Depression Anxiety DisorderPhase 2NCT06894836
Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression/Anxiety
A Phase 2 study testing Third wave VR therapy in people with Depression Anxiety Disorder, run by Orygen at 1 site in Australia.
Trial summary
This research will evaluate a new virtual reality (VR) intervention to support youth with depression and anxiety. While VR has shown promise for adult mental health, little is known about its use in youth or routine clinical care. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Depression Anxiety Disorder
- What is being tested?
- Third wave VR therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Apr 2025to 1 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Young people
- Aged between 12-25 years (inclusive)
- Current client of a participating youth mental health service
- Seeking or receiving treatment for depression and/or anxiety
- 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.
Who cannot join
- Young people
- Moderate or severe audio or visual condition precluding engagement with the VR equipment (assessed on a case-by-case basis)
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Orygen, Centre for Youth Mental Health, University of Melbourne
Parkville, Victoria, 3052
About this study
Official title: Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression and Anxiety
This research will evaluate a new virtual reality (VR) intervention to support youth with depression and anxiety. While VR has shown promise for adult mental health, little is known about its use in youth or routine clinical care. The VR intervention is based on Acceptance and Commitment Therapy (ACT) and immerses young people in fun, engaging environments to teach practical coping skills for managing distress. Clinicians within youth mental health services will use the VR intervention within their routine treatment of young people. The study will evaluate both the preliminary effectiveness of the VR intervention for improving youth mental health, as well as real-world implementation outcomes to understand how it can be successfully adopted in clinical settings. The trial will use a single-group, pre-post design, with treating clinicians delivering the intervention to up to 75 young people seeking treatment for depression and anxiety over a 12-week period. Assessments will be conducted at baseline, immediately after the intervention (12 weeks), and four weeks post-intervention (16 weeks).
Read the detailed description
Youth mental ill-health is a global crisis. One in five young people experience a mental health disorder every year, and suicide is a leading cause of death in this age group. In addition to costing the global economy $1 trillion per year in lost productivity, mental ill-health can have a severe and long-lasting impact on the lives of young people. Despite this, only a small proportion receive access to care, and of those that do, most fail to fully recover.
Technology has the potential to overcome many systemic barriers to accessing quality, sustainable care and importantly provide treatments tailored to young people's needs. In particular, virtual reality (VR) treatments have potential to tackle key limitations in youth mental health care. Through a VR headset, young people are transported into virtual environments that can provide powerful therapeutic experiences, enabling them to learn and practice skills to overcome mental health symptoms within personally relevant situations, under the safe and controlled supervision of a clinician. As a highly novel and interactive digital medium, VR has capacity to address barriers to help seeking and poor engagement amongst young people by delivering treatments that are fun, interesting and memorable. Meta analyses of randomised controlled trials have clearly supported the efficacy of VR treatments for improving mental health outcomes, however there are currently no available evidence-based options for youth and no studies have examined how VR treatments can be implemented in real world settings. This is a clear gap, with research demonstrating there is interest and need amongst clinicians and young people for innovative digital tools like VR to improve clinical care.
Through co-design with young people with lived experience and clinicians, a new VR treatment has been developed for youth depression and anxiety. Depression and anxiety are core transdiagnostic symptoms prominent in mood and anxiety disorders, which represent the most prevalent and debilitating mental health conditions with the highest burden of disease in youth populations. This new VR treatment is a blended clinical support tool which harnesses immersive VR environments to deliver targeted evidence-based treatment for depression and anxiety. Through engaging, interactive exercises, young people are guided to learn and practice core psychological skills based on ACT, an evidence-based treatment for youth depression and anxiety. Clinicians can use the third wave VR intervention within therapy sessions to help young people learn and practice these core skills in an engaging way, providing opportunities to improve treatment engagement, reduce drop out, and deliver a more effective learning experience that can translate into greater improvements in depression and anxiety in the real world.
Previous studies by our group included interviews with 30 young people and 10 clinicians which highlighted the perceived value of the third wave VR treatment for supporting clinical treatment by improving engagement and supporting therapeutic learning. An early experimental study [under review] with 20 young people found that a single session of MIND could improve negative mood states, with 100% of the sample preferring it to traditional therapy methods. As a next phase in this research, the current project aims to conduct a hybrid type 2 effectiveness-implementation trial to establish proof-of-concept evidence that the MIND intervention can be used to treat youth depression and anxiety within a routine youth mental health service setting. This trial design enables the simultaneous testing of implementation and effectiveness outcomes, thus accelerating the research to translation pipeline by seeking to understand how interventions can be implemented in real world settings.
The aims of this single-arm hybrid effectiveness-implementation pilot study are to:
- Assess the feasibility of the study protocol, including recruitment, retention, trial-related adverse events, and assessment completion.
- Evaluate the feasibility and acceptability of implementing the MIND intervention within routine youth mental health care settings, with a focus on intervention delivery, fidelity to the intervention model, and satisfaction levels among both participants and clinicians.
- Identify barriers and facilitators to implementing the MIND intervention in routine care settings, including implementation indicators relating to staff training, resource availability for delivery, organisational support, clinician perceptions, and logistical barriers and facilitators.
- Explore the preliminary effectiveness and safety of the MIND intervention by assessing changes over time in clinical outcomes, including measures of depression, anxiety, intervention mechanisms, quality of life, and intervention-related adverse events.
- Conditions
- Depression Anxiety Disorder
- Being tested
- Third wave VR therapy
- Keywords
- Virtual reality, Acceptance and commitment therapy, Youth mental health, Depression, Anxiety, Psychological intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third wave VR therapyBehavioural
All participants in this trial will receive the VR intervention which is adapted from third wave CBT protocols (including mindfulness and Acceptance and Commitment Therapy) and focuses on decentering-the ability to step back and view thoughts and emotions as temporary, objective events rather than identifying with them. Decentering has been linked to improved emotional regulation, reduced rumination, and better psychological flexibility, which in turn can lead to improvements in depression and anxiety symptoms. The intervention is clinician-delivered in a clinical setting, one-on-one, over 4-5 sessions (60 min each) across 10-12 weeks. Each session includes psychoeducation, a 15-minute VR experience, and debriefing. Sessions cover three core techniques targeting improvement in decentering ability: 1) arousal reduction via controlled breathing, 2) sitting with discomfort without reacting, and 3) cognitive defusion by changing perception of negative thoughts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Third wave VR intervention Receives: Behavioral: Third wave VR therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - recruitment and retention rates
Rates of how many participants sign up and are enrolled in the program, along with the drop-out rate throughout the program.
Measured: Baseline
Acceptability - intervention endorsement
Proportion of respondents who state they would recommend the intervention to other young people, measured using a purpose built self-report acceptability questionnaire. 1-5 scale, higher scores indicate higher likelihood or recommending to others.
Measured: 12 weeks post intervention commencement
Effectiveness - severity of depression
Mean pre-post scores, effect sizes and associated confidence intervals for the severity of depression assessed by the Patient Health Questionnaire-8 (PHQ-8). Range 0-28, higher indicates more severe depression.
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Effectiveness - severity of anxiety
Description: Mean pre-post scores, effect sizes and associated confidence intervals for the severity of anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7). Range 0-28, higher indicates more severe anxiety.
Measured: Time Frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcomes (20)
Adverse events
The number of serious adverse events specifically related to the intervention or trial
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Feasibility - attendance rates of assessments and sessions
Record of attendance via audit of attendance logs
Measured: 12 weeks post intervention commencement
Feasibility - VR utilisation
Number and proportion of sessions within the intervention period in which VR was used within intervention sessions.
Measured: 12 weeks post intervention commencement
Feasibility - intervention implementation
Feasibility of Implementation Measure [FIM] (completed by service staff and clinicians)
Measured: 12 weeks post intervention commencement
Acceptability - intervention satisfaction
Theoretical Framework of Acceptability Questionnaire (TFAQ) completed by young people, clinicians and service staff. Range 19-95, higher scores indicate greater acceptability.
Measured: 12 weeks post intervention commencement
Acceptability - therapeutic alliance
Working Alliance Inventory-Short Revised (WAI-SR). Range 12-60, higher scores indicating better working alliance between therapist and client.
Measured: 12 weeks post intervention commencement
Acceptability - cybersickness within headset
Average score on single item captured within VR headset during sessions requiring respondents toindicate the extent to which they felt uncomfortable, sick or dizzy (0 not at all to 10 very much)
Measured: Within each intervention session
Acceptability - VR presence
Average score on single item captured within VR headset during sessions requiring respondents to indicate the extent to which they felt present in the VR environment (0 not at all to 10 very much)
Measured: Within each intervention session
Implementation - adoption
Proportion of trained clinicians who implement MIND during the trial period.
Measured: 12 weeks post intervention commencement
Implementation - fidelity
Number of and attendance at, 1) facilitation meetings with services, 2) training sessions, and 3) supervision sessions, as well as number of technical support calls.
Measured: Measured during monthly meetings with services, during training sessions (immediately following clinician recruitment), monthly supervision sessions, and each time a support ticket is logged
Effectiveness - emotional distress
Kessler Psychological Distress Scale (K10). Range 10-50, higher indicates more severe emotional distress.
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Effectiveness - severity of repetitive negative thinking
Perseverative Thinking Questionnaire (PTQ). Range 0-60, higher indicates more severe repetitive negative thinking.
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - trait decentering
Metacognitive Processes of Decentering-Trait (MPoD-t). Range 15-75, higher scores indicate greater decentering ability.
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - state decentering
Metacognitive Processes of Decentering-State (MPoD-s). Range 0-30, higher score indicates greater decentering in the moment.
Measured: Measured within VR headset before and after each therapeutic exercise
Effectiveness - cognitive defusion
Cognitive Fusion Questionnaire (CFQ)
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - psychological inflexibility
Avoidance and Fusion Questionnaire - Youth (AFQ-Y). Range 0-32, higher scores indicate greater psychological inflexibility.
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - quality of life
Assessment of Quality-of-Life Scale (AQoL-6D) Adolescent. Score range from 0-1, higher scores indicate better quality of life.
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - wellbeing
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Range 14-70, higher scores indicating better wellbeing.
Measured: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Implementation - number and types of implementation determinants
Captured through process data related to clinical supervision and other study engagement points with participating clinicians and service staff (i.e. de-identified notes from supervision sessions, technical assistance calls, and research meetings), and via qualitative interviews with service staff , clinicians, and young people at the end of their involvement with the study.
Measured: Measured during monthly supervision meetings, all scheduled and unscheduled meetings, when a support ticket is logged, and end of study interviews with service staff, clinicians and young people (up to 1 year)
Implementation - clinician confidence and competence
Purpose-built scale (no title or acronym) capturing self-rated confidence and competence by clinicians. Scale items range 1-4, higher indicating stronger confidence and competence.
Measured: Immediately pre and post training, which occurs within 2 weeks of recruitment and consent of clinicians at the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm hybrid type 2 implementation-effectiveness trial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orygen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imogen Bell, Orygen
- Investigators
- iMOGEN H Bell, PhD, Principal investigator, Orygen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894836
- Sponsor's protocol ID
- 31083
- Other IDs
- BFG012
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Those interested in accessing data can contact the researchers directly to discuss this.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression and Anxiety
- ClinicalTrials.gov ID
- NCT06894836
- Acronym / sponsor ID
- 31083
- Conditions
- Depression Anxiety Disorder
- Keywords
- Virtual reality, Acceptance and commitment therapy, Youth mental health, Depression, Anxiety, Psychological intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- OrygenUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will evaluate a new virtual reality (VR) intervention to support youth with depression and anxiety. While VR has shown promise for adult mental health, little is known about its use in youth or routine clinical care. The VR intervention is based on Acceptance and Commitment Therapy (ACT) and immerses young people in fun, engaging environments to teach practical coping skills for managing distress. Clinicians within youth mental health services will use the VR intervention within their routine treatment of young people. The study will evaluate both the preliminary effectiveness of the VR intervention for improving youth mental health, as well as real-world implementation outcomes to understand how it can be successfully adopted in clinical settings. The trial will use a single-group, pre-post design, with treating clinicians delivering the intervention to up to 75 young people seeking treatment for depression and anxiety over a 12-week period. Assessments will be conducted at baseline, immediately after the intervention (12 weeks), and four weeks post-intervention (16 weeks).
Detailed description
Youth mental ill-health is a global crisis. One in five young people experience a mental health disorder every year, and suicide is a leading cause of death in this age group. In addition to costing the global economy $1 trillion per year in lost productivity, mental ill-health can have a severe and long-lasting impact on the lives of young people. Despite this, only a small proportion receive access to care, and of those that do, most fail to fully recover.
Technology has the potential to overcome many systemic barriers to accessing quality, sustainable care and importantly provide treatments tailored to young people's needs. In particular, virtual reality (VR) treatments have potential to tackle key limitations in youth mental health care. Through a VR headset, young people are transported into virtual environments that can provide powerful therapeutic experiences, enabling them to learn and practice skills to overcome mental health symptoms within personally relevant situations, under the safe and controlled supervision of a clinician. As a highly novel and interactive digital medium, VR has capacity to address barriers to help seeking and poor engagement amongst young people by delivering treatments that are fun, interesting and memorable. Meta analyses of randomised controlled trials have clearly supported the efficacy of VR treatments for improving mental health outcomes, however there are currently no available evidence-based options for youth and no studies have examined how VR treatments can be implemented in real world settings. This is a clear gap, with research demonstrating there is interest and need amongst clinicians and young people for innovative digital tools like VR to improve clinical care.
Through co-design with young people with lived experience and clinicians, a new VR treatment has been developed for youth depression and anxiety. Depression and anxiety are core transdiagnostic symptoms prominent in mood and anxiety disorders, which represent the most prevalent and debilitating mental health conditions with the highest burden of disease in youth populations. This new VR treatment is a blended clinical support tool which harnesses immersive VR environments to deliver targeted evidence-based treatment for depression and anxiety. Through engaging, interactive exercises, young people are guided to learn and practice core psychological skills based on ACT, an evidence-based treatment for youth depression and anxiety. Clinicians can use the third wave VR intervention within therapy sessions to help young people learn and practice these core skills in an engaging way, providing opportunities to improve treatment engagement, reduce drop out, and deliver a more effective learning experience that can translate into greater improvements in depression and anxiety in the real world.
Previous studies by our group included interviews with 30 young people and 10 clinicians which highlighted the perceived value of the third wave VR treatment for supporting clinical treatment by improving engagement and supporting therapeutic learning. An early experimental study [under review] with 20 young people found that a single session of MIND could improve negative mood states, with 100% of the sample preferring it to traditional therapy methods. As a next phase in this research, the current project aims to conduct a hybrid type 2 effectiveness-implementation trial to establish proof-of-concept evidence that the MIND intervention can be used to treat youth depression and anxiety within a routine youth mental health service setting. This trial design enables the simultaneous testing of implementation and effectiveness outcomes, thus accelerating the research to translation pipeline by seeking to understand how interventions can be implemented in real world settings.
The aims of this single-arm hybrid effectiveness-implementation pilot study are to:
- Assess the feasibility of the study protocol, including recruitment, retention, trial-related adverse events, and assessment completion.
- Evaluate the feasibility and acceptability of implementing the MIND intervention within routine youth mental health care settings, with a focus on intervention delivery, fidelity to the intervention model, and satisfaction levels among both participants and clinicians.
- Identify barriers and facilitators to implementing the MIND intervention in routine care settings, including implementation indicators relating to staff training, resource availability for delivery, organisational support, clinician perceptions, and logistical barriers and facilitators.
- Explore the preliminary effectiveness and safety of the MIND intervention by assessing changes over time in clinical outcomes, including measures of depression, anxiety, intervention mechanisms, quality of life, and intervention-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm hybrid type 2 implementation-effectiveness trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Third wave VR therapyThird wave VR intervention |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Young people
- Aged between 12-25 years (inclusive)
- Current client of a participating youth mental health service
- Seeking or receiving treatment for depression and/or anxiety
- Sufficient command of the English language
Key exclusion criteria (5 listed)
- Young people
- Moderate or severe audio or visual condition precluding engagement with the VR equipment (assessed on a case-by-case basis)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third wave VR therapyAll participants in this trial will receive the VR intervention which is adapted from third wave CBT protocols (including mindfulness and Acceptance and Commitment Therapy) and focuses on decentering-the ability to step back and view thoughts and emotions as temporary, objective events rather than identifying with them. Decentering has been linked to improved emotional regulation, reduced rumination, and better psychological flexibility, which in turn can lead to improvements in depression and anxiety symptoms. The intervention is clinician-delivered in a clinical setting, one-on-one, over 4-5 sessions (60 min each) across 10-12 weeks. Each session includes psychoeducation, a 15-minute VR experience, and debriefing. Sessions cover three core techniques targeting improvement in decentering ability: 1) arousal reduction via controlled breathing, 2) sitting with discomfort without reacting, and 3) cognitive defusion by changing perception of negative thoughts. | Behavioural | Intervention |
Primary outcome
Feasibility - recruitment and retention rates
Time frame: Baseline
Rates of how many participants sign up and are enrolled in the program, along with the drop-out rate throughout the program.
Acceptability - intervention endorsement
Time frame: 12 weeks post intervention commencement
Proportion of respondents who state they would recommend the intervention to other young people, measured using a purpose built self-report acceptability questionnaire. 1-5 scale, higher scores indicate higher likelihood or recommending to others.
Effectiveness - severity of depression
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Mean pre-post scores, effect sizes and associated confidence intervals for the severity of depression assessed by the Patient Health Questionnaire-8 (PHQ-8). Range 0-28, higher indicates more severe depression.
Effectiveness - severity of anxiety
Time frame: Time Frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Description: Mean pre-post scores, effect sizes and associated confidence intervals for the severity of anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7). Range 0-28, higher indicates more severe anxiety.
20 secondary outcomes
Adverse events
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Feasibility - attendance rates of assessments and sessions
Time frame: 12 weeks post intervention commencement
Feasibility - VR utilisation
Time frame: 12 weeks post intervention commencement
Feasibility - intervention implementation
Time frame: 12 weeks post intervention commencement
Acceptability - intervention satisfaction
Time frame: 12 weeks post intervention commencement
Acceptability - therapeutic alliance
Time frame: 12 weeks post intervention commencement
Acceptability - cybersickness within headset
Time frame: Within each intervention session
Acceptability - VR presence
Time frame: Within each intervention session
Implementation - adoption
Time frame: 12 weeks post intervention commencement
Implementation - fidelity
Time frame: Measured during monthly meetings with services, during training sessions (immediately following clinician recruitment), monthly supervision sessions, and each time a support ticket is logged
Effectiveness - emotional distress
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Effectiveness - severity of repetitive negative thinking
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - trait decentering
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - state decentering
Time frame: Measured within VR headset before and after each therapeutic exercise
Effectiveness - cognitive defusion
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - psychological inflexibility
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - quality of life
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Effectiveness - wellbeing
Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
Implementation - number and types of implementation determinants
Time frame: Measured during monthly supervision meetings, all scheduled and unscheduled meetings, when a support ticket is logged, and end of study interviews with service staff, clinicians and young people (up to 1 year)
Implementation - clinician confidence and competence
Time frame: Immediately pre and post training, which occurs within 2 weeks of recruitment and consent of clinicians at the start of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Those interested in accessing data can contact the researchers directly to discuss this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
iMOGEN H Bell, PhD principal investigator
Orygen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Third wave VR therapy in people with Depression Anxiety Disorder, run by Orygen at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - recruitment and retention rates (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.