Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Therapist Guided Prolonged Exposure with BioWare Device; Record Only Prolonged Exposure with BioWare Device
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PTSD; Military; Veterans

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female; any race or ethnicity; aged 18-75 years.

          2. U.S. Military veteran, any branch or era.

          3. Participants must be able to comprehend English.

          4. Participants must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5) diagnostic criteria for current (i.e., past 6 months) posttraumatic
             stress disorder (PTSD) (assessed via the Clinician Administered PTSD Scale for DSM-5).
             Subjects may also meet criteria for a mood disorder (except bipolar affective
             disorder, see Exclusion Criteria) or anxiety disorders (panic disorder, agoraphobia,
             social phobia, generalized anxiety disorder, or obsessive compulsive disorder). The
             inclusion of subjects with affective and other anxiety disorders is essential because
             of the marked frequency of the co-existence of mood and other anxiety disorders among
             patients with PTSD.

          5. Participants taking psychotropic medications will be required to be maintained on a
             stable dose for at least four weeks before study initiation.

        Exclusion Criteria:

          1. Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar
             affective disorders. Those participants will be referred clinically to ensure they
             have appropriate level of clinical care.

          2. Participants meeting DSM-5 criteria for a current (past 6 months) moderate to severe
             substance use disorder. Those participants will be referred to addiction treatment
             centers at the Veterans Affairs, Medical University of South Carolina and in the local
             community. Individuals with mild substance use disorder (SUD) will be included.

          3. Participants considered an immediate suicidal or homicidal risk or who are likely to
             require hospitalization during the course of the study for suicidality. Those
             participants will be referred clinically for care.

          4. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing
             medications, which have been initiated during the past 4 weeks.

          5. Participants enrolled in ongoing evidence-based behavioral therapy for PTSD who are
             not willing to discontinue these therapies for the duration of the trial. Attendance
             at therapeutic activities other than study sessions will be closely monitored using
             the Treatment Services Review.