Clinical trial NCT06740487: Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder
Official title: Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PTSD
Post Traumatic Stress Disorder
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Ralph H. Johnson VA Medical Center
name: United States Department of Defense
First posted: 2024-12-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Post-traumatic stress disorder (PTSD) affects 12-14% of military personnel exposed to combat or military sexual trauma. Exposure therapy (ET) is the core of effective treatments for PTSD. During ET, patients are gradually exposed to avoided situations until fear/avoidance diminish. Despite its centrality in treatment, dropout from ET is high. Furthermore, while ET allocates significant therapist time to imaginal exposure to trauma memories, it relies on patients to independently engage in in vivo exposure to real-life situations they avoid (e.g., a crowded room or a grocery store). This limits patients' success in key exposure assignments, and importantly, their ability to return to civilian life functioning and work. Often, patients' symptoms improve, but social and occupational disability persists.

Augmented reality (AR) represents the newest wave of interactive human-computer technology, wherein virtual objects are mixed with physical reality. Instead of a completely synthetic environment (as with virtual reality; VR), AR simply adds to a patient's real physical context. As such, AR is less costly and easier to develop, and most importantly, is far more representative of the environment than VR, because AR IS the patient's environment, albeit with the addition of virtual feared stimuli.

To overcome ET limitations, researchers at the Stress, Trauma and Anxiety Research Clinic (STARC), in the Department of Psychiatry and Behavioral Neurosciences at Wayne State University, have created an AR technology that for the first time, allows the use of advanced AR technology for ET. This technology, called ExpandXR, is being used for treatment of first responders with PTSD. ExpandXR connects the clinician's computer to the AR headset via local area network (LAN) or Wi-Fi and provides a real-time 3D visual of the patient's surroundings on the therapist's computer. The clinician can see the position of the patient and the AR objects in a schematic of the room (not the real room), as well as the characters in patient's field of view. Simple clicks allow the clinician to control which virtual objects are present in the environment, as well as their behavior and movement. Stereo sound is delivered to the patient via speakers inside the headset. The software allows for recording of the number of augmented avatars in patient's field of view at any moment. Patients' subjective units of distress score (SUDS) can be directly entered into the software during the session.

ExpandXR includes 'scenarios' involving exposure to crowds in diverse social contexts. These scenarios have been designed by obtaining feedback from first responders, as well as the clinicians who work with them, while the technology has been developed in collaboration with experts with decades of experience in the gaming industry to ensure the realism needed for this application, and the highest possible overall quality of the product. The scenarios are scalable from very low on the fear hierarchy (e.g., two people talking to each other in a far corner of the room) to higher levels (e.g., a loud gathering with multiple groups of people, both in the patient's field of vision and behind them, with the sound of fireworks in the background). Current fixed scenarios include a gradually crowding party (which with some props could be transformed to a restaurant or bar), a gradually crowding grocery store, a bar/restaurant, a sports event, and office space. Some characters will have military fatigue on. Importantly, these scenarios include the normal life situations that are avoided by people with PTSD due to their trauma and are NOT recreations of the trauma memories. While engaged in a scenario, the patient, wearing the AR headset, can walk around, join groups, and listen to conversations. Some characters are interactive, walking towards the patient and addressing them directly. The clinician's desktop view livestreams the patient's position in space and their point of view (clinician can toggle between views). The exposure hierarchy intensity is easily increased or decreased by clicking arrows. The scenario can be paused and restarted. Sounds effect can be selected and adjusted for each patient. Patients' SUDS can be entered in real-time, and a data file with SUDS, timestamp and the level of exposure is exported at the end of the session. The software also has a library of near 100 diverse characters from which the clinician can choose and apply customized behaviors or interactions with a patient. The clinician can choose a character with specific physical characteristics, define their behavior, and type the content of their speech live. Of note, all these behaviors are normal life behaviors like walking, shaking head, nodding, tapping foot, smiling, looking surprised, etc. This aspect of the technology can be used for customized needs of each patient and their specific avoidances. The technology also allows automated conversations with AI driven characters, for practicing having a normal safe conversation with as stranger.

The technology has been well-received by first responders (a group with experiences relevant to military personnel) and pilot data suggest great success when used in treatment. Patients' initial resistance to ET seems to be an important limiting factor in acceptance of in vivo exposure. For the past several years, some findings from using ARET are that patients are more open to initiating treatment as they cognitively "know" the objects are not real. However, when engaged in the treatment, psychophysiological (SCR), behavioral, and subjective measures indicate that ARET elicits similar level of fear and arousal in response to virtual objects as to real feared objects.

This study will use a fine-tuned version of the above technology, which has been adjusted to specific civilian life needs of veterans and military personnel with PTSD, based on the feedback from national experts in military trauma, and veterans themselves.

Subject Recruitment:

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. Subject recruitment will happen at the Ralph H. Johnson VA Healthcare System (RAJ VAHCS) in Charleston, South Carolina. Potential participants will be contacted by study staff when recruitment derives from the weekly PTSD clinic staff meetings at RAJ VAHCS. The investigators will also post flyers in the RHJ VAHCS, Charleston, and Savannah communities. Potential participants who respond to flyers, or who are referred by other providers, will be directed to the study coordinator where they will review informed consent and have all questions answered. If for any reason the study coordinator and patient cannot meet face-to-face, participants may be contacted via telephone to discuss study parameters. The investigators will also list this study among those listed in our consortium institution's (Medical University of South Carolina) "scresearch.org" web page. Also, primary care and mental health providers of veterans for whom PTSD is suspected may also refer to the study. For individuals that do not meet study inclusion criteria, the study staff will assist with coordinating appropriate care outside of the study.

Treatment will take place at the Ralph H. Johnson VA Healthcare System (RAJ VAHCS) in Charleston, South Carolina. Participants will be randomized into two groups: 20 participants will receive ARET + traditional ET, with the remaining 20 to receive traditional ET only. Participants in both groups will receive 10 90-minute sessions of ET over 5-10 weeks (sessions to occur 1-2x per week). Participants in the ARET + traditional ET group will receive enhanced ET insofar as, 30 minutes of their 90-minute session will be devoted to ARET.

Participants in the ARET group will be fitted with the AR goggles, and the clinician will see the patient's point of view on a desktop computer. The clinician will explain each of the preset scenarios to the patient (e.g., crowded gathering, grocery store, restaurant, bar, office space), and then start with the scenario that patient indicates they find the easiest. The hierarchies of these scenarios are preset and the same for all participants, which mostly involves addition of more characters. At each level, when the patient's SUDS score is 4 or below and the patient gives the go-ahead, the scenario will be increased to the next level. Patients are assured that they will not be surprised, and nothing will happen without their approval. Participants will also be told that they can stop/pause the scenarios at any time. When the first scenario is completed and the patient has SUDS of 4 or below at the highest level of hierarchy exposure, the clinician will leave the room, to allow a sense of control, which is very important for autonomy in real life. Clinician will still be available via intercom.

Throughout the sessions, when each scenario is completed, the patients will move on to another scenario, until they have successfully completed all the scenarios, or have decided to not continue any specific scenario. After that, the clinician will use characters from the character library, and create interactive situations based on specific needs of each patient. Therapy will be conducted based on the principles of conventional exposure therapy. During the exposure, the provider can be in the same room, or a different room in the clinic, but will still be connected to the patient through voice. At any time, if the level of distress due to exposure is determined to be too high, both the patient and the provider can pause or terminate the exposure.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week
timeFrame: Change in score from baseline to post treatment (immediately following the last exposure therapy session).
measure: Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week
timeFrame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
measure: Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week
timeFrame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
measure: Liebowitz Social Anxiety Scale (LSAS-SR)
timeFrame: Change in score from baseline to post treatment (immediately following the last exposure therapy session).
measure: Liebowitz Social Anxiety Scale (LSAS-SR)
timeFrame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
measure: Liebowitz Social Anxiety Scale (LSAS-SR)
timeFrame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change in score from baseline to post treatment (immediately following the last exposure therapy session).
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
Secondary outcomes:
measure: PTSD Checklist (PCL5) - past week
timeFrame: Change in score from baseline to post treatment (immediately following the last exposure therapy session).
measure: PTSD Checklist (PCL5) - past week
timeFrame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
measure: PTSD Checklist (PCL5) - past week
timeFrame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
measure: Social Functioning Questionnaire (AI generated)
timeFrame: Change in score from baseline to post treatment (immediately following the last exposure therapy session).
measure: Social Functioning Questionnaire (AI generated)
timeFrame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
measure: Social Functioning Questionnaire (AI generated)
timeFrame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
measure: Post-Traumatic Avoidance Behavior Questionnaire (PABQ)
timeFrame: Change in score from baseline to post treatment (immediately following the last exposure therapy session).
measure: Post-Traumatic Avoidance Behavior Questionnaire (PABQ)
timeFrame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
measure: Post-Traumatic Avoidance Behavior Questionnaire (PABQ)
timeFrame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
measure: UCLA-Loneliness Scale (short form)
timeFrame: Change in score from baseline to post treatment (immediately following the last exposure therapy session).
measure: UCLA-Loneliness Scale (short form)
timeFrame: Change in score from baseline to post treatment, 3-months after last exposure therapy session
measure: UCLA-Loneliness Scale (short form)
timeFrame: Change in score from baseline to post treatment, 6-months after last exposure therapy session
Other outcomes:
Locations:
Study officials:
affiliation: Ralph H. Johnson VA Health Care System
name: Ron Acierno, PhD
role: PRINCIPAL_INVESTIGATOR
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