Virtual Therapy for PTSD

Recruiting in Palo Alto (17 mi)

Overseen by Sarah Jackson, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Suicidal ideation, Psychotic disorder, Bipolar, Severe substance abuse, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently undergoing another form of treatment more than twice a month or engaged in active trauma-focused therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment SIT NAVIGATOR for PTSD?

Research shows that Stress Inoculation Training (SIT), a part of SIT NAVIGATOR, has potential as a treatment for PTSD, especially among veterans. Additionally, virtual reality exposure therapy, which is similar to SIT NAVIGATOR, has shown promise in reducing PTSD symptoms by helping patients confront and process their traumatic experiences in a controlled environment. ^{1 2 3 4 5}

Is virtual therapy for PTSD safe for humans?

Research indicates that virtual reality exposure therapy (VRE) and stress inoculation training (SIT) can be safely delivered to individuals with PTSD, including those with military sexual trauma. These therapies have shown significant reductions in PTSD and depressive symptoms without reported safety concerns. ^{2 6 7 8 9}

How is the SIT NAVIGATOR treatment for PTSD different from other treatments?

SIT NAVIGATOR is unique because it uses virtual reality (VR) to provide stress inoculation training, which helps patients build resilience by simulating stressful situations in a controlled environment. This approach is different from traditional therapies as it combines VR technology with cognitive-behavioral techniques to enhance emotional coping skills and stress resilience. ^{1 4 10 11 12}

Research Team

Sarah Jackson, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals with Traumatic Brain Injury (TBI) and related stress disorders, including PTSD. Participants should be interested in a self-paced virtual therapy program to help manage their symptoms.

Inclusion Criteria

History of combat trauma and/or military service in an imminent danger pay area

Be fluent in English

I have been diagnosed with PTSD with a PCL-5 score over 33.

Exclusion Criteria

Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data

Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator

Active severe substance abuse as assessed by the investigator in accordance with DSM-5 Substance Abuse Disorder criteria, an AUDIT score > 15, or partial Brief Addiction Monitor (BAM) indicating the presence of illicit substance use other than cannabis (< 3 times weekly)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stress Inoculation Training (SIT) via a virtual platform, with or without a mobile health application, to reduce PTSD symptoms and improve resiliency.

11-14 weeks

Self-paced, virtual

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of PTSD symptoms, resiliency, and satisfaction with care.

4 weeks

Treatment Details

Interventions

• SIT NAVIGATOR (Behavioral Intervention)

Trial Overview The study tests the effectiveness of a Stress Inoculation Training (SIT) delivered virtually through a platform and an accompanying mobile app called Stress NAVIGATOR. It aims to see if these tools can reduce PTSD symptoms and increase resilience.

Participant Groups

Group I: SIT NAVIGATOR plus Stress NAVIGATOR group Experimental Treatment 2 Interventions

Group II: SIT NAVIGATOR only group Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Texas Health Science Center at Houston Houston, TX

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Patients Recruited

361,000+

Findings from Research

Virtual Vietnam is a novel therapeutic tool designed to help veterans with combat-related PTSD by providing immersive virtual environments that may facilitate exposure therapy.

This approach aims to address the challenges some patients face in visualizing or describing their traumatic experiences, potentially improving treatment outcomes for those who do not benefit from traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A virtual environment for the treatment of chronic combat-related post-traumatic stress disorder. Hodges, LF., Rothbaum, BO., Alarcon, R., et al.[2009]

The updated 'Virtual Iraq/Afghanistan' Virtual Reality system for exposure therapy (VRET) is designed to help service members and veterans at risk for PTSD, incorporating the latest technology for better treatment outcomes.

The system now includes expanded content to support therapy for combat medics and individuals who have experienced military sexual trauma, allowing for more personalized and relevant therapeutic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expansion of a VR Exposure Therapy System for Combat-Related PTSD to Medics/Corpsman and Persons Following Military Sexual Trauma. Rizzo, A., Hartholt, A., Rothbaum, B., et al.[2018]

A pilot study involving 44 patients with PTSD compared a computer-based trauma intervention using virtual reality (3MR) to standard treatment (TAU) and found that both methods led to similar reductions in PTSD and depression symptoms, suggesting that 3MR could be a viable alternative.

Despite the promising results, the study noted a high drop-out rate (45%) in the 3MR group and a small sample size, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to pilot the efficacy of a computer-based intervention with elements of virtual reality and limited therapist assistance for the treatment of post-traumatic stress disorder. van Meggelen, M., Morina, N., van der Heiden, C., et al.[2022]

A study involving 38 military veterans, both with and without PTSD, demonstrated that virtual environments (VEs) can effectively evoke physiological and emotional responses, particularly in those with PTSD, as indicated by significant changes in heart rate and discomfort levels when exposed to specific stimuli.

The research suggests that VEs, including scenarios like crowded auditoriums and startle sounds, can be valuable tools for helping veterans rehearse and manage their responses to potentially stressful situations, highlighting the need for further exploration of these environments in PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Rehearsal in a Simulated Environment. Clouse, C., Ewer, MW., French, D., et al.[2021]

References

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

A virtual environment for the treatment of chronic combat-related post-traumatic stress disorder. [2009]

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

Stress inoculation training outcomes among veterans with PTSD and TBI. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

STRIVE: Stress Resilience In Virtual Environments: a pre-deployment VR system for training emotional coping skills and assessing chronic and acute stress responses. [2015]

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

BusWorld: an analog pilot test of a virtual environment designed to treat posttraumatic stress disorder originating from a terrorist suicide bomb attack. [2008]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Expansion of a VR Exposure Therapy System for Combat-Related PTSD to Medics/Corpsman and Persons Following Military Sexual Trauma. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness evaluation for short-term group pre-deployment VR computer-assisted stress inoculation training provided to Polish ISAF soldiers. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

You can do that?!: Feasibility of virtual reality exposure therapy in the treatment of PTSD due to military sexual trauma. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of traumatized victims of war and torture: a randomized controlled comparison of narrative exposure therapy and stress inoculation training. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to pilot the efficacy of a computer-based intervention with elements of virtual reality and limited therapist assistance for the treatment of post-traumatic stress disorder. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing Clinical Training for the Treatment of PTSD Using Virtual Patients. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Immersive Rehearsal in a Simulated Environment. [2021]