Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Therapist Guided Prolonged Exposure with BioWare Device; Record Only Prolonged Exposure with BioWare Device
Intervention type(s): Device; Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Military; Veterans