Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression/Anxiety

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-25
SponsorOrygen

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Third wave VR therapy

    Behavioral

    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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
12 weeks post intervention commencement
3

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.

Time frame
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
4

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.

Time frame
Time Frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)

Secondary outcomes

1

Adverse events

The number of serious adverse events specifically related to the intervention or trial

Time frame
Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
2

Feasibility - attendance rates of assessments and sessions

Record of attendance via audit of attendance logs

Time frame
12 weeks post intervention commencement
3

Feasibility - VR utilisation

Number and proportion of sessions within the intervention period in which VR was used within intervention sessions.

Time frame
12 weeks post intervention commencement
4

Feasibility - intervention implementation

Feasibility of Implementation Measure \[FIM\] (completed by service staff and clinicians)

Time frame
12 weeks post intervention commencement

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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