Virtual Reality Therapy for Anxiety

Overseen By Tsai Jack, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Psychological treatment, Epilepsy, Vision problems

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

100 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{2 5 8 9 10}

Research Team

Tsai Jack, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: gameChange Experimental Treatment 1 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

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. Malbos, E., Rapee, RM., Kavakli, M.[2011]

Virtual reality exposure therapy (VRET) was found to be more effective than no treatment for patients with panic disorder and agoraphobia, indicating its potential as a therapeutic intervention.

There was no significant difference in treatment outcomes between VRET delivered through a head-mounted display (HMD) and a computer automatic virtual environment (CAVE), suggesting that both methods are equally effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure treatment of agoraphobia: a comparison of computer automatic virtual environment and head-mounted display. Meyerbröker, K., Morina, N., Kerkhof, G., et al.[2011]

Virtual reality exposure therapy (VRET) has been shown to be highly effective for treating various anxiety-related disorders, with a large effect size of 0.90 compared to waitlist controls and 0.78 compared to psychological placebo conditions, based on a meta-analysis of 30 studies involving 1057 participants.

VRET's effectiveness is comparable to traditional in vivo exposure therapy, indicating that it can serve as an equally effective medium for exposure therapy across different anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. Carl, E., Stein, AT., Levihn-Coon, A., et al.[2020]

A review of 27 randomized controlled trials (RCTs) on virtual reality exposure therapy (VRET) for anxiety disorders found that the overall quality of the studies was low, with an average adherence to only 2.85 out of 8 research design criteria.

While VRET appears to be an effective treatment option, the variability in study quality and the reduction in effect size for larger sample sizes suggest that caution is needed when interpreting the results and comparing VRET to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. McCann, RA., Armstrong, CM., Skopp, NA., et al.[2022]

Virtual reality exposure therapy (VRET) is effective for treating agoraphobia and social phobia when conducted over 8 to 12 sessions, averaging once a week for at least 15 minutes, while specific phobias can be treated effectively in a single longer session lasting 45-180 minutes.

The effectiveness of VRET is enhanced when patients experience a high level of immersion in the virtual environment, and it shows sustained benefits over the long term, particularly in individuals without additional psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tips for Effective Implementation of Virtual Reality Exposure Therapy in Phobias-A Systematic Review. Krzystanek, M., Surma, S., Stokrocka, M., et al.[2021]

Virtual reality exposure therapy (VRET) has shown effectiveness in treating specific anxiety disorders, particularly fear of heights and flying, by immersing patients in a computer-generated environment.

However, the effectiveness of VRET for other phobias remains unclear, indicating a need for more randomized clinical trials to compare VRET directly with standard exposure therapy and to evaluate its efficacy as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy of anxiety disorders: a review. Krijn, M., Emmelkamp, PM., Olafsson, RP., et al.[2004]

Virtual reality exposure therapy (VRET) was found to be safe and effective in reducing dental anxiety, with no adverse events reported during the 14-week study involving ten patients.

Participants who underwent VRET showed a significant decrease in dental anxiety scores and behavioral avoidance compared to those who received an informational pamphlet, with many scheduling dental appointments after treatment, indicating a successful outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Exposure Therapy for the Treatment of Dental Phobia: A Controlled Feasibility Study. Gujjar, KR., van Wijk, A., Sharma, R., et al.[2019]

A single-session automated Virtual Reality exposure therapy (VRET) for fear of spiders demonstrated a significant reduction in phobia symptoms (effect size d = 1.26) in a study of 25 participants, with effects maintained at a six-month follow-up.

The intervention was found to be practical and tolerable, suggesting that automated VRET could serve as an effective self-help treatment for specific phobias in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders: A Single-Subject Trial Under Simulated Real-World Conditions. Lindner, P., Miloff, A., Bergman, C., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Automated Virtual Reality Cognitive Therapy (gameChange) in Inpatient Psychiatric Wards: Qualitative Study of Staff and Patient Views Using an Implementation Framework. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy does not provide any additional value in agoraphobic patients: a randomized controlled trial. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. [2011]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality exposure treatment of agoraphobia: a comparison of computer automatic virtual environment and head-mounted display. [2011]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Tips for Effective Implementation of Virtual Reality Exposure Therapy in Phobias-A Systematic Review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy of anxiety disorders: a review. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Exposure Therapy for the Treatment of Dental Phobia: A Controlled Feasibility Study. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders: A Single-Subject Trial Under Simulated Real-World Conditions. [2022]