What side effects are associated with this type of intervention?

Common treatments for PTSD include exposure therapy, cognitive-behavioral therapy (CBT), and pharmacological treatments like SSRIs and SNRIs. Exposure therapy, including Virtual Reality Exposure Therapy (VRET), can cause temporary increases in anxiety and distress as patients confront traumatic memories. CBT may also lead to emotional discomfort as patients work through challenging thoughts and behaviors. SSRIs and SNRIs, commonly used medications, can have side effects such as nausea, insomnia, sexual dysfunction, and increased risk of suicidal thoughts, particularly in young adults. VRET specifically may cause motion sickness or cybersickness due to the virtual reality environment.

What prior FDA approvals exist?

The FDA has approved several treatments for PTSD, including medications like selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. Additionally, there has been significant research into innovative therapies like MDMA-assisted psychotherapy, which has shown promise in clinical trials. Virtual Reality Exposure Therapy (VRET) is another emerging treatment, leveraging controlled virtual environments to help patients revisit and overcome traumatic experiences. While VRET itself may not yet have specific FDA approval, it builds on the well-established principles of exposure therapy, which is a validated and widely used approach for treating PTSD.

What other types of research exist?

Promising, novel alternatives to Virtual Reality Exposure Therapy for PTSD patients include: 1) MDMA-assisted therapy, which has shown efficacy in reducing PTSD symptoms in a randomized, double-blind, placebo-controlled phase 3 study. 2) Stellate Ganglion Block (SGB), which has demonstrated symptom reduction in randomized clinical trials. 3) Psilocybin-assisted psychotherapy, which has shown potential in treating psychiatric and existential distress in patients with life-threatening conditions. 4) Combined pharmacotherapy and psychological therapies, such as the combination of prolonged exposure therapy and paroxetine, which have been evaluated in randomized controlled trials.

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Behavioral Intervention

Virtual Reality Therapy for PTSD After COVID-19

Q: What is the mechanism of action of this treatment?

The most common treatments for Post-Traumatic Stress Disorder (PTSD) include trauma-focused cognitive behavioral therapy (CBT), exposure therapy, and pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs). Trauma-focused CBT helps patients process and reframe their traumatic experiences, reducing the emotional impact. Exposure therapy, including Virtual Reality Exposure Therapy (VRET), involves controlled exposure to trauma-related cues in a safe environment, allowing patients to confront and gradually desensitize their fears. VRET enhances this process by creating immersive, controllable scenarios that increase emotional engagement and acceptance. SSRIs help manage symptoms by balancing neurotransmitters in the brain. These treatments are crucial as they help patients reduce PTSD symptoms, improve coping mechanisms, and enhance overall quality of life.

Phase < 1

Recruiting

Led By JoAnn Difede, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

A COVID-19 patient or any healthcare worker providing medical care or support for COVID-19 patients

Age ≥18

Must not have

Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a virtual reality therapy to help healthcare workers and COVID-19 patients with PTSD. The therapy uses computer-generated environments to help them face and reduce the impact of their traumatic memories. Participants will have multiple sessions over several weeks to see if this approach is effective and tolerable. Virtual reality therapy (VRT) is a new psychotherapeutic approach integrating virtual reality technology and psychotherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort due to virtual reality such as dizziness or nausea (similar to motion sickness), temporary increase in stress levels during exposure therapy sessions, and rare risk of seizures if predisposed.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am 18 years old or older.

Select...

I have been diagnosed with PTSD.

Select...

I can understand and agree to the study's requirements.

Exclusion Criteria

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to approximately five weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to approximately five weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to approximately five weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability Indicator: Satisfaction

Change in Clinician Administered PTSD Score (CAPS-V)

Feasibility Indicator: Enrollment

+2 more

Secondary study objectives

Anxiety

Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology

Change in Score on the Occupational Stress Inventory Revised (OSI-R)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Virtual Reality Exposure TherapyExperimental Treatment1 Intervention

Virtual Reality Exposure Therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality Exposure Therapy

2006

Completed Phase 3

~610

0 / 5Eligibility 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

The most common treatments for Post-Traumatic Stress Disorder (PTSD) include trauma-focused cognitive behavioral therapy (CBT), exposure therapy, and pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs). Trauma-focused CBT helps patients process and reframe their traumatic experiences, reducing the emotional impact. Exposure therapy, including Virtual Reality Exposure Therapy (VRET), involves controlled exposure to trauma-related cues in a safe environment, allowing patients to confront and gradually desensitize their fears. VRET enhances this process by creating immersive, controllable scenarios that increase emotional engagement and acceptance. SSRIs help manage symptoms by balancing neurotransmitters in the brain. These treatments are crucial as they help patients reduce PTSD symptoms, improve coping mechanisms, and enhance overall quality of life.

Virtual reality in psychiatric disorders: A systematic review of reviews.Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability.Simulation and virtual reality in medical education and therapy: a protocol.