<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/NCT03033602</url>
  </required_header>
  <id_info>
    <org_study_id>W81WH-15-1-0391</org_study_id>
    <nct_id>NCT03033602</nct_id>
  </id_info>
  <brief_title>Brief Treatment for Posttraumatic Stress Disorder</brief_title>
  <official_title>Brief Treatment for PTSD: Enhancing Retention and Engagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston VA Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston VA Research Institute, Inc.</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>
      The primary goal of this study is to examine whether a brief treatment approach for PTSD is&#xD;
      equally efficacious in the treatment of active duty service members relative to a first line&#xD;
      treatment approach that requires much greater treatment dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this randomized clinical trial is to investigate if a brief, written intervention&#xD;
      for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior&#xD;
      compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition&#xD;
      only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis&#xD;
      of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in&#xD;
      symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and&#xD;
      Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the&#xD;
      CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2015</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinician Administered PTSD Scale, 5 (CAPS-5)</measure>
    <time_frame>Change from baseline to 10-, 20-, 30-weeks post first treatment session</time_frame>
    <description>The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Written exposure therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 sessions of imaginal exposure therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPT, cognitive only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 sessions of cognitive therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>written exposure therapy</intervention_name>
    <description>five sessions of writing about traumatic experience.</description>
    <arm_group_label>Written exposure therapy</arm_group_label>
    <other_name>WET</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CPT, cognitive only</intervention_name>
    <description>12 sessions of cognitive therapy related to traumatic experience.</description>
    <arm_group_label>CPT, cognitive only</arm_group_label>
    <other_name>CPT-C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female active duty military personnel who have deployed in support of a&#xD;
             post-9/11 conflict seeking treatment for PTSD&#xD;
&#xD;
          -  Diagnosis of PTSD&#xD;
&#xD;
          -  Ability to speak, read and write English&#xD;
&#xD;
          -  Not currently engaged in psychosocial treatment for PTSD&#xD;
&#xD;
          -  Individuals taking psychotropic medications agree to work with their prescriber to&#xD;
             remain on stable doses of any prescribed psychotropic medications for the duration of&#xD;
             the intervention and through the first follow-up assessment as much as possible and as&#xD;
             medically indicated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current suicide or homicide risk meriting crisis intervention&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Moderate to severe brain damage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denise Sloan, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston VA Research Institute, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ft. Hood</name>
      <address>
        <city>Killeen</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center, San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.</citation>
    <PMID>35015065</PMID>
  </reference>
  <reference>
    <citation>Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. Contemp Clin Trials Commun. 2019 Dec 10;17:100507. doi: 10.1016/j.conctc.2019.100507. eCollection 2020 Mar.</citation>
    <PMID>31890987</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>March 3, 2022</results_first_submitted>
  <results_first_submitted_qc>July 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2023</results_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">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be made available upon written request to the PI.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>12 months after publication of the primary outcomes.</ipd_time_frame>
    <ipd_access_criteria>Written request to the PI describing rationale for why data is needed and what will be done with data.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03033602/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Written Exposure Therapy</title>
          <description>5 sessions of imaginal exposure therapy.&#xD;
written exposure therapy: five sessions of writing about traumatic experience.</description>
        </group>
        <group group_id="P2">
          <title>CPT, Cognitive Only</title>
          <description>12 sessions of cognitive therapy.&#xD;
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>discontinued for medical reason or decision by study team</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Written Exposure Therapy</title>
          <description>5 sessions of imaginal exposure therapy.&#xD;
written exposure therapy: five sessions of writing about traumatic experience.</description>
        </group>
        <group group_id="B2">
          <title>CPT, Cognitive Only</title>
          <description>12 sessions of cognitive therapy.&#xD;
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="85"/>
            <count group_id="B2" value="84"/>
            <count group_id="B3" value="169"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="169"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.98" spread="6.86"/>
                    <measurement group_id="B2" value="33.32" spread="8.22"/>
                    <measurement group_id="B3" value="33.65" spread="8.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinician Administered PTSD Scale, 5 (CAPS-5)</title>
        <description>The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.</description>
        <time_frame>Change from baseline to 10-, 20-, 30-weeks post first treatment session</time_frame>
        <population>Non-inferiority margin</population>
        <group_list>
          <group group_id="O1">
            <title>Written Exposure Therapy</title>
            <description>5 sessions of imaginal exposure therapy.&#xD;
written exposure therapy: five sessions of writing about traumatic experience.</description>
          </group>
          <group group_id="O2">
            <title>CPT, Cognitive Only</title>
            <description>12 sessions of cognitive therapy.&#xD;
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinician Administered PTSD Scale, 5 (CAPS-5)</title>
          <description>The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.</description>
          <population>Non-inferiority margin</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>10-week assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.55" spread="1.13"/>
                    <measurement group_id="O2" value="25.12" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 week assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.59" spread="1.45"/>
                    <measurement group_id="O2" value="25.41" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 week assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.77" spread="1.61"/>
                    <measurement group_id="O2" value="24.97" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Written Exposure Therapy</title>
          <description>5 sessions of imaginal exposure therapy.&#xD;
written exposure therapy: five sessions of writing about traumatic experience.</description>
        </group>
        <group group_id="E2">
          <title>CPT, Cognitive Only</title>
          <description>12 sessions of cognitive therapy.&#xD;
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>psychiatric hospitalization</sub_title>
                <description>admitted to psychiatric unit due to suicidality</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>increase in anxiety symptoms</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Participants who dropped out prematurely of treatment were less likely to return for subsequent assessments.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Denise Sloan, Professor of Psychiatry</name_or_title>
      <organization>VA Boston Healthcare System &amp; Boston University School of Medicine</organization>
      <phone>857-364-6333</phone>
      <email>dsloan@bu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03033602
org study id: W81WH-15-1-0391
nct id: NCT03033602
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary goal of this study is to examine whether a brief treatment approach for PTSD is
      equally efficacious in the treatment of active duty service members relative to a first line
      treatment approach that requires much greater treatment dose.
The goal of this randomized clinical trial is to investigate if a brief, written intervention
      for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior
      compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition
      only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis
      of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in
      symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and
      Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the
      CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinician Administered PTSD Scale, 5 (CAPS-5)
time frame: Change from baseline to 10-, 20-, 30-weeks post first treatment session
description: The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.
arm group label: Written exposure therapy
arm group type: Experimental
description: 5 sessions of imaginal exposure therapy.
arm group label: CPT, cognitive only
arm group type: Active Comparator
description: 12 sessions of cognitive therapy.
intervention type: Behavioral
intervention name: written exposure therapy
description: five sessions of writing about traumatic experience.
arm group label: Written exposure therapy
other name: WET
intervention type: Behavioral
intervention name: CPT, cognitive only
description: 12 sessions of cognitive therapy related to traumatic experience.
arm group label: CPT, cognitive only
other name: CPT-C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Denise Sloan, Ph.D.
role: Principal Investigator
affiliation: Boston VA Research Institute, Inc.
facility: 
facility: 
country: United States
citation: Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
PMID: 35015065
citation: Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. Contemp Clin Trials Commun. 2019 Dec 10;17:100507. doi: 10.1016/j.conctc.2019.100507. eCollection 2020 Mar.
PMID: 31890987
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data will be made available upon written request to the PI.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 12 months after publication of the primary outcomes.
ipd access criteria: Written request to the PI describing rationale for why data is needed and what will be done with data.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Participants who dropped out prematurely of treatment were less likely to return for subsequent assessments.
point of contact: 