NCT06740487 · Wayne State University
Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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).
BEHAVIORAL
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 measures
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).
The CAPS-5 R is a 30-item structured interview conducted by a clinician with a patient, to assess for presence of PTSD and/or severity of PTSD symptoms, according to the DSM-5 criteria (prior text generated with help of AI). For each item, the clinician asks the patient the frequency with which they've had a specific problem in the past month, in addition to more specific questions depending on the problem being explored.
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
The CAPS-5 R is a 30-item structured interview conducted by a clinician with a patient, to assess for presence of PTSD and/or severity of PTSD symptoms, according to the DSM-5 criteria (prior text generated with help of AI). For each item, the clinician asks the patient the frequency with which they've had a specific problem in the past month, in addition to more specific questions depending on the problem being explored.
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
The CAPS-5 R is a 30-item structured interview conducted by a clinician with a patient, to assess for presence of PTSD and/or severity of PTSD symptoms, according to the DSM-5 criteria (prior text generated with help of AI). For each item, the clinician asks the patient the frequency with which they've had a specific problem in the past month, in addition to more specific questions depending on the problem being explored.
Liebowitz Social Anxiety Scale (LSAS-SR)
Time frame: Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).
The LSAS-SR is a 24-item structured interview conducted by a clinician with a patient, that assesses for presence of social anxiety disorder. Each item asks two questions about the particular item. Respondents rate the first question of the item on a 4-point Likert scale ranging from 0 ("None") to 3 ("Severe"), indicating how anxious or fearful they feel in a specific situation. Respondents rate the second question of the item on a 4-point Likert scale ranging from 0 ("Never") to 3 ("Usually") indicating how often they avoid a specific situation.
Liebowitz Social Anxiety Scale (LSAS-SR)
Time frame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
The LSAS-SR is a 24-item structured interview conducted by a clinician with a patient, that assesses for presence of social anxiety disorder. Each item asks two questions about the particular item. Respondents rate the first question of the item on a 4-point Likert scale ranging from 0 ("None") to 3 ("Severe"), indicating how anxious or fearful they feel in a specific situation. Respondents rate the second question of the item on a 4-point Likert scale ranging from 0 ("Never") to 3 ("Usually") indicating how often they avoid a specific situation.
Liebowitz Social Anxiety Scale (LSAS-SR)
Time frame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
The LSAS-SR is a 24-item structured interview conducted by a clinician with a patient, that assesses for presence of social anxiety disorder. Each item asks two questions about the particular item. Respondents rate the first question of the item on a 4-point Likert scale ranging from 0 ("None") to 3 ("Severe"), indicating how anxious or fearful they feel in a specific situation. Respondents rate the second question of the item on a 4-point Likert scale ranging from 0 ("Never") to 3 ("Usually") indicating how often they avoid a specific situation.
PTSD Checklist (PCL5) - past week
Time frame: Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).
The PCL-5\_Past Week is a 20-item structured interview conducted by a clinician with a patient, that assesses presence and severity of PTSD symptoms related to a very stressful experience. Respondents rate each item on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"), indicating how much they have been bothered by each symptom in the past week.
PTSD Checklist (PCL5) - past week
Time frame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
The PCL-5\_Past Week is a 20-item structured interview conducted by a clinician with a patient, that assesses presence and severity of PTSD symptoms related to a very stressful experience. Respondents rate each item on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"), indicating how much they have been bothered by each symptom in the past week.
PTSD Checklist (PCL5) - past week
Time frame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
The PCL-5\_Past Week is a 20-item structured interview conducted by a clinician with a patient, that assesses presence and severity of PTSD symptoms related to a very stressful experience. Respondents rate each item on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"), indicating how much they have been bothered by each symptom in the past week.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Charleston, South Carolina
Collaborators
Ralph H. Johnson VA Medical Center, United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations