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

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if virtual reality videos can help people with social anxiety practice social situations. It targets those who struggle with social interactions and everyday tasks. The therapy works by letting them practice in a virtual world to make real-life interactions less scary. Virtual reality exposure therapy (VRET) has been used in recent years to treat various anxiety disorders, including social phobia.

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.

Is Virtual Reality Therapy safe for humans?

The research does not specifically address safety concerns, but Virtual Reality Exposure Therapy (VRET) is widely used and considered a valid alternative for treating social anxiety and phobias, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How is Virtual Reality Exposure Therapy different from other treatments for social anxiety disorder?

Virtual Reality Exposure Therapy (VRET) is unique because it uses computer-generated environments to simulate social situations, allowing patients to practice coping skills in a controlled, immersive setting. Unlike traditional in vivo exposure therapy, VRET can be more cost-effective and flexible, providing a tailored experience without the logistical challenges of real-world exposure. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Virtual Reality Therapy for Social Anxiety Disorder?

Research shows that Virtual Reality Exposure Therapy (VRET) is effective in reducing symptoms of Social Anxiety Disorder (SAD). Studies found significant improvements in social skills and anxiety symptoms, making VRET a promising alternative to traditional therapies due to its lower cost and flexibility. ^{1 4 5 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

I am under 18 years old.

Failure to meet any of the above inclusion criteria

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

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]

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 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) 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]

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]

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) 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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

The influences of virtual social feedback on social anxiety disorders. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Simulation Game-Virtual Reality Therapy for the Treatment of Social Anxiety Disorder: A Systematic Review. [2021]

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

A Literature Review Examining Virtual Reality Exposure Therapy for Individuals Diagnosed With Social Anxiety Disorder. [2023]

6. Croatia pubmed.ncbi.nlm.nih.gov

Implementation of the MOTEK CAREN system in behavioural therapy for patients with anxiety disorders. [2019]

7. 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]

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

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