Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With PTSD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post Traumatic
- Sponsor
- National Center for Telehealth and Technology
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Clinician-Administered PTSD Scale (CAPS)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study is evaluating the efficacy of virtual realty exposure therapy (VRET)by comparing it to prolonged exposure therapy (PE) and a waitlist (WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypotheses that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.
Detailed Description
The rationale for this study is based on growing evidence demonstrating that VRET is an efficacious treatment for PTSD and holds the potential to improve access to care for Soldiers who would otherwise avoid treatment. Although PE is considered one of the most effective cognitive-behavioral therapies (CBT) for treatments for PTSD, there are reasons why it may not be the most viable option for many Soldiers. First, Prolonged exposure requires a level of emotional engagement during exposure to the trauma that many patients are unable to obtain. Second, stigma and concerns about how Soldiers will be perceived by peers and leadership has a dramatic impact on whether a Soldier will seek care. VRET may address these concerns and may also improve treatment outcomes and access to care by augmenting the patient's re-living of the trauma with a sensory-rich environment and moderating stigma perceptions by offering non-traditional treatment that is a preferable option for many Soldiers who are reluctant to seek out traditional talk therapies. Despite its promise as a viable treatment option, few studies have examined VRET for combat-related PTSD and there are no published studies that have compared VRET to PE in the treatment of combat-related PTSD. Positive results may provide new treatment options for all Soldiers, but should prove to be an especially attractive option for Soldiers who either do not respond to, or are reluctant to engage in other established therapies such as PE.
Investigators
Eligibility Criteria
Inclusion Criteria
- •PTSD diagnosis as assessed by CAPS
- •history of deployment in support of OIF/OEF
- •non sexually based deployment related trauma
- •three or more months since index trauma
- •stable on psychotropic medications for 30 days
Exclusion Criteria
- •index trauma in the last three months
- •history of schizophrenia, other psychotic or bipolar disorder
- •history of organic brain disorder
- •suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months
- •ongoing threatening situation
- •current drug or alcohol dependence
- •history of seizures
- •prior history of PE for PTSD
- •other current psychotherapy
- •physical condition that interferes with proper use of Virtual Reality head mounted display
Outcomes
Primary Outcomes
Clinician-Administered PTSD Scale (CAPS)
Time Frame: 26 Week follow-up
The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.
Secondary Outcomes
- Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)(26 Week Follow-up)
- Primary Care PTSD Screen (PC-PTSD)(26 Week Follow-up)
- Perceived Stigma Measure (PSS)(26 Week Follow-up)
- BASIS-24(26 Week Follow-up)
- Beck Depression Inventory-II (BDI-II)(26 Week Follow-up)
- Beck Anxiety Inventory (BAI)(26 Week Follow-up)
- PTSD Checklist (PCL-C)(26 Week Follow-up)
- Suicide Risk Assessment(26 Week Follow-up)
- Subjective Units of Distress (SUDs)(Treatment session 10 (Week 5))
- Side Effects Questionnaire(Treatment session 10 (Week 5))