Virtual Reality Therapy for PTSD After COVID-19

Overseen By JoAnn Difede, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Weill Medical College of Cornell University

Must be taking: Psychotropic medications

Disqualifiers: Schizophrenia, Psychotic disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 5 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy using virtual reality to help individuals with PTSD (post-traumatic stress disorder) manage their trauma. The focus is on healthcare workers and COVID-19 patients who have experienced pandemic-related distress. Participants will use virtual reality in therapy sessions to revisit and overcome traumatic experiences. This trial suits English-speaking COVID-19 patients or healthcare workers with PTSD or its symptoms who are medically stable. As an Early Phase 1 trial, participants will be among the first to experience this innovative therapy, aiding researchers in understanding its effects on PTSD.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their psychotropic medication for the prior 60 days, so you will not need to stop taking your current medications if they have been stable.

What prior data suggests that this virtual reality therapy is safe for treating PTSD?

Research has shown that virtual reality exposure therapy (VRET) is generally safe for treating PTSD. Studies have found that VRET is as safe as other common therapies. One review compared VRET to a group that did not receive immediate treatment and found no increase in negative effects.

Another study found that VRET, when combined with monitoring of physical responses, was effective without major safety concerns. Participants in these studies handled the therapy well and reported few negative effects.

These findings indicate that VRET is usually well-tolerated and considered safe for people with PTSD. Participants in these studies did not report major side effects, making VRET a promising option for PTSD treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Virtual Reality Exposure Therapy is unique because it leverages immersive technology to address PTSD symptoms that arose after COVID-19. Unlike traditional treatments like talk therapy or medication, which can take longer to see results, this therapy provides a controlled and interactive environment where patients can confront and process traumatic experiences more directly. Researchers are excited about this approach because it offers a new, engaging way to potentially accelerate healing by providing personalized and immediate feedback in a safe setting.

What evidence suggests that Virtual Reality Exposure Therapy is effective for PTSD?

Research has shown that Virtual Reality Exposure Therapy (VRET), which participants in this trial will receive, can greatly reduce PTSD symptoms. Studies have found it helps people cope with trauma by recreating traumatic experiences in a safe, virtual setting. This method has successfully treated military veterans and first responders. VRET has also been shown to help with stress, anxiety, and depression related to traumatic events, including those connected to COVID-19. The immersive experience of virtual reality enhances traditional exposure therapy, making it a promising treatment for PTSD. ^{6 7 8 9 10}

Who Is on the Research Team?

JoAnn Difede, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who have PTSD from COVID-19 as patients or healthcare workers. They must be medically stable, able to consent, and not have changed psychotropic meds in the last 60 days. It's not for those with unstable illnesses, current severe risks to themselves or others, a history of motion sickness or seizures, recent psychiatric treatment trials, or psychotic disorders.

Inclusion Criteria

I am a COVID-19 patient or a healthcare worker caring for COVID-19 patients.

My health condition is currently stable.

I have been diagnosed with PTSD.

Exclusion Criteria

You are considered to be at risk of hurting yourself or others by the person in charge of the study.

Current significant unstable medical illness such that the participant could not attend sessions regularly or complete assessments

I have been in a mental health study or treated for psychiatric conditions or PTSD in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete ten ninety-minute sessions of virtual reality exposure therapy, twice a week for five weeks, aimed at mitigating PTSD symptoms

5 weeks

10 sessions (in-person or remotely)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at three months post-treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Exposure Therapy

Trial Overview

The study tests Virtual Reality Exposure Therapy on healthcare workers and COVID-19 survivors with PTSD. Participants will undergo ten ninety-minute VR sessions over five weeks to help them process their traumatic experiences related to the pandemic.

How Is the Trial Designed?

Group I: Virtual Reality Exposure Therapy Experimental Treatment 1 Intervention

Virtual Reality Exposure Therapy

Virtual Reality Exposure Therapy is already approved in United States for the following indications:

Approved in United States as Virtual Reality Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Published Research Related to This Trial

Prolonged exposure (PE) therapy significantly reduces PTSD symptoms in active-duty soldiers, showing its efficacy in this population with 162 participants undergoing treatment and follow-ups.

While both PE and virtual reality exposure (VRE) therapies were effective compared to a waitlist group, PE demonstrated greater long-term symptom reduction at 3- and 6-month follow-ups, suggesting it may be the more effective option for treating PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of prolonged exposure using imaginal exposure vs. virtual reality exposure in active duty soldiers with deployment-related posttraumatic stress disorder (PTSD). Reger, GM., Koenen-Woods, P., Zetocha, K., et al.[2022]

A study involving 17 participants (9 in the VR treatment group and 8 in the waitlist control group) found that VR-enhanced exposure therapy significantly reduced PTSD symptoms after 14 sessions, with a large effect size of 1.53.

The results indicate that using virtual reality can effectively increase patient engagement and improve treatment outcomes for individuals suffering from PTSD, particularly those affected by the September 11 attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of virtual reality to the treatment of PTSD following the WTC attack. Difede, J., Cukor, J., Patt, I., et al.[2006]

The emergence of SARS-CoV-2 variants that can evade vaccine-induced immunity poses a significant threat to ongoing vaccination efforts and may extend the COVID-19 pandemic.

Among the 24 treatments reviewed for COVID-19, six have been shown to significantly reduce mortality in clinical trials, while ten others demonstrated some level of clinical efficacy, highlighting the importance of diverse therapeutic options in managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical drug therapies and biologicals currently used or in clinical trial to treat COVID-19. Malek, RJ., Bill, CA., Vines, CM.[2023]

Virtual reality exposure therapy (VRET) has been shown to be more effective than waitlist control groups in treating PTSD, with a significant effect size indicating its potential as a treatment option.

However, VRET's efficacy compared to other active treatments was not significantly different, highlighting the need for more high-quality studies to better understand its effectiveness and safety, especially since most existing studies had low quality and varied methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of immersive PTSD treatments: A systematic review of virtual and augmented reality exposure therapy and a meta-analysis of virtual reality exposure therapy. Eshuis, LV., van Gelderen, MJ., van Zuiden, M., et al.[2021]

Current evidence does not clearly support the use of pharmacotherapy for COVID-19, indicating that while some treatments show promise, they must be approached with caution due to potential risks and unclear benefits.

The review emphasizes the need for well-designed clinical trials to better understand the efficacy and safety of COVID-19 treatments, suggesting that therapies should primarily be used in research settings until more definitive evidence is available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The trade-off dilemma in pharmacotherapy of COVID-19: systematic review, meta-analysis, and implications. Khan, S., Gionfriddo, MR., Cortes-Penfield, N., et al.[2022]

Virtual Reality Exposure Therapy (VRET) has been shown to be an effective treatment for PTSD in service members who have served in Iraq or Afghanistan, supported by randomized controlled trials.

The study compares VRET to a control exposure therapy (CET) protocol, highlighting the potential benefits of VR in enhancing the effectiveness of traditional exposure therapy despite its higher costs and complexity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of Virtual Reality to Virtual Reality Exposure Therapy, Study Design of a Randomized Trial. McLay, RN., Baird, A., Murphy, J., et al.[2018]

The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has led to over 6.5 million cases and 380,000 deaths, particularly affecting the elderly, highlighting the urgent need for effective antiviral therapies and vaccines.

This review discusses promising emerging therapies and vaccines for COVID-19 and identifies potential viral targets for future research and drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccines and Therapies in Development for SARS-CoV-2 Infections. Wu, D., Koganti, R., Lambe, UP., et al.[2020]

Virtual reality exposure therapy (VRET) effectively reduced symptoms of anxiety and fear related to COVID-19 infection in three patients, demonstrating its potential as a treatment for phobias and anxiety disorders during the pandemic.

The therapy involved immersive virtual scenarios that allowed patients to confront their fears safely, providing a valuable alternative to in-person exposure therapy, especially in situations where direct exposure is risky.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Exposure Therapy (VRET) for Anxiety Due to Fear of COVID-19 Infection: A Case Series. Zhang, W., Paudel, D., Shi, R., et al.[2020]

Mesenchymal stem cells (MSCs) show promise in cellular therapy for treating severe COVID-19 by modifying the lung microenvironment and exerting immunomodulatory effects that can repair lung injury.

While cellular therapies are not yet approved for COVID-19 treatment, ongoing clinical trials aim to evaluate their efficacy and safety, highlighting their potential as a novel approach to combat severe respiratory complications associated with the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellular Therapy: Shafts of Light Emerging for COVID-19. Jeyaraman, M., Ranjan, R., Kumar, R., et al.[2020]

Emerging therapeutics for COVID-19 are being rapidly investigated, with two main categories showing promise: antiviral treatments that target the virus directly and therapies that address the inflammatory response caused by severe disease.

Preliminary evidence suggests that treatments like convalescent plasma therapy and lung radiation may be effective, but most current studies are small and the results are still evolving, highlighting the need for larger, well-designed trials to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review of Emerging Therapeutics for COVID-19. Willis, VC., Arriaga, Y., Weeraratne, D., et al.[2023]

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