Virtual Reality Therapy for Social Anxiety Disorder

Overseen By Michelle G. Newman, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Suicidality, Mania, Psychosis, Substance use, others

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: 3

Duration: 2-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether virtual reality therapy can help people with social anxiety disorder (SAD) manage their symptoms. Participants will engage in virtual reality scenes that gradually become more challenging, simulating real-world social situations like job interviews or social gatherings. The goal is to determine if this therapy reduces anxiety and improves social interactions over the long term. This trial suits individuals who struggle with social situations, are not currently receiving mental health treatment, and can provide their consent. As an unphased trial, it offers a unique opportunity to explore innovative therapy methods for managing social anxiety.

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, since participants cannot be receiving treatment from a mental health professional, it might imply that you should not be on certain psychiatric medications.

What prior data suggests that these virtual reality exposure therapy scripts are safe for treating social anxiety disorder?

Research has shown that virtual reality exposure therapy (VRET) is generally safe for people with social anxiety disorder. Studies have found that VRET often leads to positive outcomes, such as reduced anxiety. VRET is not only effective but also manageable for most individuals. Most users find it safe and acceptable, with no major reports of harmful side effects. This suggests it is a promising and safe option for managing social anxiety symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Virtual Reality Exposure Therapy (VRET) is unique because it offers an immersive, interactive experience that traditional therapies like cognitive-behavioral therapy (CBT) don't provide. Researchers are excited about this treatment because it allows participants to face anxiety-inducing situations in a controlled, virtual environment, potentially making it easier for them to practice and improve their social skills without the pressure of real-world consequences. Additionally, the inclusion of a virtual therapist to guide and coach participants through each step is a novel feature, providing personalized feedback and support that could enhance the effectiveness of the therapy.

What evidence suggests that Virtual Reality Exposure Therapy is effective for social anxiety disorder?

Research shows that Virtual Reality Exposure Therapy (VRET), which participants in this trial may receive, can greatly reduce social anxiety symptoms. Studies have found that VRET outperforms doing nothing, as demonstrated in waitlist control groups, by lowering anxiety after treatment. Comparisons indicate that VRET and traditional exposure therapy are equally effective, both leading to moderate improvements in reducing social phobia and anxiety symptoms. Specifically, VRET has shown better results than in-person exposure therapy six months after treatment. Overall, these findings support VRET as a promising tool for managing social anxiety disorder. ^{2 3 6 7 8}

Who Is on the Research Team?

Michelle G. Newman, Ph.D.

Principal Investigator

The Pennsylvania State University

Are You a Good Fit for This Trial?

This trial is for adults proficient in English with social anxiety disorder who are not currently under mental health treatment. Participants must be either students at Pennsylvania State University or community-dwelling adults interested in the study, and willing to seek treatment.

Inclusion Criteria

I am not currently seeing a mental health professional.

Presence of Social Anxiety Disorder based on the Social Phobia Diagnostic Questionnaire self-report or Mini International Neuropsychiatric Interview

I am a Penn State student or a community member interested via the PSU StudyFinder.

Exclusion Criteria

Presence of suicidality, mania, psychosis, or substance use disorders

Failure to meet any of the above inclusion criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Virtual Reality Exposure Therapy (VRET) to treat social anxiety disorder symptoms

2-8 weeks

Multiple sessions with virtual therapist guidance

Follow-up

Participants are monitored for maintenance of treatment gains and symptom changes

6 months

Assessments at 3-month and 6-month post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Pico Goblin VR headset
• Virtual Reality Exposure Therapy Scripts

Trial Overview

The trial tests if virtual reality exposure therapy using Pico Goblin VR headsets can help people with social anxiety by simulating social interactions. It compares this method against a waitlist control group to see if it's effective immediately and maintains benefits after 3-6 months.

How Is the Trial Designed?

Group I: Virtual reality exposure therapy Experimental Treatment 1 Intervention

Participants were allowed to choose one of two themes. For both themes, each scene was developed to be more anxiety-provoking as the VRE progressed. Greater anxiety-inducing scenes had interviewers and other actors who displayed less compassionate, friendly, humorous, and pleasant verbal and non-verbal behaviors and demeanors to elicit elevated anxiety (Carless \& Imber, 2007). Also, a virtual therapist was embedded within the VRE. It functioned to coach the participant through each distinct scene by orienting and prompting them to the exposure therapy task(s), continually conveying core principles of exposure therapy, and repeating the instructions if the participant was not responsive within five seconds. Each scene started with a paused video, during which participants were oriented by the virtual therapist to the context.

Group II: Waiting list Active Control 1 Intervention

Participants started treatment 2-4 weeks post-randomization.

Virtual Reality Exposure Therapy Scripts is already approved in United States, European Union for the following indications:

Approved in United States as Virtual Reality Exposure Therapy for:

• Social Anxiety Disorder (SAD)

Approved in European Union as Virtual Reality Exposure Therapy for:

• Social Anxiety Disorder (SAD)

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Limbix Health, Inc.

Industry Sponsor

Trials

8

Recruited

730+

Published Research Related to This Trial

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) has been shown to significantly reduce symptoms of social anxiety disorder (SAD) across six studies, indicating its effectiveness as a treatment option.

Most studies had small sample sizes and limitations in ecological validity, suggesting that future research should involve larger clinical samples to better assess VRET's impact on a wider range of social behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Literature Review Examining Virtual Reality Exposure Therapy for Individuals Diagnosed With Social Anxiety Disorder. Arif, R., Ashraf, S., Bhatt, K., 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]

The MOTEK CAREN system, used in virtual reality exposure therapy, showed potential in reducing anxiety levels in a 45-year-old woman after four training sessions, indicating its promise for treating anxiety disorders.

Despite initial stress responses indicated by increased heart rate, blood pressure, and salivary cortisol, the patient demonstrated gradual adaptation with decreased cortisol and anxiety levels over the sessions, suggesting a positive therapeutic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the MOTEK CAREN system in behavioural therapy for patients with anxiety disorders. Krysta, K., Wilczyński, K., Paliga, J., 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]

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]

Social anxiety patients experience higher levels of anxiety in response to ambiguous virtual social feedback compared to healthy controls, suggesting they interpret such feedback more negatively.

The study highlights the importance of considering both the type and clarity of social feedback in virtual reality exposure therapy, as ambiguous feedback can exacerbate anxiety in social anxiety patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influences of virtual social feedback on social anxiety disorders. Kishimoto, T., Ding, X.[2022]

Virtual reality exposure therapy (VRET) is a promising alternative for treating social anxiety disorder (SAD), offering a cost-effective and flexible approach compared to traditional in vivo exposure therapy (iVET).

While VRET showed similar effectiveness to iVET in improving social skills and reducing SAD symptoms, its advantages include lower costs and the ability to create customized therapeutic experiences for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Simulation Game-Virtual Reality Therapy for the Treatment of Social Anxiety Disorder: A Systematic Review. Caponnetto, P., Triscari, S., Maglia, M., et al.[2021]

Citations

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Virtual reality exposure therapy for social anxiety disorders

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An early study showed that four therapist-facilitated 12-to-15-minute sessions of VRE (vs. WL) efficaciously reduced public speaking phobia for highly anxious ...

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Virtual reality exposure therapy for social anxiety disorders

Virtual reality exposure therapy has greater efficacy than waitlist comparators in reducing anxiety symptoms at post-intervention and follow-up assessment.

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These findings indicate that VRET can significantly reduce symptoms of social anxiety. Note, however, that uncontrolled effect sizes do not account for the ...

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clinicaltrials.gov/study/NCT04850989

Efficacy of Virtual Reality Exposure Therapy Scripts for ...

The purpose of this study is to test the efficacy virtual reality videos to facilitate exposure therapy in social anxiety disorder (SAD).