Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWayne State University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active psychosis or dementia at screening.
Suicidal ideation with clear intent.
Concurrent enrollment in another clinical trial for PTSD or depression.
Substance use disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Traditional Exposure Therapy (ET) Treatment
BehavioralTraditional 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
BehavioralThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Traditional Exposure Therapy (ET) TreatmentActive comparator 1 intervention
Group B: Traditional Exposure Therapy (ET) Treatment with addition of Augmented Reality (AR) ComponentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).2
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.
Time frame
Change in score from baseline to post treatment, 3-months after last exposure therapy session3
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.
Time frame
Change in score from baseline to post treatment, 6-months after last exposure therapy session4
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.
Time frame
Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).Secondary outcomes
1
Clinician Administered PTSD Scale 5 Revised (CAPS-5 R)
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.
Time frame
Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE)2
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.
Time frame
Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE)3
PTSD Checklist (PCL5)
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.
Time frame
Change in score from baseline to post-treatment (Week 20; immediately following completion of the 20th session for participants who complete ARET+PE)4
Social Functioning Questionnaire (AI generated)
The Social Functioning Questionnaire (AI generated) is a 10-item self-report questionnaire that assesses presence of social dysfunction across various situations of daily living. Respondents rate each item on a 5-point Likert scale ranging from 0 ("Never") to 5 ("Always"), indicating how much they have been bothered by the situation in the past week.
Time frame
Change in score from baseline to post treatment (immediately following the 10th exposure therapy session).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wayne State University
Lead sponsor
Ralph H. Johnson VA Medical Center
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov