Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
South Carolina
Ralph H. Johnson VA Health Care System
RECRUITING
Charleston
Contact Information
Primary
Arash Javanbakht, MD
ajavanba@med.wayne.edu
3135771396
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Traditional Exposure Therapy (ET) Treatment
The active comparator group receives traditional prolonged exposure therapy alone, delivered in 60 minute sessions over 10 days across 5-10 weeks (sessions to occur 2-3x/week, with weekends off). Participants in both groups will be advised to continue in vivo exposure to real life situations (grocery shopping, going out, going to gatherings, etc.) in-between the sessions.
Experimental: Traditional Exposure Therapy (ET) Treatment with addition of Augmented Reality (AR) Component
Participants in the experimental group will begin with 10 60-minute sessions of in person ARET treatment across 5-10 weeks (sessions to occur 2-3x/week, with weekends off). This will involve wearing augmented reality (AR) goggles during exposure therapy to AR scenarios. At session 10, those with PCL score reduction of at least 12 points and a PCL score of below 33 (accepted diagnostic cut-off), will end treatment. Those who do not meet these criteria will continue with 10 sessions of 60-minute PE treatment across 5-10 weeks (sessions to occur 2-3x/week, with weekends off). Participants in both groups will be advised to continue in vivo exposure to real life situations (grocery shopping, going out, going to gatherings, etc.) in-between the sessions.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense, Ralph H. Johnson VA Medical Center
Leads: Wayne State University

This content was sourced from clinicaltrials.gov