At a glance
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Intelligent Biometrics to Optimize Prolonged Exposure for PTSD
In Brief
A Phase 1 clinical trial evaluating Therapist Guided Prolonged Exposure with BioWare Device and Record Only Prolonged Exposure with BioWare Device for PTSD. Completed, enrolled 40 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.