About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Third wave VR therapy
BehavioralAll 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Adverse events
The number of serious adverse events specifically related to the intervention or trial
Feasibility - attendance rates of assessments and sessions
Record of attendance via audit of attendance logs
Feasibility - VR utilisation
Number and proportion of sessions within the intervention period in which VR was used within intervention sessions.
Feasibility - intervention implementation
Feasibility of Implementation Measure \[FIM\] (completed by service staff and clinicians)
Locations
This trial is not recruiting at the moment. You can still explore other options: