Posttraumatic stress disorder (PTSD) is a debilitating mental health condition that increases suicide risk and affects up to 20% of military veterans and 8% of the general population. Prolonged Exposure (PE) is a highly effective behavioral (talk therapy) intervention for PTSD. However, dropout rates are high (25-30%) and an estimated one-third of patients who complete PE still report symptoms of PTSD at the end of treatment. This study directly addresses these limitations by using a clinical trial to evaluate the ability of an innovative technology system to improve PE therapy for veterans with PTSD.
Posttraumatic stress disorder (PTSD) is a chronic and debilitating psychiatric condition. Prolonged Exposure (PE) therapy is a highly effective, evidence-based treatment for PTSD; however, dropout rates are high and approximately one-third of patients who complete treatment remain symptomatic. The proposed study will employ a randomized clinical trial (N=40 treatment-seeking veterans with current PTSD) to evaluate the acceptability, feasibility and preliminary efficacy of a technological enhancement (IB-PE), and investigate predictors of outcome by accomplishing the following milestones: (1a) Evaluate ability of IB-PE (therapist guided vs. record only) in reducing PTSD severity from baseline to end of treatment; and (2b) Use a variety of in vivo exposures (IVEs) to identify biometric and behavioral indicators (high heart rate, skin conductance) with high predictive value of treatment response. We will use a technology system of discrete wearables (camera, microphone) to allow therapists to accompany participants during IVEs. The system will pair with a cellular application and record information such as heart rate and skin conductance. This system will also allow the participant to communicate with the study therapist during the guided in vivo exercises.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists will use actionable data during in vivo exposures (IVEs) (galvanic skin response \[GSR\], heart rate \[HR\], and subjective units of distress \[SUDS\]) to modify the assignments in real-time. All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
In the record-only group, passive data collection will be utilized to collect and store biometric and behavioral data for future offline analyses to investigate predictors of outcome. All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
Medical University of South Carolina
Charleston, South Carolina, United States
Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered assessment for posttraumatic stress symptoms. The assessment is administered at baseline, mid treatment and end of treatment. The CAPS-5 is a 30 item assessment that assesses 20 symptoms of PTSD, with scores ranging from 0-80. Lower scores represent fewer and less sever symptoms of PTSD.
Time frame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
Post Traumatic Stress Disorder Symptom Severity - Self Report
Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) is a twenty item assessment for self-reported symptoms of posttraumatic stress symptoms. Assessment was administered at baseline, and weekly through the end of treatment. Each of the twenty items has a score of 0-4. Lower scores represent fewer posttraumatic stress symptoms. Scores range from 0 to 80.
Time frame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
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