Virtual Therapy for PTSD

Overseen By Sarah Jackson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

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

Duration: 11-14 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a virtual therapy tool called SIT NAVIGATOR, designed to help people with PTSD (post-traumatic stress disorder). The researchers aim to determine if this self-paced, online approach can reduce PTSD symptoms and boost resilience. Participants will use either the SIT NAVIGATOR alone or in combination with another tool called Stress NAVIGATOR. The trial seeks U.S. military veterans or service members with PTSD from combat or service in dangerous areas, who have access to a smartphone or tablet, and are fluent in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative PTSD treatment research.

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 prior data suggests that this virtual therapy is safe for PTSD treatment?

Research has shown that Stress Inoculation Training (SIT) is generally safe for people with PTSD. One study found that SIT reduced PTSD and depression symptoms without major safety concerns. Another study on delivering SIT virtually reported no negative side effects, indicating it is well-tolerated.

For the SIT NAVIGATOR plus Stress NAVIGATOR group, research on virtual therapies for PTSD showed significant reductions in PTSD symptoms without new safety issues. This indicates the treatment was generally safe and well-tolerated by participants.

Overall, both treatments appear safe, with no major negative effects reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Therapy for PTSD trial because it explores innovative digital methods for treating PTSD symptoms. Unlike traditional therapies like cognitive behavioral therapy (CBT) or medication such as SSRIs, the SIT NAVIGATOR and Stress NAVIGATOR utilize virtual platforms to deliver therapy. This approach offers the potential for greater accessibility and convenience, allowing patients to engage in therapy from their homes. Additionally, these digital tools could offer personalized, real-time feedback and support, which might enhance engagement and effectiveness compared to conventional therapy methods.

What evidence suggests that SIT NAVIGATOR could be an effective treatment for PTSD?

Studies have shown that Stress Inoculation Training (SIT) can reduce PTSD symptoms and improve mental health by teaching skills to manage stress and PTSD symptoms. Research indicates that SIT helps with both PTSD and related depression symptoms. In this trial, one group of participants will receive the SIT NAVIGATOR, an online version of SIT that has shown similar positive results. Another group will receive the SIT NAVIGATOR combined with the Stress NAVIGATOR, which may offer additional support. These findings suggest that these treatments could effectively help people with PTSD manage their symptoms better. ^{1 2 3 5 6}

Who Is on the Research Team?

Sarah Jackson, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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

Be fluent in English

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

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SIT NAVIGATOR

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.

How Is the Trial Designed?

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

Group II: SIT NAVIGATOR only group Active Control 1 Intervention

SIT NAVIGATOR is already approved in United States for the following indications:

Approved in United States as Stress Inoculation Training for:

• Post-Traumatic Stress Disorder (PTSD)
• Stress Management

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

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]

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]

A feasibility study involving 15 veterans with MST-related PTSD showed that virtual reality exposure therapy (VRE) significantly reduced PTSD and depressive symptoms after treatment, with improvements maintained at a 3-month follow-up.

The therapy was associated with large effect sizes and a decrease in the percentage of participants meeting PTSD criteria, indicating that VRE is a safe and promising treatment option for this population.

NCBI (Pubmed)

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. Loucks, L., Yasinski, C., Norrholm, SD., et al.[2020]

A pilot project is exploring the use of virtual patient systems to train clinicians in exposure therapy for treating PTSD, addressing the shortage of qualified personnel in the military.

Preliminary results suggest that immersive simulations with virtual patients can enhance the training of health providers, potentially improving the effectiveness of PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Clinical Training for the Treatment of PTSD Using Virtual Patients. Kenny, PG., Parsons, TD., Rothbaum, B., et al.[2022]

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]

Prolonged Exposure (PE) therapy is a highly effective treatment for PTSD, and this study introduces a new technology that allows therapists to guide patients through in vivo exposures (IVEs) in real-time, enhancing the treatment process.

The study involves a pilot randomized clinical trial with 40 veterans to assess the feasibility and preliminary efficacy of this innovative system, which collects physiological and self-report data to optimize exposure therapy and potentially improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. Back, SE., Acierno, R., Saraiya, TC., et al.[2023]

Virtual reality exposure (VRE) therapy can significantly reduce PTSD symptoms by immersing patients in computer-generated environments that replicate traumatic events, allowing them to confront and process their memories.

In a study with 30 volunteers, different levels of distress in a virtual simulation of a terrorist bus bombing were shown to elicit varying emotional responses, indicating that sound may enhance the effectiveness of VRE therapy for PTSD.

NCBI (Pubmed)

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. Josman, N., Reisberg, A., Weiss, PL., et al.[2008]

The STRIVE project is developing a Virtual Reality (VR) training program aimed at enhancing stress resilience in military personnel before deployment, building on positive initial outcomes from VR exposure therapy for PTSD.

This innovative approach includes immersive combat simulations and physiological monitoring to investigate stress responses, potentially providing effective coping strategies for emotional challenges faced in combat situations.

NCBI (Pubmed)

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. Rizzo, A., Buckwalter, JG., John, B., et al.[2015]

In a randomized controlled trial involving 28 PTSD patients, narrative exposure therapy (NET) significantly reduced PTSD severity over time, with effect sizes of 1.42 at 6 months and 1.59 at 1 year, while stress inoculation training (SIT) showed minimal effect.

The study highlights that NET is effective for treating PTSD symptoms in severely traumatized individuals, such as refugees and asylum seekers, suggesting its potential as a valuable therapeutic option in this population.

NCBI (Pubmed)

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. Hensel-Dittmann, D., Schauer, M., Ruf, M., et al.[2022]

A novel 3-phase group formulation of stress inoculation training (SIT) for veterans with PTSD and traumatic brain injury showed significant reductions in PTSD and depression symptoms, with effect sizes of 0.66 and 0.67, respectively, based on a study of 65 veterans over 18 months.

The SIT program also improved perceived stress tolerance and functioning in various life domains, with 88% of participants continuing to recommended follow-up treatments, indicating its potential to enhance treatment engagement among veterans reluctant to seek traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress inoculation training outcomes among veterans with PTSD and TBI. Jackson, S., Baity, MR., Bobb, K., et al.[2020]

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]

The short collective stress inoculation training (SIT) showed immediate effectiveness in reducing tension, indicating it can be a useful short-term intervention for stress management.

Long-term effectiveness of the training remains unclear, highlighting the need for further research to understand its lasting impact and the influence of individual temperamental factors on training outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness evaluation for short-term group pre-deployment VR computer-assisted stress inoculation training provided to Polish ISAF soldiers. Ilnicki, S., Wiederhold, BK., Maciolek, J., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30896224/

Stress inoculation training outcomes among veterans with ... The results of this study provide preliminary support for the use of this SIT protocol in reducing symptoms of PTSD and depression, improving performance, ...

2. ptsd.va.gov ptsd.va.gov/understand_tx/stress_inoculation_training.asp

Stress Inoculation Training (SIT) for PTSD Stress Inoculation Training (SIT) teaches coping skills to help you find new ways to manage PTSD symptoms or other stress in your life.

3. researchgate.net researchgate.net/publication/321663162_Effect_of_Stress_Inoculation_Training_With_Relaxation_Breathing_on_Perceived_Stress_and_Posttraumatic_Stress_Disorder_in_the_Military_A_Longitudinal_Study

(PDF) Effect of Stress Inoculation Training With Relaxation ... This study extends the investigation of the effectiveness of a SIT program of relaxation breathing on perceived stress symptoms and other mental health outcomes

4. psycnet.apa.org psycnet.apa.org/record/2019-14209-001

Stress inoculation training outcomes among veterans with ... Stress inoculation training (SIT) is a cognitive-behavioral treatment that has demonstrated potential as a nontrauma based intervention for veterans with ...

5. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-4-2024-a3b36?condition=Traumatic+Brain+Injury&overallStatus=Recruiting&hasNoPlacebo=false

Virtual Therapy for PTSD A novel 3-phase group formulation of stress inoculation training (SIT) for veterans with PTSD and traumatic brain injury showed significant reductions in PTSD ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0740547298000671

Substance Dependence Posttraumatic Stress Disorder ... Overall, exposure-based PTSD treatments appear to be effective on a sustained basis in decreasing PTSD severity, although, to date, these approaches have not ...