Clinical trial NCT06894836: Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression/Anxiety
Official title: Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Depression Anxiety Disorder
Keywords: Virtual reality
Acceptance and commitment therapy
Youth mental health
Depression
Anxiety
Psychological intervention
Lead sponsor: Orygen
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm hybrid type 2 implementation-effectiveness trial
Primary purpose: TREATMENT

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).

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:

1. Assess the feasibility of the study protocol, including recruitment, retention, trial-related adverse events, and assessment completion.
2. 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.
3. 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.
4. 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.

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

INCLUSION CRITERIA

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.

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

Primary outcomes:
measure: Feasibility - recruitment and retention rates
timeFrame: Baseline
measure: Acceptability - intervention endorsement
timeFrame: 12 weeks post intervention commencement
measure: Effectiveness - severity of depression
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
measure: Effectiveness - severity of anxiety
timeFrame: Time Frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
Secondary outcomes:
measure: Adverse events
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
measure: Feasibility - attendance rates of assessments and sessions
timeFrame: 12 weeks post intervention commencement
measure: Feasibility - VR utilisation
timeFrame: 12 weeks post intervention commencement
measure: Feasibility - intervention implementation
timeFrame: 12 weeks post intervention commencement
measure: Acceptability - intervention satisfaction
timeFrame: 12 weeks post intervention commencement
measure: Acceptability - therapeutic alliance
timeFrame: 12 weeks post intervention commencement
measure: Acceptability - cybersickness within headset
timeFrame: Within each intervention session
measure: Acceptability - VR presence
timeFrame: Within each intervention session
measure: Implementation - adoption
timeFrame: 12 weeks post intervention commencement
measure: Implementation - fidelity
timeFrame: Measured during monthly meetings with services, during training sessions (immediately following clinician recruitment), monthly supervision sessions, and each time a support ticket is logged
measure: Effectiveness - emotional distress
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)
measure: Effectiveness - severity of repetitive negative thinking
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
measure: Effectiveness - trait decentering
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
measure: Effectiveness - state decentering
timeFrame: Measured within VR headset before and after each therapeutic exercise
measure: Effectiveness - cognitive defusion
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
measure: Effectiveness - psychological inflexibility
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
measure: Effectiveness - quality of life
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
measure: Effectiveness - wellbeing
timeFrame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)
measure: Implementation - number and types of implementation determinants
timeFrame: 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)
measure: Implementation - clinician confidence and competence
timeFrame: Immediately pre and post training, which occurs within 2 weeks of recruitment and consent of clinicians at the start of the study
Other outcomes:
Locations:
Study officials:
affiliation: Orygen
name: iMOGEN H Bell, PhD
role: PRINCIPAL_INVESTIGATOR
References: