearing Distressing Voices Simulation. HVD simulation workshops are divided into four parts: 1) a video introduction from Arana Pearson sharing his own story of voice-hearing, 2) a 45-minute theoretical lecture on current research and techniques that can be used to give voice-hearers power over their voices, and 3) a 35-45-minute simulation experience, and 4) a 30-minute debrief session with guided reflection.

Workshops will be co-facilitated by rural mental health academics and a person with a lived experience of hearing distressing voices. Three co-facilitators will deliver each workshop, the composition of which will either be 2x rural mental health academics with a lived experience co-facilitator (intervention group) or 3x rural mental health academics (standard delivery). All facilitators have prior experience delivering the workshop. Each workshop will include the same content, however workshops delivered to the intervention group will also include a lived experience co-facilitator sharing their story of hearing distressing voices and responding to participant questions.

Delivery sites will be randomized by an independent allocator, using computer-generated assignment, to determine which sites will receive the HVD simulation workshops delivered with a lived experience co-facilitator (intervention group, n=3 sites) and which will not (standard delivery, n=3 sites). Participants will be blinded to the site allocation; however, facilitators will be informed of the type of delivery each site will receive in order to prepare adequately.

To ensure intervention fidelity, all workshops will be delivered by 3x co-facilitators. All co-facilitators are trained and experienced in delivering the workshop. Sites allocated to the standard delivery arm will be delivered by the same co-facilitators, and vice versa. All workshops will include the same simulation experience, involving the same recording of distressing voices (delivered via MP3 players) and activities (i.e., undertaking a mental state assessment and engaging in cognitive or group-based activities). The same question prompts will be used in the guided reflection for both study arms. Co-facilitators will be asked to keep a reflective journal and record the amount of time spent on each component of the workshop at each delivery site.
Intervention code [1] 329253 0
Behaviour
Comparator / control treatment
The control group will receive the same Hearing Distressing Voices educational material but will not be exposed to a lived experience (LE) co-facilitator.
Control group
Active

Outcomes
Primary outcome [1] 339078 0
Change in empathy for voice-hearers
Timepoint [1] 339078 0
Assessment conducted at two time-points: at the beginning (pre-) and at the end of each workshop (post-).
Secondary outcome [1] 438482 0
Change in practice with voice-hearers
Timepoint [1] 438482 0
Assessment conducted at three time-points: immediately at the end of the workshop (T1) and at one-month (T2) and three-months (T3) post workshop.

Eligibility
Key inclusion criteria
Participants will be:
• Health and mental health staff working in regional (and rural) South Australia, including mental health professionals, as well as any support person who works with people who hear distressing voices.
• Aged 18 years and above.
• Enrolled in the HVD simulation workshop.
• Able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Workshop attendees who do not wish to participate in the research.
• Participants who have participated in the same workshop (in 2022 or earlier)
• Participants who have attended similar training using simulation techniques for distressing voices.

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)
An independent allocator (i.e., not one of the workshop facilitators) will randomise delivery sites to receive the intervention/standard delivery workshop using a computer program to generate assignment. Facilitators will be informed of the type of delivery each site will receive in order to prepare adequately, but will not be involved in the allocation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Delivery sites will be randomised by an independent allocator, using computer-generated assignment, to determine which sites will receive the HVD simulation workshops delivered with a lived experience co-facilitator (intervention group, n=3 sites) and which will not (standard delivery, n=3 sites).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
Quantitative data will be analysed using IBM SPSS statistics software version 29.
Descriptive data will be presented and reported using mean, standard deviation, median, range, or counts and percentages. Repeated measures analyses (ANOVA) will be used to determine the impact of participation in the workshops on changes in empathy and practice across time and to identify differences between groups (standard delivery vs. intervention).

The primary analysis is intended to determine whether conducting an RCT was feasible. Therefore all data will be descriptive and will include measurement of uncertainty such as 95% CI. The variance and effect of size differences (with 95%) will be calculated on the outcomes measures of cognitive learning and self-reported change of practice from baseline at the two follow-up points (one month and three months).

Qualitative data from the guided reflection (conducted as part of the workshop) will be subjected to thematic analysis, using an inductive approach and guided by Braun and Clarke’s six phase process (Braun and Clarke, 2006). The planned analysis will encompass the processes of immersion in the data set, coding to generate preliminary codes, the development of tentative themes, and reflection upon and revision of themes. This will be followed by a description of themes and sub-themes. Codes and themes will be reviewed by the research team at key points in the analysis. NVIVO Pro software version 12 will be used to facilitate coding.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/11/2024
Actual
Date of last participant enrolment
Anticipated
27/10/2026
Actual
Date of last data collection
Anticipated
11/11/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 42988 0
5608 - Whyalla Norrie East
Recruitment postcode(s) [2] 42989 0
5343 - Berri
Recruitment postcode(s) [3] 42990 0
5606 - Port Lincoln
Recruitment postcode(s) [4] 42991 0
5211 - Victor Harbor
Recruitment postcode(s) [5] 42992 0
5700 - Port Augusta West
Recruitment postcode(s) [6] 42993 0
5540 - Port Pirie
Recruitment postcode(s) [7] 42995 0
5290 - Mount Gambier

Funding & Sponsors
Funding source category [1] 317159 0
University
Name [1] 317159 0
The University of South Australia Department of Rural Health
Country [1] 317159 0
Australia
Funding source category [2] 317160 0
Government body
Name [2] 317160 0
Australian Teletrial Program
Country [2] 317160 0
Australia
Primary sponsor type
University
Name
The University of South Australia Department of Rural Health
Address
Country
Australia
Secondary sponsor category [1] 319428 0
Government body
Name [1] 319428 0
The Australian Teletrial Program
Address [1] 319428 0
Country [1] 319428 0
Australia
Other collaborator category [1] 283135 0
University
Name [1] 283135 0
Flinders University Department of Rural Health
Address [1] 283135 0
Country [1] 283135 0
Australia
Other collaborator category [2] 283136 0
Other Collaborative groups
Name [2] 283136 0
Arana Pearson, Keepwell (Aust) PTY LDT
Address [2] 283136 0
Country [2] 283136 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315909 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 315909 0
Ethics committee country [1] 315909 0
Australia
Date submitted for ethics approval [1] 315909 0
10/08/2024
Approval date [1] 315909 0
23/10/2024
Ethics approval number [1] 315909 0
ID 206384

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

Contacts
Principal investigator
Name 136182 0
Ms Lee MARTINEZ
Address 136182 0
Department of Rural Health | Allied Health and Human Performance | University of South Australia Whyalla Campus | 111 Nicolson Avenue | Whyalla Norrie | SA | 5608
Country 136182 0
Australia
Phone 136182 0
+61 408894942
Fax 136182 0
Email 136182 0
lee.martinez@unisa.edu.au
Contact person for public queries
Name 136183 0
Lee MARTINEZ
Address 136183 0
Department of Rural Health | Allied Health and Human Performance | University of South Australia Whyalla Campus | 111 Nicolson Avenue | Whyalla Norrie | SA | 5608
Country 136183 0
Australia
Phone 136183 0
+61 408894942
Fax 136183 0
Email 136183 0
lee.martinez@unisa.edu.au
Contact person for scientific queries
Name 136184 0
Lee MARTINEZ
Address 136184 0
Department of Rural Health | Allied Health and Human Performance | University of South Australia Whyalla Campus | 111 Nicolson Avenue | Whyalla Norrie | SA | 5608
Country 136184 0
Australia
Phone 136184 0
+61 408894942
Fax 136184 0
Email 136184 0
lee.martinez@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be de-identified and collated for each group (control vs. standard delivery). Individual participant data will not be shared to protect participant confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24309Ethical approval    388281-(Uploaded-02-11-2024-13-54-14)-206384_Approved protocol.pdf



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.