Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12624001098527p
Ethics application status
Submitted, not yet approved
Date submitted
10/08/2024
Date registered
12/09/2024
Date last updated
12/09/2024
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).
Query!
Scientific title
Hearing Distressing Voices Simulation Workshop for regional (and rural) health and mental health workers: a feasibility Clinical Trial/Teletrial
Query!
Secondary ID [1]
312732
0
NIL KNOWN
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Auditory Hallucinations
334759
0
Query!
Hearing Distressing Voices
334760
0
Query!
Schizophrenia
334883
0
Query!
Bipolar disorder
334884
0
Query!
Condition category
Condition code
Mental Health
331317
331317
0
0
Query!
Other mental health disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
329253
0
Behaviour
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
339078
0
Change in empathy for voice-hearers
Query!
Assessment method [1]
339078
0
Modified version of the previously adapted Kiersma-Chen Empathy Scale completed at two time-points: at the beginning (pre-) and at the end of each educational workshop (post-). Participants will complete paper-based or online surveys per preference. The tool measures cognitive and affective empathy.
Aronson, B. D., Chen, A. M., Blakely, M., Kiersma, M. E., & Wicker, E. (2021). An update on the Kiersma Chen Empathy Scale (KCES): Creating the KCES-Revised. American Journal of Pharmaceutical Education, 86(5), 8685. https://doi.org/10.5688/ajpe8685 .
Query!
Timepoint [1]
339078
0
Assessment conducted at two time-points: at the beginning (pre-) and at the end of each workshop (post-).
Query!
Secondary outcome [1]
438482
0
Change in practice with voice-hearers
Query!
Assessment method [1]
438482
0
Questions from Level 1 and Level 2 of the Kirkpatrick Four Level Model of Evaluation (2019) will be used to assess cognitive learnings and change in practice. Baseline measures will be paper-based or online surveys (completely at the end of the workshop) and follow-up measures will be completed online via Teletrial with the assistance of Telehealth nurses.
Kirkpatrick Four Levels ® Model of Evaluation, 2019. https://www.kirkpatrickpartners.com/the-kirkpatrick-model/ (accessed on 20.07.2024)
Query!
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.
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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).
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
24/09/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
27/10/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
11/11/2026
Query!
Actual
Query!
Sample size
Target
90
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment postcode(s) [1]
42988
0
5608 - Whyalla Norrie East
Query!
Recruitment postcode(s) [2]
42989
0
5343 - Berri
Query!
Recruitment postcode(s) [3]
42990
0
5606 - Port Lincoln
Query!
Recruitment postcode(s) [4]
42991
0
5211 - Victor Harbor
Query!
Recruitment postcode(s) [5]
42992
0
5700 - Port Augusta West
Query!
Recruitment postcode(s) [6]
42993
0
5540 - Port Pirie
Query!
Recruitment postcode(s) [7]
42995
0
5290 - Mount Gambier
Query!
Funding & Sponsors
Funding source category [1]
317159
0
University
Query!
Name [1]
317159
0
The University of South Australia Department of Rural Health
Query!
Address [1]
317159
0
Query!
Country [1]
317159
0
Australia
Query!
Funding source category [2]
317160
0
Government body
Query!
Name [2]
317160
0
Australian Teletrial Program
Query!
Address [2]
317160
0
Query!
Country [2]
317160
0
Australia
Query!
Primary sponsor type
University
Query!
Name
The University of South Australia Department of Rural Health
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
319428
0
Government body
Query!
Name [1]
319428
0
The Australian Teletrial Program
Query!
Address [1]
319428
0
Query!
Country [1]
319428
0
Australia
Query!
Other collaborator category [1]
283135
0
University
Query!
Name [1]
283135
0
Flinders University Department of Rural Health
Query!
Address [1]
283135
0
Query!
Country [1]
283135
0
Australia
Query!
Other collaborator category [2]
283136
0
Other Collaborative groups
Query!
Name [2]
283136
0
Arana Pearson, Keepwell (Aust) PTY LDT
Query!
Address [2]
283136
0
Query!
Country [2]
283136
0
New Zealand
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
315909
0
University of South Australia Human Research Ethics Committee
Query!
Ethics committee address [1]
315909
0
https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/
Query!
Ethics committee country [1]
315909
0
Australia
Query!
Date submitted for ethics approval [1]
315909
0
10/08/2024
Query!
Approval date [1]
315909
0
Query!
Ethics approval number [1]
315909
0
ID 206384
Query!
Summary
Brief summary
The project aims to continue from a previous exploration. We will implement a feasibility clinical trial/teletrial to 1) determine the impact of having a co-facilitator with lived experience of voice-hearing sharing their experiences as part of the delivery method, on participants’ levels of empathy and 2) explore whether this translates to a change in practice. Workshops will be delivered in regional and remote South Australia and available to health and social care staff and undergraduate health sciences students.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
136182
0
Ms Lee MARTINEZ
Query!
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
Query!
Country
136182
0
Australia
Query!
Phone
136182
0
+61 408894942
Query!
Fax
136182
0
Query!
Email
136182
0
[email protected]
Query!
Contact person for public queries
Name
136183
0
Lee MARTINEZ
Query!
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
Query!
Country
136183
0
Australia
Query!
Phone
136183
0
+61 408894942
Query!
Fax
136183
0
Query!
Email
136183
0
[email protected]
Query!
Contact person for scientific queries
Name
136184
0
Lee MARTINEZ
Query!
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
Query!
Country
136184
0
Australia
Query!
Phone
136184
0
+61 408894942
Query!
Fax
136184
0
Query!
Email
136184
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
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.
Query!
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.
Download to PDF