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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Wayne State University
Study ID
NCT06740487
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Traditional Exposure Therapy (ET) Treatment — BEHAVIORAL
    Traditional exposure therapy (ET) includes the following components: (a) psychological education about trauma (sessions 1 and 2), (b) repeated in vivo exposure to trauma-related stimuli (in vivo exercises are assigned as homework during sessions 3 through 9), (c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 - 9; patients listen to session audiotapes for homework between sessions), and (d) relapse prevention strategies and further treatment planning (session 10).
  • Stepwise Augmented Reality (AR) Component with Traditional Exposure Treatment for Nonresponders — BEHAVIORAL
    The Augmented Reality Exposure Therapy component includes the following: (a) 60-minute sessions dedicated to augmented reality exposure therapy (ARET; sessions 1-10), (b) repeated in vivo exposure to trauma-related stimuli (in vivo exercises are assigned as homework during sessions 3 through 9), and (c) relapse prevention strategies and further treatment planning (session 10). During ARET, the clinician guides participant, who is wearing augmented reality (AR) goggles, through preset scenarios during which characters mingle with each other (e.g., grocery store, social gathering), as well as custom scenarios where participant can interact with the character. Those who do not respond to treatment (i.e., responders defined as PCL score reduction of at least 12 points and final PCL score below 33) will then subsequently participate in 10 60-minute sessions of traditional exposure therapy (ET) identical to procedures described for the traditional ET arm.

Study Details

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

Key Dates

Start date
Sep 1, 2025
Status verified
Oct 2025
Primary completion
Jun 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week [ Time Frame: Change in score from baseline to post treatment (immediately following the 10th exposure therapy session). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ralph H. Johnson VA Health Care SystemCharlestonSouth Carolina29403
Ronald Acierno, PhD
[email protected]
713-486-2863

Find similar trials in Charleston, SC

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Ralph H. Johnson VA Health Care System· Charleston, SC

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