Recruiting

ARET & ET

Sponsor:

Wayne State University

Code:

NCT06740487

Conditions

PTSD

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Traditional Exposure Therapy (ET) Treatment

Stepwise Augmented Reality (AR) Component with Traditional Exposure Treatment for Nonresponders

Study Details

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

Conditions

PTSD

Post Traumatic Stress Disorder

Study ID

NCT06740487

Start date

Sep 1, 2025

Status verified date

Oct, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Traditional Exposure Therapy (ET) Treatment

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

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.

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). ]
  • Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week [ Time Frame: Change in score from baseline to post treatment, 3-months after last exposure therapy session ]
  • Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week [ Time Frame: Change in score from baseline to post treatment, 6-months after last exposure therapy session ]
  • Liebowitz Social Anxiety Scale (LSAS-SR) [ Time Frame: Change in score from baseline to post treatment (immediately following the 10th exposure therapy session). ]
  • Liebowitz Social Anxiety Scale (LSAS-SR) [ Time Frame: Change in score from baseline to post treatment, 3-months after last exposure therapy session ]
  • Liebowitz Social Anxiety Scale (LSAS-SR) [ Time Frame: Change in score from baseline to post treatment, 6-months after last exposure therapy session ]
  • PTSD Checklist (PCL5) - past week [ Time Frame: Change in score from baseline to post treatment (immediately following the 10th exposure therapy session). ]
  • PTSD Checklist (PCL5) - past week [ Time Frame: Change in score from baseline to post treatment, 3-months after last exposure therapy session ]
  • PTSD Checklist (PCL5) - past week [ Time Frame: Change in score from baseline to post treatment, 6-months after last exposure therapy session ]

Central Contacts and Locations

Central contacts

Arash Javanbakht, MD

3135771396ajavanba@med.wayne.edu

Locations

Ralph H. Johnson VA Health Care System

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Ronald Acierno, PhD

713-486-2863ronald.acierno@uth.tmc.edu

More Information

Sponsor

Wayne State University

Last update posted

Jan 29, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2026-01-29.