100 Participants Needed

Virtual Reality Therapy for Anxiety

AL
TJ
Overseen ByTsai Jack, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving psychological treatment for anxiety, you are not eligible to participate.

Is virtual reality therapy safe for treating anxiety?

Research on virtual reality exposure therapy (VRET) for anxiety disorders suggests it is generally safe for humans, as it has been tested in various studies without significant safety concerns reported. However, the quality of these studies varies, and more well-designed research is needed to confirm its safety and effectiveness.12345

How is gameChange VR Therapy different from other anxiety treatments?

gameChange VR Therapy is unique because it uses virtual reality to immerse patients in a computer-generated environment, allowing them to confront their fears in a controlled setting without needing real-world exposure. This can make it more accessible and less intimidating than traditional exposure therapy, which requires facing fears in real life.23678

What data supports the effectiveness of the treatment gameChange VR Therapy for anxiety?

Research shows that virtual reality exposure therapy (VRET) is effective for anxiety-related disorders, with a large effect size compared to no treatment and a medium to large effect size compared to placebo. This suggests that gameChange VR Therapy, which uses similar principles, could be effective for treating anxiety.235910

Who Is on the Research Team?

TJ

Tsai Jack, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for students at The University of Texas Health Science Center School of Public Health San Antonio campus who can speak English and have a mild level of anxiety. Students with photosensitive epilepsy, vision or balance issues, or those currently in therapy for anxiety or who were treated within the last year cannot participate.

Inclusion Criteria

Competent in English
Enrolled in The University of Texas Health Science Center School of Public Health San Antonio regional campus
Total score of at least 3 on the Generalized Anxiety Disorder (GAD-2)

Exclusion Criteria

Reports photosensitive epilepsy
I am currently in therapy for anxiety or have been within the last year.
I experience issues with my vision or balance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo six virtual reality therapy sessions to assess changes in anxiety and academic self-efficacy

3 weeks
6 sessions (virtual)

Follow-up

Participants are monitored for changes in anxiety-related behaviors and academic performance

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • gameChange
Trial Overview The study is testing 'gameChange', a virtual reality therapy program, to see if it helps reduce anxiety symptoms over six sessions within three weeks. It also looks at how this VR treatment might improve students' confidence in their academic abilities.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: gameChangeExperimental Treatment1 Intervention

gameChange is already approved in United Kingdom, United States for the following indications:

🇬🇧
Approved in United Kingdom as gameChange for:
  • Anxiety disorders
  • Social anxiety disorder
🇺🇸
Approved in United States as gameChange for:
  • Anxiety disorders
  • Social anxiety disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Published Research Related to This Trial

Patients and staff expressed strong enthusiasm for the gameChange VR therapy on psychiatric wards, believing it could help build confidence and reduce anxiety as patients prepare for discharge.
The main barrier to implementing VR therapy was the need for sufficient private space, but overall, both patients and staff felt that VR could be integrated into current care with proper support and training.
Automated Virtual Reality Cognitive Therapy (gameChange) in Inpatient Psychiatric Wards: Qualitative Study of Staff and Patient Views Using an Implementation Framework.Brown, P., Waite, F., Lambe, S., et al.[2023]
In a study involving 55 patients with panic disorder and agoraphobia, both virtual reality exposure therapy (VRET) and traditional exposure in vivo were found to be significantly more effective than no treatment, but VRET did not outperform exposure in vivo on most measures.
While VRET and exposure in vivo showed similar therapeutic processes, exposure in vivo was slightly more effective, suggesting that VRET may not be the best option for treating agoraphobia at this time due to its higher costs and lack of long-term follow-up data.
Virtual reality exposure therapy does not provide any additional value in agoraphobic patients: a randomized controlled trial.Meyerbroeker, K., Morina, N., Kerkhof, GA., et al.[2019]
Virtual Reality Based Exposure Therapy (VRBET) showed positive effects in treating agoraphobia in a trial with 10 participants, indicating its potential as an effective standalone treatment.
Combining VRBET with cognitive therapy did not result in significant improvements over VRBET alone, suggesting that VRBET may be sufficient for addressing agoraphobia without the need for additional cognitive interventions.
Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial.Malbos, E., Rapee, RM., Kavakli, M.[2011]

Citations

Automated Virtual Reality Cognitive Therapy (gameChange) in Inpatient Psychiatric Wards: Qualitative Study of Staff and Patient Views Using an Implementation Framework. [2023]
Virtual reality exposure therapy does not provide any additional value in agoraphobic patients: a randomized controlled trial. [2019]
Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. [2011]
Virtual reality exposure treatment of agoraphobia: a comparison of computer automatic virtual environment and head-mounted display. [2011]
Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. [2020]
Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. [2022]
Tips for Effective Implementation of Virtual Reality Exposure Therapy in Phobias-A Systematic Review. [2021]
Virtual reality exposure therapy of anxiety disorders: a review. [2004]
Virtual Reality Exposure Therapy for the Treatment of Dental Phobia: A Controlled Feasibility Study. [2019]
Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders: A Single-Subject Trial Under Simulated Real-World Conditions. [2022]
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