Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000234415p
Ethics application status
Submitted, not yet approved
Date submitted
29/01/2025
Date registered
31/03/2025
Date last updated
31/03/2025
Date data sharing statement initially provided
31/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Single Group Open-Label Hybrid Type 2 Effectiveness-Implementation Trial of a Third Wave Virtual Reality Treatment for Youth Depression and Anxiety
Scientific title
Single Group Open-Label Hybrid Type 2 Effectiveness-Implementation Trial of a Third Wave Virtual Reality Treatment for Youth Depression and Anxiety
Secondary ID [1] 313676 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 336247 0
Depression 336248 0
Condition category
Condition code
Mental Health 332788 332788 0 0
Anxiety
Mental Health 332789 332789 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants in this trial will receive the VR intervention (i.e. single group trial). The VR intervention is adapted from third wave CBT protocols (including mindfulness and Acceptance and Commitment Therapy, or ACT) and focuses on decentering—the ability to step back and view thoughts and emotions as temporary, objective events rather than identifying with them. The VR intervention is designed for use in clinical settings and focuses on three core skills:

• Arousal reduction through controlled breathing.
• Sitting with uncomfortable thoughts and emotions without reacting.
• Cognitive defusion from negative thoughts by changing how they are perceived.

The intervention is delivered in-person, in a one-to-one format by a clinician with a young people, with five, 60 minute sessions over 10-12 weeks. Each session uses VR exercises to introduce and practice the skills described above, with the support of a clinician who will be in the room with the young person. The clinician cannot see what the young person is seeing however will be able to explain key concepts prior to entering the virtual environment, assist with VR use, and provide a debriefing after each exercise.

• Session 1 introduces the concepts behind decentering and explores how stepping back from thoughts and emotions can reduce distress. The VR component helps young people visualize and interact with their thoughts in a new way.
• Session 2 teaches arousal reduction through a controlled breathing exercise in VR, helping young people manage strong emotions.
• Session 3 focuses on acceptance of uncomfortable emotions by allowing participants to sit with difficult thoughts in VR, learning that these emotions will pass if they don’t react to them.
• Session 4 introduces cognitive defusion, where participants alter the physical representation of a negative thought in VR and engage in a game that reframes how they perceive the thought, making it less distressing.
• Session 5 involves a review and reinforcement of learning and revisiting any activities that may be beneficial.

Each session concludes with a discussion on how to apply the learned skills to real-life situations. This structured approach ensures that young people can easily integrate the skills into their daily lives. To record adherence to the protocol, clinicians will record whether the session was delivered according to the protocol in clinical notes. VR session use will also be recorded within the headset (time and date stamped).

Implementation strategy:
In addition to the VR intervention, an implementation strategy was developed to support implementation within routine youth mental health settings. Based on co-design sessions with clinicians, which explored anticipated barriers to using the VR intervention within mental health practice, we identified key barriers (e.g. clinician confidence with VR) to address with implementation support during the trial. With reference to the Expert Recommendations for Implementing Change, from this work, and conversations with participating services, the following implementation strategy was devised to support clinicians and services within the study.

Training:
Participating clinicians will receive in-person experiential training by an experienced VR therapist and researcher to deliver the VR intervention within sessions with young people. Training, and supporting materials, will be designed to increase clinicians' capability and confidence around technology, VR, and the five sessions of the VR intervention.

Supervision:
Participating clinicians will receive monthly, one-hour online supervision for VR-supported mental health care provision, in small groups, with an experienced clinical psychologist. Supervision supports challenges that may arise in the delivery of the VR intervention and any issues, questions, reflections that may arise from delivering care using technology.

Technical support:
Ongoing technological support will be available between 9 and 5pm to participating clinicians throughout the intervention period. VR developers with extensive experience in VR interventions and providing remote support to clinician and other stakeholders will be available to troubleshoot and enable the provision of the VR intervention.

Facilitation:
A locally based implementation facilitator will further support participating clinicians and their services to use the VR intervention through fortnightly calls or in-person drop ins (primary strategy to promote adherence). The facilitator is experienced supporting stakeholders to integrate digital tools in their clinical care and has established relationships with participating services. The facilitator will also be trained to support services with technical difficulties, should services encounter a problem that is unable to be supported by the remote technical support.
Intervention code [1] 330269 0
Behaviour
Intervention code [2] 330478 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340312 0
Feasibility - recruitment and consent rates
Timepoint [1] 340312 0
Baseline timepoint
Primary outcome [2] 340313 0
Acceptability - intervention endorsement
Timepoint [2] 340313 0
12 weeks post intervention commencement
Primary outcome [3] 340315 0
Effectiveness - severity of depression and anxiety
Timepoint [3] 340315 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [1] 443654 0
Adverse events
Timepoint [1] 443654 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [2] 443655 0
Feasibility - attendance rates of assessments and sessions
Timepoint [2] 443655 0
12 weeks post intervention commencement
Secondary outcome [3] 443656 0
Feasibility - VR utilisation
Timepoint [3] 443656 0
12 weeks post intervention commencement
Secondary outcome [4] 443657 0
Feasibility - intervention implementation
Timepoint [4] 443657 0
12 weeks post intervention commencement
Secondary outcome [5] 443658 0
Acceptability - intervention satisfaction
Timepoint [5] 443658 0
12 weeks post intervention commencement
Secondary outcome [6] 443659 0
Acceptability - therapeutic alliance
Timepoint [6] 443659 0
12 weeks post intervention commencement
Secondary outcome [7] 443661 0
Acceptability - cybersickness
Timepoint [7] 443661 0
12 weeks post intervention commencement
Secondary outcome [8] 443662 0
Acceptability - cybersickness within headset
Timepoint [8] 443662 0
Within each intervention session
Secondary outcome [9] 443664 0
Acceptability - VR presence
Timepoint [9] 443664 0
Within each intervention session
Secondary outcome [10] 443666 0
Implementation - adoption
Timepoint [10] 443666 0
12 weeks post intervention commencement
Secondary outcome [11] 443668 0
Implementation - determinants
Timepoint [11] 443668 0
At the end of the follow up period post week 16
Secondary outcome [12] 443669 0
Implementation - clinician confidence and competence assessed as a composite outcome
Timepoint [12] 443669 0
Before and after VR intervention training session
Secondary outcome [13] 443670 0
Implementation - fidelity
Timepoint [13] 443670 0
Continuous
Secondary outcome [14] 443672 0
Effectiveness - emotional distress
Timepoint [14] 443672 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [15] 443674 0
Effectiveness - goal attainment
Timepoint [15] 443674 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [16] 443675 0
Effectiveness - severity of repetitive negative thinking
Timepoint [16] 443675 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [17] 443676 0
Effectiveness - trait decentering
Timepoint [17] 443676 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [18] 443678 0
Effectiveness - state decentering
Timepoint [18] 443678 0
Measured within VR headset before and after each therapeutic exercise
Secondary outcome [19] 443679 0
Effectiveness - cognitive defusion
Timepoint [19] 443679 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [20] 443680 0
Effectiveness - psychological inflexibility
Timepoint [20] 443680 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [21] 443683 0
Effectiveness - quality of life
Timepoint [21] 443683 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcome [22] 443684 0
Effectiveness - wellbeing
Timepoint [22] 443684 0
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)

Eligibility
Key inclusion criteria
There are three populations recruited for this trial:

Young people
1. Aged between 12-25 years (inclusive)
2. Current client of a participating youth mental health service
3. Seeking or receiving treatment for depression and/or anxiety
4. Sufficient command of the English language

Clinicians
Employed at a participating youth mental health service and involved in the delivery of psychological treatment of young people presenting with depression and anxiety

Service staff
Work within a participating youth mental health service in a leadership (team lead or service manager) or administrative role.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young people
1. Moderate or severe audio or visual condition precluding engagement with the VR equipment (assessed on a case-by-case basis)
2. Counter indication based on clinical judgement e.g., active suicidal risk or intellectual disability.

Clinicians
Unable to commit to delivering the MIND intervention (5 sessions over 10-12 weeks).

Service staff
Nil

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/efficacy
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 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
1/04/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
20/07/2026
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318139 0
Government body
Name [1] 318139 0
Queensland Mental Health Commission - 2023-24 Better Futures Gran
Country [1] 318139 0
Australia
Primary sponsor type
University
Name
Orygen, University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320521 0
None
Name [1] 320521 0
Address [1] 320521 0
Country [1] 320521 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316784 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 316784 0
Ethics committee country [1] 316784 0
Australia
Date submitted for ethics approval [1] 316784 0
09/01/2025
Approval date [1] 316784 0
Ethics approval number [1] 316784 0

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

Contacts
Principal investigator
Name 139002 0
Dr Imogen Bell
Address 139002 0
Orygen, 35 Poplar Rd, Parkville VIC 3052
Country 139002 0
Australia
Phone 139002 0
+61430156222
Fax 139002 0
Email 139002 0
[email protected]
Contact person for public queries
Name 139003 0
Imogen Bell
Address 139003 0
Orygen, 35 Poplar Rd, Parkville VIC 3052
Country 139003 0
Australia
Phone 139003 0
+61430156222
Fax 139003 0
Email 139003 0
[email protected]
Contact person for scientific queries
Name 139004 0
Imogen Bell
Address 139004 0
Orygen, 35 Poplar Rd, Parkville VIC 3052
Country 139004 0
Australia
Phone 139004 0
+61430156222
Fax 139004 0
Email 139004 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data may be provided upon request to the main scientific contact.



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.