Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000881538p
Ethics application status
Submitted, not yet approved
Date submitted
18/06/2024
Date registered
19/07/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Designing and piloting an innovative mixed reality experience to deliver exposure therapy for contamination-related obsessive-compulsive disorder
Scientific title
Evaluating the acceptability, adherence, and efficacy of an innovative mixed reality experience to deliver exposure therapy for contamination-related obsessive-compulsive disorder in adults
Secondary ID [1] 312120 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-Compulsive Disorder 334136 0
Condition category
Condition code
Mental Health 330811 330811 0 0
Anxiety
Mental Health 331021 331021 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mixed reality-based exposure and response prevention (MERP) experience was designed by Liminal VR. It will be deployed on the Meta Quest 3, a mixed reality headset that superimposes computer-generated imagery on a real-world view. Within the program, participants will be exposed to and asked to interact with virtual contaminants projected onto a real table which are intended to trigger their contamination-related Obsessive-Compulsive Disorder (C-OCD) concerns. Participants will use their own hands to manipulate the virtual objects. There are three experiences in the exposure – abstract, realistic, and hyper-realistic. The abstract and hyper-realistic experiences will respectively use a half-eaten burger or a half-eaten mouldy burger as the contaminant, while the realistic experience will have a mouldy burger sealed in a plastic box as the contaminant. Each experience will be delivered once only and each take 5 minutes, and the order of experiences will be randomised for each participant. There will be a 5-minute break between each experience where participants will be asked to engage in a neutral filler task (spot the difference puzzles) while still wearing the headset.

After putting on the headset, at the start of each experience, participants will see virtual objects projected onto the table. This includes a virtual partition dividing the table into halves – on the left will be the contaminant (burger) with a blue block placed on top of it and a grey block on the table next to it; the right side will have four differently coloured blocks. Participants will be instructed to place their phone on the bottom right corner of the table. They will then be guided to look at the contaminant and to move the grey block to the right side of the table. Then, they will be prompted to move the blue block to the right side of the table and build a tower with all the blocks. Finally, they will be prompted to interact with their phone on the table by unlocking it and finding a photo that makes them feel neutral. Then the experience will end. The table will be cleaned prior to starting the ambiguous experience.

The student investigator will monitor participant adherence to the MERP experience, which will be accomplished by mirroring what the participant sees through their headset onto the student investigator’s phone using the Meta Quest application.
Intervention code [1] 328853 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338571 0
Treatment acceptability and adherence regarding MERP
Timepoint [1] 338571 0
Baseline and post-intervention (following completion of all experiences)
Primary outcome [2] 338572 0
State anxiety
Timepoint [2] 338572 0
9 times during the intervention (immediately before, midway, and immediately after each of the 3 experiences)
Primary outcome [3] 338786 0
Treatment acceptability and adherence regarding exposure and response prevention (ERP)
Timepoint [3] 338786 0
Baseline and post-intervention (following completion of all experiences)
Secondary outcome [1] 436493 0
Psychological flexibility
Timepoint [1] 436493 0
Baseline and post-intervention (following completion of all experiences)
Secondary outcome [2] 436494 0
Feedback on intervention
Timepoint [2] 436494 0
Post-intervention (following completion of all experiences)
Secondary outcome [3] 437453 0
Immersion in the mixed reality-based intervention - This is also an additional primary outcome
Timepoint [3] 437453 0
Post-intervention (following completion of all experiences)
Secondary outcome [4] 437454 0
State disgust - This is also an additional primary outcome
Timepoint [4] 437454 0
9 times during the intervention (immediately before, midway, and immediately after each of the 3 experiences)

Eligibility
Key inclusion criteria
Participants will be included in the study if they are aged between 18 and 80 years; meet current DSM-5 diagnostic criteria for OCD with one of their concerns being related to contamination; and fluency in English.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include a past or present diagnosis of schizophrenia-spectrum or bipolar disorder; a present substance use disorder; acute suicidality; have a cardiac pacemaker or other implanted medical device; have any serious pre-existing health conditions including heart conditions, traumatic brain injury, neck or spinal injury; a history of epilepsy or seizures or other epilepsy-like symptoms; impaired stereo-depth perception, uncorrected astigmatism, or other uncorrected binocular vision abnormalities; or are pregnant.

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
Efficacy
Statistical methods / analysis
Jamovi will be used to analyse the data. To assess feasibility and acceptability of the study (Hypothesis 1), descriptive statistics of scores on the TPI and post-intervention TAAS-M will be reviewed. In addition, paired samples t-tests will compare pre- and post-MERP scores on the anxiety and disgust VAS. To assess whether acceptability of MERP is positively associated with acceptability of in vivo ERP (Hypothesis 2), linear mixed effects modelling will be used to predict pre to post changes in TAAS-E from pre to post TAAS-M. We will also conduct a qualitative analysis on participant feedback on the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316477 0
University
Name [1] 316477 0
Swinburne University of Technology School of Health Sciences Small Research Grants (11.2711.33215)
Country [1] 316477 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 318979 0
None
Name [1] 318979 0
Address [1] 318979 0
Country [1] 318979 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315271 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 315271 0
Ethics committee country [1] 315271 0
Australia
Date submitted for ethics approval [1] 315271 0
28/06/2024
Approval date [1] 315271 0
09/08/2024
Ethics approval number [1] 315271 0
20247996-19317

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

Contacts
Principal investigator
Name 134186 0
Dr Kelvin (Shiu Fung) Wong
Address 134186 0
Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 134186 0
Australia
Phone 134186 0
+61 3 9214 5161
Fax 134186 0
Email 134186 0
[email protected]
Contact person for public queries
Name 134187 0
Kelvin (Shiu Fung) Wong
Address 134187 0
Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 134187 0
Australia
Phone 134187 0
+61 3 9214 5161
Fax 134187 0
Email 134187 0
[email protected]
Contact person for scientific queries
Name 134188 0
Kelvin (Shiu Fung) Wong
Address 134188 0
Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 134188 0
Australia
Phone 134188 0
+61 3 9214 5161
Fax 134188 0
Email 134188 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 of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
De-identified data will be available to other researchers on data sharing platforms (e.g., the Open Science Framework) and/or shared with colleagues for research purposes (e.g., meta-analyses).
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Unrestricted access via web address (https://osf.io/), access subject to approvals by Principal Investigator ([email protected]).


What supporting documents are/will be available?




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.