Stress Disorders, Post Traumatic
Conditions
Keywords
Combat Disorders, Exposure Therapy, Army Personnel
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.
Interventions
BEHAVIORALProlonged Exposure Therapy (PE)
Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
BEHAVIORALVirtual Reality Exposure Therapy (VRET)
Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
BEHAVIORALWaitlist
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Sponsors
University of Southern California
National Center for Telehealth and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * history of loss of consciousness since entering active duty service greater than 15 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | Screening Visit ( Day 1) | 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
| Measure | Time frame | Description |
|---|---|---|
| Primary Care PTSD Screen (PC-PTSD) | Screening Visit(Day 1) | The PC-PTSD is a four-item measure designed to screen for PTSD. |
| Beck Depression Inventory-II (BDI-II) | Screening Visit(Day 1) | This self report measure of depression contains 21 items that are rated on a 4 point scale. |
| Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) | Screening Visit(Day 1) | The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma. |
| Perceived Stigma Measure (PSS) | Screening Visit(Day 1) | Stigma will be measured using a 5 question assessment scale. |
| PTSD Checklist (PCL-C) | Screening Visit (Day 1) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. |
| Beck Anxiety Inventory (BAI) | Screening Visit(Day 1) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. |
| BASIS-24 | Screening Visit(Day 1) | To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature. |
| Subjective Units of Distress (SUDs) | Treatment session 1 (week 1) | Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation. |
| Side Effects Questionnaire | Treatment session 1(week 1) | The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study. |
| Suicide Risk Assessment | Screening Visit(Day 1) | Due to the nature of the questions, this is deemed to be of safety nature. |
Countries
United States
Outcome results
None listed