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

NCT06894836 | Not Yet Recruiting Phase 2

• 2 other identifiers: 31083BFG012
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Depression Anxiety Disorder

Keywords

Virtual reality; Acceptance and commitment therapy; Youth mental health; Depression; Anxiety; Psychological intervention

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (20)

• Adverse events

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

• Feasibility - attendance rates of assessments and sessions

  12 weeks post intervention commencement

• Feasibility - VR utilisation

  12 weeks post intervention commencement

• Feasibility - intervention implementation

  12 weeks post intervention commencement

• Acceptability - intervention satisfaction

  12 weeks post intervention commencement

Study Arms (1)

Intervention

EXPERIMENTAL

Third wave VR intervention

Behavioral: Third wave VR therapy

Interventions

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.

Intervention

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Orygen: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• iMOGEN H Bell, PhD

  Orygen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imogen H Bell, PhD

CONTACT

+61430156222; imogen.bell@orygen.org.au

Jennifer Nicholas, PhD

CONTACT

+61 399 669 175; jennifer.nicholas@orygen.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow & Psychologist, Principal Investigator, PhD (Clin Psych)

Model Details: Single arm hybrid type 2 implementation-effectiveness trial

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share