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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the brain creates feelings of fear and anxiety, particularly in individuals with disorders like PTSD and generalized anxiety disorder. Researchers will monitor participants' brain activity, heart rate, and skin sweat levels during computer-based tasks (also known as computer-assisted therapy) and while using a virtual reality headset in a video game-like setting. The tasks will display various fear-provoking images to understand the brain's reactions. Individuals who have undergone specific brain procedures (acute depth or chronic responsive neurostimulation) and can read and write English are well-suited for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on fear and anxiety.

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 prior data suggests that these computer-based and virtual reality tasks are safe for participants?

Research has shown that both computer-based activities and virtual reality (VR) exercises are safe and effective for treating anxiety disorders. Studies have found that online cognitive behavioral therapy and virtual reality exposure therapy work as well as traditional methods. These approaches reduce social anxiety and specific fears without major side effects.

Virtual reality treatments, in particular, receive positive feedback. They have demonstrated significant effects in lowering anxiety symptoms. People using VR often notice improvements in their anxiety, and these improvements usually persist after treatment ends.

Overall, both computer-based and VR activities have a strong record of safety and effectiveness in anxiety treatment, making them promising options for managing anxiety disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using computer-based and virtual reality tasks for managing anxiety because these innovative methods offer a fresh approach compared to traditional treatments like medication and talk therapy. Unlike standard options that often rely on altering brain chemistry with drugs, these tasks focus on directly engaging and modifying brain activity through interactive experiences. This approach not only provides a non-invasive alternative but also has the potential to offer immediate feedback and customization, making the treatment more precise and personalized for each individual.

What evidence suggests that these computer-based and virtual reality tasks could be effective for anxiety?

Research has shown that computer-based and virtual reality activities can help reduce anxiety. In this trial, participants will engage in either computer-based tasks or virtual reality tasks. Virtual reality therapy, in particular, has effectively improved anxiety. Studies have found that virtual reality exposure therapy can work as well as facing real-life situations for treating anxiety and phobias. Additionally, computer-based activities using virtual reality cognitive behavioral therapy have shown specific benefits for anxiety and depression. This evidence suggests that participating in these interactive activities may help manage anxiety disorders like PTSD and GAD. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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+

Published Research Related to This Trial

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]

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]

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 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) 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]

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]

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]

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]

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 (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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8342859/

Virtual Reality-Assisted Cognitive Behavioral Therapy for ... Conclusion: VRCBT treatment has a specific positive effect on patients with anxiety disorders (anxiety and depression). Compared with standard ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725006755

Effectiveness of internet-based cognitive behavioral ... This study examines the effectiveness of a 14-week iCBT program that includes VRET, called “Ease Anxiety in Social Event Online” (Ease Online), among Hong Kong ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11047275/

Cognitive behavioural therapy in virtual reality treatments ... The aim of this systematic review is to investigateCBT treatment methods that utilize VR to treat mental health disorders.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0005791623000605

Impact of virtual reality applications in the treatment ... The objective is to evaluate the treatment effect of virtual reality applications in the treatment of anxiety disorders compared to conventional therapy.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0315313

A systematic review and meta-analysis protocol | PLOS One The effectiveness of virtual reality exposure–based cognitive behavioral therapy for severe anxiety disorders, obsessive-compulsive disorder, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10540030/

Internet-Based Cognitive Behavioral Therapy and Virtual ... One of the most effective treatments for SAD is cognitive behavioral therapy (CBT), with internet-based CBT (iCBT) and virtual reality exposure therapy (VRET) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5421394/

The use of virtual reality technology in the treatment ... This review will provide an overview of the history of the development of VR based technology and its use within psychiatric treatment, an ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1386505625001194

Review article Self-guided virtual reality therapy for anxiety Self-guided VR interventions for anxiety can provide an effective treatment of social anxiety disorder, public speaking anxiety, and specific phobias.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03973541

CBT With VR Based Exposure for Social Anxiety Disorder EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - A Randomized Controlled Superiority Trial Comparing Cognitive Behavioral Therapy With Virtual Reality ...

10. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2025.1588181/full

Virtual reality-based exposure with 360° video as part of ... Cognitive behavioral therapy (CBT) is effective in treating SAD, but real-life exposure conducted as part of CBT is often costly and time- ...