What side effects are associated with this type of intervention?

Common treatments for Social Anxiety Disorder (SAD) include Virtual Reality Exposure Therapy (VRET) and pharmacotherapy. VRET, which involves exposure to virtual social scenarios, is generally well-tolerated with minimal side effects, mainly temporary discomfort or increased anxiety during sessions. Pharmacotherapy, often involving SSRIs or SNRIs, can have side effects such as nausea, headache, sleep disturbances, sexual dysfunction, and weight gain. Combining these treatments with cognitive-behavioral therapy (CBT) can enhance efficacy and help manage side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Social Anxiety Disorder (SAD), primarily focusing on pharmacotherapy and cognitive-behavioral therapy (CBT). Selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine are commonly prescribed and have shown efficacy in reducing social anxiety symptoms. Additionally, the FDA has permitted the marketing of digital therapeutics, such as game-based interventions, which aim to improve attention and reduce anxiety through interactive and engaging methods. These treatments share similarities with Virtual Reality Exposure Therapy (VRET), which uses virtual social scenarios to help individuals practice and reduce social anxiety in a controlled environment.

What other types of research exist?

Promising, novel alternatives to Virtual Reality Exposure Therapy for Social Anxiety Disorder patients include: 1) Psilocybin-assisted psychotherapy, which has shown potential in reducing psychiatric and existential distress; 2) MDMA-assisted psychotherapy, which is being explored for its efficacy in treating PTSD and may have applications for SAD; 3) Digital Cognitive Behavioral Therapy (CBT) platforms, which offer accessible and scalable treatment options; 4) Deep Brain Stimulation (DBS), which is being investigated for treatment-resistant cases of various psychiatric disorders, including OCD and potentially SAD.

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Virtual Reality Therapy for Social Anxiety Disorder

N/A

Recruiting

Led By Michelle G. Newman, Ph.D.

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently not receiving treatment from a mental health professional

Be older than 18 years old

Must not have

Below age 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6-month post-randomization

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort from wearing the VR headset, dizziness or nausea due to motion sickness from VR use, and possible temporary increase in anxiety symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not currently seeing a mental health professional.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6-month-post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6-month-post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-month-post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Job Interview Anxiety at 2-8-week-post-randomization

Change from Baseline Job Interview Anxiety at 3-month post-randomization

Change from Baseline Job Interview Anxiety at 6-month post-randomization

+3 more

Secondary study objectives

Change from Baseline Depression Symptom Severity at 2-8-week-post-randomization

Mental Depression

Change from Baseline Depression Symptom Severity at 6-month-post-randomization

+3 more

Other study objectives

Mental health disorder screening measures

Process measures

Treatment acceptability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual reality exposure therapyExperimental Treatment1 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 listActive Control1 Intervention

Participants started treatment 2-4 weeks post-randomization.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exposure therapy, including Virtual Reality Exposure Therapy (VRET), is a common treatment for Social Anxiety Disorder (SAD) that works by gradually exposing patients to feared social situations in a controlled environment. VRET uses virtual scenarios to simulate real-life social interactions, allowing patients to practice and build confidence in a safe, repeatable setting. This approach helps reduce anxiety symptoms, improve social skills, and increase overall functioning in social situations, making it a practical and effective treatment for SAD patients.

Exposure Therapy With Personalized Real-Time Arousal Detection and Feedback to Alleviate Social Anxiety Symptoms in an Analogue Adult Sample: Pilot Proof-of-Concept Randomized Controlled Trial.