<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471207</url>
  </required_header>
  <id_info>
    <org_study_id>00094890</org_study_id>
    <nct_id>NCT04471207</nct_id>
  </id_info>
  <brief_title>Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial</brief_title>
  <official_title>Intelligent Biometrics to Optimize Prolonged Exposure for PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zeriscope</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Posttraumatic stress disorder (PTSD) is a debilitating mental health condition that increases&#xD;
      suicide risk and affects up to 20% of military veterans and 8% of the general population.&#xD;
      Prolonged Exposure (PE) is a highly effective behavioral (talk therapy) intervention for&#xD;
      PTSD. However, dropout rates are high (25-30%) and an estimated one-third of patients who&#xD;
      complete PE still report symptoms of PTSD at the end of treatment. This study directly&#xD;
      addresses these limitations by using a clinical trial to evaluate the ability of an&#xD;
      innovative technology system to improve PE therapy for veterans with PTSD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posttraumatic stress disorder (PTSD) is a chronic and debilitating psychiatric condition.&#xD;
      Prolonged Exposure (PE) therapy is a highly effective, evidence-based treatment for PTSD;&#xD;
      however, dropout rates are high and approximately one-third of patients who complete&#xD;
      treatment remain symptomatic. The proposed study will employ a randomized clinical trial&#xD;
      (N=40 treatment-seeking veterans with current PTSD) to evaluate the acceptability,&#xD;
      feasibility and preliminary efficacy of a technological enhancement (IB-PE), and investigate&#xD;
      predictors of outcome by accomplishing the following milestones: (1a) Evaluate ability of&#xD;
      IB-PE (therapist guided vs. record only) in reducing PTSD severity from baseline to end of&#xD;
      treatment; and (2b) Use a variety of in vivo exposures (IVEs) to identify biometric and&#xD;
      behavioral indicators (high heart rate, skin conductance) with high predictive value of&#xD;
      treatment response. We will use a technology system of discrete wearables (camera,&#xD;
      microphone) to allow therapists to accompany participants during IVEs. The system will pair&#xD;
      with a cellular application and record information such as heart rate and skin conductance.&#xD;
      This system will also allow the participant to communicate with the study therapist during&#xD;
      the guided in vivo exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">March 8, 2022</completion_date>
  <primary_completion_date type="Actual">February 3, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Post Traumatic Stress Disorder symptom severity - clinician rated</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Clinician Administered PTSD Scale (CAPS-5) for clinician-rated PTSD symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Post Traumatic Stress Disorder symptom severity - self report</measure>
    <time_frame>10-12 weeks</time_frame>
    <description>Posttraumatic Checklist for DSM-5 (PCL-5) for self-reported symptoms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Intelligent Biometrics - Prolonged Exposure (Therapist Guided).</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the therapist-guided group, Study Therapists will virtually accompany patients during IVEs and use actionable biometric and subjective data during IVEs (e.g., HR, GSR, SUDS) to modify the assignments in real-time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intelligent Biometrics - Prolonged Exposure (Record Only).</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Therapist Guided Prolonged Exposure with BioWare Device</intervention_name>
    <description>Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists will use actionable data during IVEs (e.g., HR, GSR, SUDS) to modify the assignments in real-time.</description>
    <arm_group_label>Intelligent Biometrics - Prolonged Exposure (Therapist Guided).</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Record Only Prolonged Exposure with BioWare Device</intervention_name>
    <description>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.</description>
    <arm_group_label>Intelligent Biometrics - Prolonged Exposure (Record Only).</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female; any race or ethnicity; aged 18-75 years.&#xD;
&#xD;
          2. U.S. Military veteran, any branch or era.&#xD;
&#xD;
          3. Participants must be able to comprehend English.&#xD;
&#xD;
          4. Participants must meet DSM-5 diagnostic criteria for current (i.e., past 6 months)&#xD;
             PTSD (assessed via the Clinician Administered PTSD Scale for DSM-5). Subjects may also&#xD;
             meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion&#xD;
             Criteria) or anxiety disorders (panic disorder, agoraphobia, social phobia,&#xD;
             generalized anxiety disorder, or obsessive compulsive disorder). The inclusion of&#xD;
             subjects with affective and other anxiety disorders is essential because of the marked&#xD;
             frequency of the co-existence of mood and other anxiety disorders among patients with&#xD;
             PTSD.&#xD;
&#xD;
          5. Participants taking psychotropic medications will be required to be maintained on a&#xD;
             stable dose for at least four weeks before study initiation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar&#xD;
             affective disorders. Those participants will be referred clinically to ensure they&#xD;
             have appropriate level of clinical care.&#xD;
&#xD;
          2. Participants meeting DSM-5 criteria for a current (past 6 months) moderate to severe&#xD;
             substance use disorder. Those participants will be referred to addiction treatment&#xD;
             centers at the VA, MUSC and in the local community. Individuals with mild SUD will be&#xD;
             included.&#xD;
&#xD;
          3. Participants considered an immediate suicidal or homicidal risk or who are likely to&#xD;
             require hospitalization during the course of the study for suicidality. Those&#xD;
             participants will be referred clinically for care.&#xD;
&#xD;
          4. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing&#xD;
             medications, which have been initiated during the past 4 weeks.&#xD;
&#xD;
          5. Participants enrolled in ongoing evidence-based behavioral therapy for PTSD who are&#xD;
             not willing to discontinue these therapies for the duration of the trial. Attendance&#xD;
             at therapeutic activities other than study sessions will be closely monitored using&#xD;
             the Treatment Services Review.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Sudie E. Back</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Military</keyword>
  <keyword>Veterans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>December 20, 2022</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471207
org study id: 00094890
nct id: NCT04471207
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Post Traumatic Stress Disorder symptom severity - clinician rated
time frame: 10-12 weeks
description: Clinician Administered PTSD Scale (CAPS-5) for clinician-rated PTSD symptoms
measure: Change in Post Traumatic Stress Disorder symptom severity - self report
time frame: 10-12 weeks
description: Posttraumatic Checklist for DSM-5 (PCL-5) for self-reported symptoms
arm group label: Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
arm group type: Experimental
description: In the therapist-guided group, Study Therapists will virtually accompany patients during IVEs and use actionable biometric and subjective data during IVEs (e.g., HR, GSR, SUDS) to modify the assignments in real-time.
arm group label: Intelligent Biometrics - Prolonged Exposure (Record Only).
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: Therapist Guided Prolonged Exposure with BioWare Device
description: Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists will use actionable data during IVEs (e.g., HR, GSR, SUDS) to modify the assignments in real-time.
arm group label: Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
intervention type: Device
intervention name: Record Only Prolonged Exposure with BioWare Device
description: 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.
arm group label: Intelligent Biometrics - Prolonged Exposure (Record Only).
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Sudie E. Back
investigator title: Professor
mesh term: Stress Disorders, Post-Traumatic
submitted: December 20, 2022