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

NCT06740487 | Recruiting

• 2 other identifiers: MUSC IRB#: Pro00135785HT9425-24-1-0358
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week

  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.

  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

  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.

  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

  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.

  Change in score from baseline to post treatment, 6-months after last exposure therapy session

• Liebowitz Social Anxiety Scale (LSAS-SR)

  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.

  Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).

• Liebowitz Social Anxiety Scale (LSAS-SR)

  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.

  Change in score from baseline to post treatment, 3-months after last exposure therapy session

• Liebowitz Social Anxiety Scale (LSAS-SR)

  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.

  Change in score from baseline to post treatment, 6-months after last exposure therapy session

• PTSD Checklist (PCL5) - past week

  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.

  Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).

• PTSD Checklist (PCL5) - past week

  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.

  Change in score from baseline to post treatment, 3-months after last exposure therapy session

• PTSD Checklist (PCL5) - past week

  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.

  Change in score from baseline to post treatment, 6-months after last exposure therapy session

Secondary Outcomes (24)

• Clinician Administered PTSD Scale 5 Revised (CAPS-5 R)

  Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE)

• Liebowitz Social Anxiety Scale (LSAS-SR)

  Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE)

• PTSD Checklist (PCL5)

  Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE)

• Social Functioning Questionnaire (AI generated)

  Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).

• Social Functioning Questionnaire (AI generated)

  Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE)

Study Arms (2)

Traditional Exposure Therapy (ET) Treatment

ACTIVE COMPARATOR

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.

Behavioral: Traditional Exposure Therapy (ET) Treatment

Traditional Exposure Therapy (ET) Treatment with addition of Augmented Reality (AR) Component

EXPERIMENTAL

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.

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

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).

Traditional Exposure Therapy (ET) Treatment

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.

Traditional Exposure Therapy (ET) Treatment with addition of Augmented Reality (AR) Component

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active psychosis or dementia at screening.
• Suicidal ideation with clear intent.
• Concurrent enrollment in another clinical trial for PTSD or depression.
• Substance use disorders

Sponsors & Collaborators

• Wayne State University: lead
• Ralph H. Johnson VA Medical Center: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, 29403, United States

RECRUITING

Related Publications (13)

• Chu JA. Posttraumatic stress disorder: Beyond DSM-IV. Am J Psychiatry. 2010 Jun;167(6):615-7. doi: 10.1176/appi.ajp.2010.10030310. No abstract available.

  PMID: 20516157 BACKGROUND

• Keane TM, Wolfe J. Comorbidity in post-traumatic stress disorder: An analysis of community and clinical studies. Journal of Applied Social Psychology. 1990;20(21, Pt 1):1776-1788. doi:10.1111/j.1559-1816.1990.tb01511.x

  BACKGROUND

• Kulka RA, Schlenger WE, Fairbank JA, et al. Trauma and the Vietnam war generation: Report of findings from the National Vietnam Veterans Readjustment Study. Trauma and the Vietnam war generation: Report of findings from the National Vietnam Veterans Readjustment Study. Brunner/Mazel; 1990:xxix, 322-xxix, 322.

  BACKGROUND

• Dohrenwend BP, Turner JB, Turse NA, Adams BG, Koenen KC, Marshall R. The psychological risks of Vietnam for U.S. veterans: a revisit with new data and methods. Science. 2006 Aug 18;313(5789):979-82. doi: 10.1126/science.1128944.

  PMID: 16917066 BACKGROUND

• Fulton JJ, Calhoun PS, Wagner HR, Schry AR, Hair LP, Feeling N, Elbogen E, Beckham JC. The prevalence of posttraumatic stress disorder in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans: a meta-analysis. J Anxiety Disord. 2015 Apr;31:98-107. doi: 10.1016/j.janxdis.2015.02.003. Epub 2015 Feb 19.

  PMID: 25768399 BACKGROUND

• Frueh BC, Elhai JD, Grubaugh AL, Monnier J, Kashdan TB, Sauvageot JA, Hamner MB, Burkett BG, Arana GW. Documented combat exposure of US veterans seeking treatment for combat-related post-traumatic stress disorder. Br J Psychiatry. 2005 Jun;186:467-72; discussion 473-5. doi: 10.1192/bjp.186.6.467.

  PMID: 15928355 BACKGROUND

• Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.

  PMID: 15229303 BACKGROUND

• Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.

  PMID: 16507803 BACKGROUND

• Foa EB, Hembree EA, Rothbaum BO. Prolonged exposure therapy for PTSD: Emotional processing of traumatic experiences: Therapist guide. Prolonged exposure therapy for PTSD: Emotional processing of traumatic experiences: Therapist guide. Oxford University Press; 2007:viii, 146-viii, 146.

  BACKGROUND

• Kehle-Forbes SM, Meis LA, Spoont MR, Polusny MA. Treatment initiation and dropout from prolonged exposure and cognitive processing therapy in a VA outpatient clinic. Psychol Trauma. 2016 Jan;8(1):107-114. doi: 10.1037/tra0000065. Epub 2015 Jun 29.

  PMID: 26121175 BACKGROUND

• Bouton ME, Bolles RC. Contextual control of the extinction of conditioned fear. Learning and Motivation. 1979/11/01/ 1979;10(4):445-466. doi:https://doi.org/10.1016/0023-9690(79)90057-2

  BACKGROUND

• Javanbakht A, Madaboosi S, Grasser LR. Real-life contextualization of exposure therapy using augmented reality: A pilot clinical trial of a novel treatment method. Ann Clin Psychiatry. 2021 Nov;33(4):220-231. doi: 10.12788/acp.0042.

  PMID: 34672925 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics; Elements

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Ron Acierno, PhD

  Ralph H. Johnson VA Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arash Javanbakht, MD

CONTACT

3135771396; ajavanba@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Stress, Trauma, and Anxiety Research Clinic (STARC)

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-10

Locations

US (1)