NCT06740487 Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder
| NCT ID | NCT06740487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wayne State University |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-06-01 |
Trial Parameters
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Brief Summary
The goal of this trial is to test how augmented reality exposure therapy (ARET) may potentiate the effects of traditional exposure therapy administered to U.S. military personnel diagnosed with PTSD. 40 adult males and females over the age of 18 that have served, or are currently serving, in the U.S. military, with a current diagnosis of PTSD, will be recruited. Participants will be randomized into two groups: 20 participants will receive ARET + traditional ET, with the remaining 20 to receive traditional ET only. The main questions this trial aims to answer are: * what are the different clinical and psychosocial functioning outcomes between veterans/active-duty personnel with PTSD who receive ARET + traditional ET versus traditional ET only * what are the differences in acceptance and satisfaction of treatment, between ARET + traditional ET and the traditional ET-only group
Eligibility Criteria
Inclusion Criteria: * Adult male or female over the age of 18 that has served, or is currently serving, in the military. * Current diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview. Exclusion Criteria: * Active psychosis or dementia at screening. * Suicidal ideation with clear intent. * Concurrent enrollment in another clinical trial for PTSD or depression. * Substance use disorders * Visual impairments not allowing use of augmented reality. Visual impairments that are corrected with contact lens visual aid are not considered exclusionary as contacts can be worn under the AR headset. For patients with vision impairment that cannot wear contacts, a diopter value no stronger than -2.00 is acceptable. Exclusion criteria are limited to those factors that would negatively impact the validity of the study findings, or place participants at undue risk.
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