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Behavioral Intervention
Virtual Reality Therapy for PTSD After COVID-19
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
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 belowSelect...
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
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 moreSecondary 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 moreTrial 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
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.
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.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,079 Previous Clinical Trials
1,137,883 Total Patients Enrolled
Cornell UniversityOTHER
170 Previous Clinical Trials
14,091,098 Total Patients Enrolled
JoAnn Difede, PhDPrincipal InvestigatorWeill Medical College of Cornell University
5 Previous Clinical Trials
444 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are considered to be at risk of hurting yourself or others by the person in charge of the study.I am a COVID-19 patient or a healthcare worker caring for COVID-19 patients.I am 18 years old or older.My health condition is currently stable.I have been in a mental health study or treated for psychiatric conditions or PTSD in the last 3 months.I have been diagnosed with PTSD.I have been on the same mental health medication for the last 60 days.I can understand and agree to the study's requirements.You have a history of getting sick from motion or having seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality Exposure Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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