<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/NCT02982538</url>
  </required_header>
  <id_info>
    <org_study_id>W81XWH-12-2-0116</org_study_id>
    <nct_id>NCT02982538</nct_id>
  </id_info>
  <brief_title>Implementation of Prolonged Exposure in the Military</brief_title>
  <official_title>Implementation of Prolonged Exposure in the Army: Is Consultation Necessary for Effective Dissemination?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized study examines how prolonged exposure (PE) therapy, an evidence-based&#xD;
      treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and&#xD;
      implemented in the Army. The study compares two PE training models: Standard PE training,&#xD;
      comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop&#xD;
      plus expert case consultation. In addition, patients with posttraumatic stress symptoms&#xD;
      receiving psychotherapy from participating providers will be invited to participate. After&#xD;
      completing PE training, use of PE components with patients reporting PTS symptoms and&#xD;
      clinical outcomes of these participating patients will be monitored for up to 18 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine how evidence-based therapies (EBTs) such as Prolonged Exposure (PE)&#xD;
      for posttraumatic stress disorder (PTSD) can be successfully disseminated and implemented in&#xD;
      the Army by comparing two PE training models: Standard PE training (workshop only) and&#xD;
      Extended PE training (workshop plus consultation). Up to 180 mental health providers at three&#xD;
      medium-to large Army installations will be randomly assigned to either Standard PE training&#xD;
      or Extended PE training. All providers will complete a 4-day PE workshop, along with the&#xD;
      distribution of training materials and treatment manuals, conducted at the military site by&#xD;
      the Overall Study PI, Dr. Edna Foa, and her team. Following the 4-day workshop, participants&#xD;
      randomized to the Extended PE training will receive weekly phone consultation with a PE&#xD;
      expert on two PE therapy cases. Participants randomized to the Standard PE training group&#xD;
      will not receive any additional consultation following the workshop. Providers will not be&#xD;
      required to use PE therapy with their patients with PTS symptoms; using PE will be optional.&#xD;
      A major outcome of this study is the proportion of the providers PTSD patients that are&#xD;
      offered PE or PE components. The mental health outcomes of providers' PTS patients will also&#xD;
      be monitored as a second major outcome. Patients seeking treatment from participating&#xD;
      providers will be recruited, consented, and assessed by independent evaluators at two time&#xD;
      points to prospectively assess their response to treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">September 2021</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Provider Use of PE Components</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Provider use of PE components will be assessed using a brief checklist of treatment procedures completed by providers directly following therapy sessions with participating patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider Attitudes</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Provider change in self-efficacy and attitudes toward PE will be assessed via a self-report measure administered before and after the PE workshop, and at 3 month intervals until 18 months following the conclusion of training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Posttraumatic Stress Outcomes</measure>
    <time_frame>8-15 sessions of therapy or after 5 months since initial assessment, whichever comes first</time_frame>
    <description>Patient posttraumatic stress symptom severity will be assessed via using the PTSD Symptom Scale - Interview, administered following referral to the study and after 8-15 sessions of therapy, or after 5 months since initial assessment, whichever comes first.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Standard PE Training Condition</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Providers in this condition will complete a 4-day training workshop in PE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extended PE Training Condition</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Providers in this condition will complete a 4-day training workshop in PE and will receive expert PE case consultation on two PE training cases via weekly phone consultation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Extended Training in Prolonged Exposure Therapy for PTSD</intervention_name>
    <description>Extended training in Prolonged Exposure consists of a 4-day PE workshop, followed by expert PE consultation on 2 training cases. PE consultation consists of weekly telephone calls with expert PE therapists at the University of Pennsylvania, who will review video-recordings of providers PE sessions and provide feedback. Consultation is considered complete if the consultant has reviewed a minimum of 12 video-recorded sessions across 2 training cases, and has provided feedback on all of the crucial elements of PE (e.g., rationale, imaginal exposure, in vivo exposure, processing).</description>
    <arm_group_label>Extended PE Training Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Training in Prolonged Exposure Therapy for PTSD</intervention_name>
    <description>Standard training in PE consists of a 4-day professional workshop on Prolonged Exposure Therapy. This is similar to the standard training approach that has been used to train providers in delivery of PE in the Army.</description>
    <arm_group_label>Standard PE Training Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FOR PROVIDERS: 1) Male and female behavioral health providers whose job duties include&#xD;
             providing psychotherapy to adult patients, age ≥ 18,seeking treatment with symptoms of&#xD;
             PTS. Behavioral health providers can include psychologists, social workers,&#xD;
             psychiatric clinical nurse specialists, psychiatrists, and similarly trained&#xD;
             professional providers.2) Twenty percent (or more) of expected caseload comprised of&#xD;
             patients with PTS symptoms according to provider self-report.&#xD;
&#xD;
          -  FOR PATIENTS: 1) Male and female patients age ≥ 18. 2) Receiving treatment from one of&#xD;
             the behavioral health providers participating in this study. 3) Significant PTS&#xD;
             symptoms as determined by a score of 25 or higher on The Clinician-Administered PTSD&#xD;
             Scale for DSM-5 (CAPS-5).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  FOR PROVIDERS: 1) Definite plans to terminate their position or relocate from the Army&#xD;
             base at some point during the first year following training. 2) Extensive previous&#xD;
             training in Prolonged Exposure (PE), defined as participation in a 4-day PE training&#xD;
             workshop at any point prior to the start of the study, and self-reported use of PE&#xD;
             (including both imaginal and in vivo exposure techniques) to treat 4 or more patients&#xD;
             with PTS symptoms in the past year.&#xD;
&#xD;
          -  FOR PATIENTS: 1) Current bipolar disorder I or psychotic disorder (as determined by&#xD;
             the MINI). 2) Evidence of a moderate or severe traumatic brain injury (as determined&#xD;
             by the inability to comprehend the baseline screening questionnaires). 3) Current&#xD;
             suicidal ideation severe enough to warrant immediate attention (as determined by the&#xD;
             MINI and the Beck Scale for Suicidal Ideation).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edna B Foa, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Evans Army Community Hospital (EACH), Ft. Carson</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blanchfield Army Community Hospital (BACH), Ft. Campbell</name>
      <address>
        <city>Fort Campbell North</city>
        <state>Kentucky</state>
        <zip>42223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Army Medical Center (WBAMC), Ft. Bliss</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Edna Foa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>posttraumatic stress symptoms</keyword>
  <keyword>implementation</keyword>
  <keyword>dissemination</keyword>
  <keyword>PTSD</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02982538
org study id: W81XWH-12-2-0116
nct id: NCT02982538
lead sponsor: 
collaborator: 
has dmc: No
This randomized study examines how prolonged exposure (PE) therapy, an evidence-based
      treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and
      implemented in the Army. The study compares two PE training models: Standard PE training,
      comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop
      plus expert case consultation. In addition, patients with posttraumatic stress symptoms
      receiving psychotherapy from participating providers will be invited to participate. After
      completing PE training, use of PE components with patients reporting PTS symptoms and
      clinical outcomes of these participating patients will be monitored for up to 18 months.
This study will examine how evidence-based therapies (EBTs) such as Prolonged Exposure (PE)
      for posttraumatic stress disorder (PTSD) can be successfully disseminated and implemented in
      the Army by comparing two PE training models: Standard PE training (workshop only) and
      Extended PE training (workshop plus consultation). Up to 180 mental health providers at three
      medium-to large Army installations will be randomly assigned to either Standard PE training
      or Extended PE training. All providers will complete a 4-day PE workshop, along with the
      distribution of training materials and treatment manuals, conducted at the military site by
      the Overall Study PI, Dr. Edna Foa, and her team. Following the 4-day workshop, participants
      randomized to the Extended PE training will receive weekly phone consultation with a PE
      expert on two PE therapy cases. Participants randomized to the Standard PE training group
      will not receive any additional consultation following the workshop. Providers will not be
      required to use PE therapy with their patients with PTS symptoms; using PE will be optional.
      A major outcome of this study is the proportion of the providers PTSD patients that are
      offered PE or PE components. The mental health outcomes of providers' PTS patients will also
      be monitored as a second major outcome. Patients seeking treatment from participating
      providers will be recruited, consented, and assessed by independent evaluators at two time
      points to prospectively assess their response to treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Provider Use of PE Components
time frame: Through study completion, an average of 2 years
description: Provider use of PE components will be assessed using a brief checklist of treatment procedures completed by providers directly following therapy sessions with participating patients.
measure: Provider Attitudes
time frame: Through study completion, an average of 2 years
description: Provider change in self-efficacy and attitudes toward PE will be assessed via a self-report measure administered before and after the PE workshop, and at 3 month intervals until 18 months following the conclusion of training.
measure: Patient Posttraumatic Stress Outcomes
time frame: 8-15 sessions of therapy or after 5 months since initial assessment, whichever comes first
description: Patient posttraumatic stress symptom severity will be assessed via using the PTSD Symptom Scale - Interview, administered following referral to the study and after 8-15 sessions of therapy, or after 5 months since initial assessment, whichever comes first.
arm group label: Standard PE Training Condition
arm group type: Other
description: Providers in this condition will complete a 4-day training workshop in PE.
arm group label: Extended PE Training Condition
arm group type: Other
description: Providers in this condition will complete a 4-day training workshop in PE and will receive expert PE case consultation on two PE training cases via weekly phone consultation.
intervention type: Behavioral
intervention name: Extended Training in Prolonged Exposure Therapy for PTSD
description: Extended training in Prolonged Exposure consists of a 4-day PE workshop, followed by expert PE consultation on 2 training cases. PE consultation consists of weekly telephone calls with expert PE therapists at the University of Pennsylvania, who will review video-recordings of providers PE sessions and provide feedback. Consultation is considered complete if the consultant has reviewed a minimum of 12 video-recorded sessions across 2 training cases, and has provided feedback on all of the crucial elements of PE (e.g., rationale, imaginal exposure, in vivo exposure, processing).
arm group label: Extended PE Training Condition
intervention type: Behavioral
intervention name: Standard Training in Prolonged Exposure Therapy for PTSD
description: Standard training in PE consists of a 4-day professional workshop on Prolonged Exposure Therapy. This is similar to the standard training approach that has been used to train providers in delivery of PE in the Army.
arm group label: Standard PE Training Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edna B Foa, Ph.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Edna Foa
investigator title: Principal Investigator
sharing ipd: No