N/A
Completed N=162
Comparing Virtual Reality Exposure Therapy to Prolonged Exposure
Source: ClinicalTrials.gov NCT01459705 ↗Enrolled (actual)
162
Serious AEs
1.8%
Results posted
Dec 2015
Primary outcomePrimary: Clinician-Administered PTSD Scale (CAPS) — 78.28; 80.44; 78.89 units on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
38.33; 54.47 | — |
| SECONDARY PTSD Checklist- Civilian (PCL-C) |
— | — |
| SECONDARY Primary Care PTSD Screen (PC-PTSD) |
— | — |
| SECONDARY Beck Depression Inventory-II (BDI-II) |
— | — |
| SECONDARY Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) |
— | — |
| SECONDARY Perceived Stigma Measure (PSS) |
— | — |
| SECONDARY Suicide Risk Assessment |
— | — |
| SECONDARY Beck Anxiety Inventory (BAI) |
— | — |
| SECONDARY Behavior and Sympton Identification Scale (BASIS-24) |
— | — |
| SECONDARY Intent to Attend |
— | — |
| SECONDARY Subjective Units of Distress (SUDs) |
— | — |
| SECONDARY Side Effects Questionnaire |
— | — |
| SECONDARY BASIS-24 |
— | — |
| SECONDARY PTSD Checklist (PCL-C) |
— | — |
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
- history of loss of consciousness since entering active duty service greater than 15 minutes history of schizophrenia, other psychotic or bipolar disorder
Data sourced from ClinicalTrials.gov (NCT01459705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.