Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders
- Sponsor
- National Center for Telehealth and Technology
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Clinician-Administered PTSD Scale (CAPS)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is evaluating the efficacy of virtual reality 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 hypothesis 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 Operation Iraqi Freedom/ Operation Enduring Freedom(OIF/OEF)
- •non sexually based deployment related trauma
- •three or more months since index trauma
- •stable on psychotropic medication 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.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.
Secondary Outcomes
- Suicide Risk Assessment(26 Week follow up)
- Perceived Stigma Measure (PSS)(26 week follow up)
- Beck Anxiety Inventory (BAI)(26 week follow up)
- Side Effects Questionnaire(Treatment session 10 (week 5))
- BASIS-24(26 week follow up)
- Subjective Units of Distress (SUDs)(Treatment session 10 (week 5))
- PTSD Checklist (PCL-C)(26 week follow up)
- Primary Care PTSD Screen (PC-PTSD)(26 Week follow up)
- Beck Depression Inventory-II (BDI-II)(26 Week follow up)
- Intent to Attend(2.5 weeks (or after treatment session 5))
- PTSD Checklist- Civilian (PCL-C)(Screening Visit (Day 1))
- Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)(26 Week follow up)
- Behavior and Sympton Identification Scale (BASIS-24)(Screening Visit(Day 1))