Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Traditional Exposure Therapy (ET) Treatment (Behavioral)
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.
干预措施: Stepwise Augmented Reality (AR) Component with Traditional Exposure Treatment for Nonresponders (Behavioral)
结局指标
主要结局
Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week
时间窗: 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)
时间窗: 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
时间窗: 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.
Clinician Administered PTSD Scale-5 Revised (CAPS-5 R) - past week
时间窗: 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
时间窗: 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.
Liebowitz Social Anxiety Scale (LSAS-SR)
时间窗: 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)
时间窗: 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.
PTSD Checklist (PCL5) - past week
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Credibility Expectancy Questionnaire(Change in score from baseline to post treatment, 6-months after last exposure therapy session)
- Social Functioning Questionnaire (AI generated)(Change in score from baseline to post treatment, 6-months after last exposure therapy session)
- Patient Health Questionnaire-9 (PHQ-9)(Change in score from baseline to post treatment, 6-months after last exposure therapy session)
- Post-Traumatic Avoidance Behavior Questionnaire (PABQ)(Change in score from baseline to post treatment, 6-months after last exposure therapy session)
- UCLA-Loneliness Scale (short form)(Change in score from baseline to post treatment, 6-months after last exposure therapy session)
- 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))
- Social Functioning Questionnaire (AI generated)(Change in score from baseline to post treatment, 3-months after last exposure therapy session)
- Post-Traumatic Avoidance Behavior Questionnaire (PABQ)(Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).)
- Post-Traumatic Avoidance Behavior Questionnaire (PABQ)(Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE))
- Post-Traumatic Avoidance Behavior Questionnaire (PABQ)(Change in score from baseline to post treatment, 3-months after last exposure therapy session)
- UCLA-Loneliness Scale (short form)(Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).)
- UCLA-Loneliness Scale (short form)(Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE))
- UCLA-Loneliness Scale (short form)(Change in score from baseline to post treatment, 3-months after last exposure therapy session)
- Credibility Expectancy Questionnaire(Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).)
- Credibility Expectancy Questionnaire(Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE))
- Credibility Expectancy Questionnaire(Change in score from baseline to post treatment, 3-months after last exposure therapy session)
- Patient Health Questionnaire-9 (PHQ-9)(Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).)
- Patient Health Questionnaire-9 (PHQ-9)(Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE))
- Patient Health Questionnaire-9 (PHQ-9)(Change in score from baseline to post treatment, 3-months after last exposure therapy session)
- Satisfaction with Social Roles and Activities - Short Form 8a (PROMIS)(Change in score from baseline to post-treatment (immediately following the 10th exposure therapy session))
研究者
Arash Javanbakht
Director of Stress, Trauma, and Anxiety Research Clinic (STARC)
Wayne State University
