Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000136505
Ethics application status
Approved
Date submitted
11/01/2024
Date registered
14/02/2024
Date last updated
14/02/2024
Date data sharing statement initially provided
14/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of a virtual reality treatment to improve social functioning in young people experiencing hallucinations
Scientific title
Virtual reality based cognitive behavioural therapy for young people experiencing
hallucinations: LINK feasibility and acceptability trial
Secondary ID [1] 311298 0
None
Universal Trial Number (UTN)
Trial acronym
LINK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early psychosis 332535 0
Schizophrenia 332536 0
Condition category
Condition code
Mental Health 329228 329228 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Revive – Hallucinations virtual reality (VR) treatment has been adapted from an existing
evidence based protocol for cognitive behavioural therapy for hallucinations (see Turner et al., 2020). This protocol involves a core focus on learning to cope with hallucinations in social situations in such a way that they no longer interfere with social functioning. The primary treatment activities involve addressing avoidance of social situations in which hallucinations are likely to be triggered, excessive attention to the hallucinations within social situations, and trying to suppress the hallucinations to the detriment of social participation. The treatment will be delivered one-on-one by a psychologist and involve using a VR headset within sessions. Within the VR, the participant will be immersed in a virtual environment that contains relevant social scenarios, such as a cafe, public transport or a lecture theatre. These environments were designed based on feedback from young people who have experiences of hallucinations and social anxiety who suggested they were the most relevant to their social difficulties. Session 1 will involve an orientation and explanation of the treatment process, and basic training in how to use the VR headset, and setting a personal social goal. Sessions 2 through 9 will involve working with the young person to map which of their current strategies to manage hallucinations in social situations to identify strategies which are counterproductive, and then replacing these with more effective coping strategies within the virtual environments. The therapist will guide young people through personally relevant social VR scenarios in order to identify, understand and address counter-productive strategies. Session 10 will involve a review of treatment progress and a focus on maintenance of gains following the end of the treatment. During VR scenarios, participants will be immersed into a personally selected VR environment that is relevant to their own social concerns (e.g. a cafe, university, bus). The participant can move around the environment and 'play out' social interactions by talking to an avatar. The avatar will play a roll in the situation, such as ordering a coffee from a barista or buying a ticket from a bus driver, and will be voiced by the therapist. The therapist can switch between speaking as themselves or the avatar.

The young person will be offered 10 sessions to complete over 10 weeks (1 x 1 hour session per week for 10 weeks). A post session log book will be kept by the therapist.
Intervention code [1] 327743 0
Behaviour
Intervention code [2] 327983 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337063 0
Feasibility - recruitment and consent rates
Timepoint [1] 337063 0
12 weeks post intervention commencement
Primary outcome [2] 337064 0
Acceptability - intervention endorsement
Timepoint [2] 337064 0
12 weeks post intervention commencement
Primary outcome [3] 337065 0
Safety - adverse events
Timepoint [3] 337065 0
Continuously throughout the trial and at 12 weeks post intervention
Secondary outcome [1] 430533 0
Feasibility - attendance rates of assessments and sessions
Timepoint [1] 430533 0
12 weeks post intervention commencement
Secondary outcome [2] 430534 0
Feasibility - Drop out rates
Timepoint [2] 430534 0
12 weeks post intervention commencement
Secondary outcome [3] 430535 0
Acceptability - satisfaction
Timepoint [3] 430535 0
12 weeks post intervention commencement
Secondary outcome [4] 430536 0
Cybersickness
Timepoint [4] 430536 0
At the end of sessions 4 and 8
Secondary outcome [5] 430537 0
Presence (a sense of ‘being there’ or ‘realness’)
Timepoint [5] 430537 0
At the end of sessions 4 and 8
Secondary outcome [6] 430538 0
Auditory hallucinations - severity
Timepoint [6] 430538 0
Baseline and 12 weeks post intervention commencement
Secondary outcome [7] 430539 0
Auditory hallucinations - beliefs
Timepoint [7] 430539 0
Baseline and 12 weeks post intervention commencement
Secondary outcome [8] 430544 0
Social functioning - Reaching a personal formulated Specific Measurable Achievable Realistic Time-bound (SMART) social goal
Timepoint [8] 430544 0
Session 1 and 12 weeks post intervention commencement
Secondary outcome [9] 430545 0
Social functioning - confidence and enjoyment
Timepoint [9] 430545 0
Baseline and 12 weeks post intervention commencement
Secondary outcome [10] 430546 0
Social functioning - overall
Timepoint [10] 430546 0
Baseline and 12 weeks post intervention commencement
Secondary outcome [11] 430547 0
Psychological needs
Timepoint [11] 430547 0
Baseline and 12 weeks post intervention commencement
Secondary outcome [12] 430548 0
Social functioning in daily life
Timepoint [12] 430548 0
Two identical EMA phases – in the week immediate following the baseline assessment session and in the week immediate following the post assessment

Eligibility
Key inclusion criteria
1) Any service users aged 16-25 within an early psychosis or ultra-high risk for psychosis service who are experiencing current hallucinations, defined by the occurrence of sensory experience in the absence of external stimuli, occurring at least once in the past month
2) The hallucinations are interfering with social functioning, as reported by the young person and/or clinician
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to communicate via English language
2) Recent change in mental health treatment, including new medication or initiation of psychological therapy within last 8 weeks
3) Moderate or severe intellectual disability as determined by the treating clinician
4) Moderate or severe audio or visual condition precluding engagement with the VR equipment
5) Current risk of harm to self or others, as judged by treating clinician
6) Current inpatient of a psychiatric hospital

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The primary outcomes of this study will be reported descriptively as summary statistics, including means and standard deviations (or equivalent) of feasibility and acceptability measures for each group. Pre - post changes in mental health measures will be conducted within each group using paired samples t-tests with associated p-values and effect sizes with confidence intervals for mean group differences (Cohen's d effect sizes). Specifically Cohen’s d effect sizes will be measured to determine the difference in pre-post scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
28/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25996 0
Orygen Youth Health - Parkville - Parkville
Recruitment hospital [2] 25997 0
Orygen Youth Health - Sunshine - Sunshine
Recruitment postcode(s) [1] 41845 0
3052 - Parkville
Recruitment postcode(s) [2] 41846 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 315552 0
Charities/Societies/Foundations
Name [1] 315552 0
Brain and Behaviour Research Fund (BBRF)
Country [1] 315552 0
United States of America
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
RMH City Campus, Level 2 South West 300 Grattan Street, Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 317640 0
None
Name [1] 317640 0
Address [1] 317640 0
Country [1] 317640 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314451 0
Royal Melbourne Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 314451 0
Ethics committee country [1] 314451 0
Australia
Date submitted for ethics approval [1] 314451 0
26/04/2023
Approval date [1] 314451 0
17/08/2023
Ethics approval number [1] 314451 0
HREC/92768/MH-2023

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

Contacts
Principal investigator
Name 131630 0
Dr Roos Pot-Kolder
Address 131630 0
Orygen Youth Health, 35 Poplar Rd, Parkville VIC 3052
Country 131630 0
Australia
Phone 131630 0
+61467670731
Fax 131630 0
Email 131630 0
[email protected]
Contact person for public queries
Name 131631 0
Roos Pot-Kolder
Address 131631 0
Orygen Youth Health, 35 Poplar Rd, Parkville VIC 3052
Country 131631 0
Australia
Phone 131631 0
+61467670731
Fax 131631 0
Email 131631 0
[email protected]
Contact person for scientific queries
Name 131632 0
Roos Pot-Kolder
Address 131632 0
Orygen Youth Health, 35 Poplar Rd, Parkville VIC 3052
Country 131632 0
Australia
Phone 131632 0
+61467670731
Fax 131632 0
Email 131632 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?
At the discretion the principle investigator, all of the individual participant data collected during the trial will be shared.
When will data be available (start and end dates)?
Once the study is completed (post May 2025) and will be available indefinitely
Available to whom?
At the discretion the principle investigator
Available for what types of analyses?
At the discretion the principle investigator, all of the de-identified individual participant data collected during the trial will be shared
How or where can data be obtained?
On request via email to [email protected]


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.