Virtual Reality Anxiety Study

Overseen By Sonja Hiller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Non-native English speaker, others

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for anxiety?

Research shows that Virtual Reality Exposure Therapy (VRET) is effective for treating anxiety disorders by providing controlled, immersive experiences that are often more acceptable to patients than traditional methods. Studies indicate that VRET can enhance the ease and effectiveness of exposure therapy, making it a promising tool for anxiety treatment. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating anxiety disorders?

Virtual reality therapy for anxiety disorders is generally considered safe, with side effects similar to motion sickness in some cases, but it is as effective and safe as traditional exposure therapy. ^{6 7 8 9 10}

How is the Brain Activity Monitoring for Anxiety treatment different from other anxiety treatments?

This treatment is unique because it uses virtual reality (VR) combined with biofeedback to help patients learn to control their physiological responses to anxiety. Unlike traditional therapies, it provides real-time feedback in a virtual environment, allowing patients to practice emotional regulation and relaxation through interactive and immersive experiences. ^{4 9 11 12 13}

Eligibility Criteria

This trial is for adults who can read and write English fluently, are willing to consent to participate, and have had specific neurostimulation electrode placement. It's not suitable for non-native English speakers or those unwilling to consent.

Inclusion Criteria

I am 18 years old or older.

Willing to provide informed consent and participate in the study

Ability to read and write English fluently

Exclusion Criteria

You have not had electrodes implanted for acute depth or chronic responsive neurostimulation treatment.

English is not my first language.

Unwilling to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete computer-based tasks while their brain activity, heart rate, and skin perspiration are measured. Some tasks involve a virtual reality headset.

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Computer-based tasks
• Virtual reality tasks

Trial Overview The study aims to understand brain mechanisms behind fear and anxiety by measuring brain activity, heart rate, and skin perspiration during computer tasks. Some tasks involve virtual reality with exposure to fear-inducing images.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

VA Greater Los Angeles Healthcare System

Collaborator

Trials

53

Recruited

8,700+

NeuroPace

Industry Sponsor

Trials

11

Recruited

1,500+

Findings from Research

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 (VR) shows promise as an effective assessment and treatment tool for anxiety disorders, including post-traumatic stress disorder and obsessive-compulsive disorder, but its use in clinical practice remains limited despite rapid advancements in technology.

VR is particularly appealing for younger patients due to its engaging and playful elements, which may facilitate treatment and preventive interventions, highlighting the need for further research and integration into clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of virtual reality in assessment and treatment of anxiety and related disorders. Meyerbröker, K., Morina, N.[2021]

Virtual reality (VR) is an effective and immersive tool for treating psychiatric disorders, particularly anxiety, by providing controlled sensory stimulation in a three-dimensional environment.

The review highlights the empirical evidence supporting VR-based interventions and suggests that VR can be a convenient and cost-effective addition to traditional psychiatric treatments, with recommendations for its integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Maples-Keller, JL., Bunnell, BE., Kim, SJ., et al.[2022]

A systematic review of 28 studies indicates that head-mounted display virtual reality (HMD-VR) is an effective tool for treating various anxiety disorders, including specific phobias and social anxiety, through virtual reality exposure therapy (VRET).

HMD-VR can enhance occupational therapy by creating realistic environments that help clients confront anxiety triggers, potentially improving therapeutic outcomes through immersive experiences that simulate real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for the Treatment of Anxiety Disorders: A Scoping Review. Donnelly, MR., Reinberg, R., Ito, KL., et al.[2022]

Exposure therapy is highly effective for treating anxiety disorders but is underutilized, highlighting the need for increased awareness and use among therapists and patients.

Virtual reality exposure therapy (VRET) can enhance the accessibility and effectiveness of exposure therapy by providing controlled, immersive experiences that are often more acceptable to patients than traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Virtual Reality Exposure Therapy to Enhance Treatment of Anxiety Disorders: Identifying Areas of Clinical Adoption and Potential Obstacles. Boeldt, D., McMahon, E., McFaul, M., et al.[2023]

Virtual reality exposure therapy (VRET) significantly outperforms waitlist controls in treating anxiety disorders, indicating its effectiveness as an intervention.

When compared to traditional evidence-based treatments, VRET shows similar efficacy and stability of results over time, suggesting it can be a viable alternative or complement to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. Opriş, D., Pintea, S., García-Palacios, A., et al.[2012]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

Virtual reality exposure therapy for anxiety disorders is shown to be safe and effective, often matching the efficacy of traditional in-person exposure therapy.

The increasing availability of affordable virtual reality systems and the development of self-guided programs could significantly enhance access to treatment for anxiety disorders, potentially addressing mental health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Anderson, PL., Molloy, A.[2021]

Virtual reality (VR) biofeedback significantly reduces self-reported anxiety and heart rate in individuals, based on a systematic review of 7 studies involving 191 participants, including 5 randomized controlled trials.

While VR biofeedback showed promise in lowering anxiety and heart rate compared to waiting list controls, it did not demonstrate significant differences in outcomes when compared to traditional 2D biofeedback, indicating the need for further research in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. Kothgassner, OD., Goreis, A., Bauda, I., et al.[2022]

Virtual Reality Exposure Therapy (VRET) shows promising effectiveness for treating anxiety disorders, PTSD, and phobias, comparable to traditional in-person exposure therapies, based on various studies.

VRET offers advantages such as easier access to therapy, enhanced patient anonymity, and greater therapist control over exposure scenarios, although further research is needed to address existing limitations in the current studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality exposure therapy for post-traumatic stress disorders, obsessive-compulsive disorders and anxiety disorders: Indications, added value and limitations]. Lognoul, M., Nasello, J., Triffaux, JM.[2021]

In a pilot study involving 18 patients with acrophobia, virtual reality exposure therapy (VRET) was linked to significant changes in brain metabolism, particularly increased activity in the left frontal and precentral gyri after treatment.

The study found that these metabolic changes were associated with improved clinical outcomes, suggesting that VRET may enhance the visual-motor control system's role in treating acrophobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain metabolism and related connectivity in patients with acrophobia treated by virtual reality therapy: an 18F-FDG PET pilot study sensitized by virtual exposure. Verger, A., Malbos, E., Reynaud, E., et al.[2020]

The study employs a randomized controlled trial design with 45 patients divided into three groups to evaluate the efficacy of virtual reality (VR) in treating Generalized Anxiety Disorders, focusing on emotional regulation and relaxation.

Patients in the VR group use biofeedback to monitor their physiological responses in real-time, which may enhance their ability to manage anxiety symptoms compared to the non-VR and waiting list groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of biofeedback in clinical virtual reality: the intrepid project. Repetto, C., Gorini, A., Algeri, D., et al.[2018]

An automated virtual reality (VR) treatment for fear of heights significantly reduced fear levels in participants compared to usual care, with a large effect size (Cohen's d=2.0) after just two weeks of treatment.

The VR intervention was safe, with no reported adverse events, and the benefits were maintained at a four-week follow-up, suggesting that VR could be a valuable tool for addressing mental health disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated psychological therapy using immersive virtual reality for treatment of fear of heights: a single-blind, parallel-group, randomised controlled trial. Freeman, D., Haselton, P., Freeman, J., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

The use of virtual reality in assessment and treatment of anxiety and related disorders. [2021]

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

The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. [2022]

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

Virtual Reality for the Treatment of Anxiety Disorders: A Scoping Review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Using Virtual Reality Exposure Therapy to Enhance Treatment of Anxiety Disorders: Identifying Areas of Clinical Adoption and Potential Obstacles. [2023]

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

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. [2012]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]

9. Austria pubmed.ncbi.nlm.nih.gov

Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Virtual reality exposure therapy for post-traumatic stress disorders, obsessive-compulsive disorders and anxiety disorders: Indications, added value and limitations]. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Brain metabolism and related connectivity in patients with acrophobia treated by virtual reality therapy: an 18F-FDG PET pilot study sensitized by virtual exposure. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The use of biofeedback in clinical virtual reality: the intrepid project. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Automated psychological therapy using immersive virtual reality for treatment of fear of heights: a single-blind, parallel-group, randomised controlled trial. [2022]