<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/NCT03810456</url>
  </required_header>
  <id_info>
    <org_study_id>D2160-R</org_study_id>
    <secondary_id>5I01RX002160-02</secondary_id>
    <nct_id>NCT03810456</nct_id>
  </id_info>
  <brief_title>Transdiagnostic Cognitive Behavioral Treatment for Anxiety</brief_title>
  <official_title>Improving Veteran Functioning With Intensive Transdiagnostic CBT for Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized controlled trial examining the effectiveness of a transdiagnostic&#xD;
      cognitive behavioral treatment (CBT) in improving Veterans' community reintegration and&#xD;
      quality of life. Veterans with anxiety-based disorders, including posttraumatic stress,&#xD;
      panic, social anxiety, and generalized anxiety disorders (with or without co-occurring&#xD;
      depression) will be randomized to an intensive CBT (iCBT) treatment delivered over one&#xD;
      weekend, standard CBT (sCBT) delivered over 12 weeks or treatment as usual (TAU). The study&#xD;
      will also evaluate the potential of the compressed weekend format of iCBT in producing more&#xD;
      rapid improvement in outcomes and increasing psychotherapy engagement compared with a&#xD;
      standard psychotherapy format. Qualitative interviews will be conducted with Veterans who&#xD;
      receive iCBT and their family members to examine how iCBT and environmental factors impacted&#xD;
      their process of recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current project proposes to evaluate a brief but intensive transdiagnostic CBT that&#xD;
      simultaneously targets multiple anxiety disorders with or without co-occurring depression.&#xD;
      This will be accomplished by evaluating an innovative treatment delivery method that directly&#xD;
      addresses barriers associated with standard psychotherapy delivery. The main objectives are&#xD;
      to (1) determine if an intensive CBT protocol (iCBT) delivered over one weekend can improve&#xD;
      community reintegration, quality of life, and emotional functioning compared with standard&#xD;
      CBT (sCBT) and treatment as usual (TAU); (2) examine the rates of psychotherapy engagement in&#xD;
      iCBT compared with sCBT; and (3) obtain a deeper understanding, through qualitative&#xD;
      interviews with Veterans and their family members, of how iCBT and environmental factors may&#xD;
      impact the process of reintegration and quality of life.&#xD;
&#xD;
      The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic&#xD;
      group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard&#xD;
      group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual&#xD;
      (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based&#xD;
      disorder(s) (with or without co-occurring depression) will be randomized to one of the three&#xD;
      treatment arms. Veterans will be asked to attend a total of four assessments during the study&#xD;
      including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups. Qualitative&#xD;
      interviews will be conducted with Veterans who completed iCBT and family members.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</measure>
    <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
    <description>The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</measure>
    <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
    <description>The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</measure>
    <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
    <description>The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</measure>
    <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
    <description>The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</measure>
    <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
    <description>The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</measure>
    <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
    <description>The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">359</enrollment>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>iCBT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sCBT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Cognitive Behavior Therapy (iCBT)</intervention_name>
    <description>Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
    <arm_group_label>iCBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Cognitive Behavior Therapy (sCBT)</intervention_name>
    <description>Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
    <arm_group_label>sCBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans enrolled to receive VA medical care&#xD;
&#xD;
          -  Current diagnosis of at least one anxiety-based disorder&#xD;
&#xD;
          -  Moderate-to-poor life enjoyment and satisfaction&#xD;
&#xD;
          -  Stable on psychotropic medication 4 weeks prior to participation&#xD;
&#xD;
          -  Willing to be randomized to treatment condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active symptoms of mania or psychosis at baseline&#xD;
&#xD;
          -  Depression with active suicidal ideation/intent&#xD;
&#xD;
          -  Moderate-to-severe cognitive impairment&#xD;
&#xD;
          -  Active drug/alcohol abuse during initial 3 months of study enrollment&#xD;
&#xD;
          -  Undergoing concurrent transdiagnostic CBT for anxiety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Teng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michael E. DeBakey VA Medical Center, Houston, TX</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michael E. DeBakey VA Medical Center, Houston, TX</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>October 7, 2022</results_first_submitted>
  <results_first_submitted_qc>October 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 28, 2023</results_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Behavior Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03810456/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03810456/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Veterans at the Michael E. DeBakey VA Medical Center and affiliated community based outpatient clinics were enrolled in this study from 08/1/2018 to 05/31/2021. Veterans were recruited through direct referrals and advertisements.</recruitment_details>
      <pre_assignment_details>Enrolled participants were excluded from the study prior to randomization if they did not meet study inclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
          <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
        </group>
        <group group_id="P2">
          <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
          <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
        </group>
        <group group_id="P3">
          <title>TAU (Treatment as Usual)</title>
          <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrolled and Randomized</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="99"/>
                <participants group_id="P3" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="67">These individuals may have received standard care.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Urgent Family Matters</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Scheduling Conflicts</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Longer Interested</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transportation Issues</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1 Month Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Relocated to Different State</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3 Month Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6 Month Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One participant randomized to the sCBT arm was excluded from analyses due to not meeting study inclusion criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
          <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
        </group>
        <group group_id="B2">
          <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
          <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
        </group>
        <group group_id="B3">
          <title>TAU (Treatment a Usual)</title>
          <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
        </group>
        <group group_id="B4">
          <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="99"/>
            <count group_id="B2" value="98"/>
            <count group_id="B3" value="67"/>
            <count group_id="B4" value="264"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="42.7" spread="11.2"/>
                    <measurement group_id="B2" value="43.9" spread="12.2"/>
                    <measurement group_id="B3" value="43.6" spread="11.9"/>
                    <measurement group_id="B4" value="43.4" spread="11.7"/>
                  </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="35"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="11"/>
                  </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="99"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
        <description>The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.</description>
        <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
        <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
        <group_list>
          <group group_id="O1">
            <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O2">
            <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O3">
            <title>TAU (Treatment as Usual)</title>
            <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
          <description>The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.</description>
          <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.21" spread="0.7"/>
                    <measurement group_id="O2" value="4.18" spread="0.6"/>
                    <measurement group_id="O3" value="4.17" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="0.9"/>
                    <measurement group_id="O2" value="4.44" spread=".8"/>
                    <measurement group_id="O3" value="4.18" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.57" spread=".7"/>
                    <measurement group_id="O2" value="4.54" spread=".9"/>
                    <measurement group_id="O3" value="4.34" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.70" spread="0.7"/>
                    <measurement group_id="O2" value="4.52" spread="0.8"/>
                    <measurement group_id="O3" value="4.36" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
        <description>The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.</description>
        <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
        <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
        <group_list>
          <group group_id="O1">
            <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O2">
            <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O3">
            <title>TAU (Treatment as Usual)</title>
            <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
          <description>The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.</description>
          <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" spread="0.8"/>
                    <measurement group_id="O2" value="4.34" spread="0.7"/>
                    <measurement group_id="O3" value="4.36" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="0.9"/>
                    <measurement group_id="O2" value="4.44" spread="0.8"/>
                    <measurement group_id="O3" value="4.18" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.86" spread="0.9"/>
                    <measurement group_id="O2" value="4.52" spread="0.9"/>
                    <measurement group_id="O3" value="4.40" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.70" spread="0.7"/>
                    <measurement group_id="O2" value="4.52" spread="0.8"/>
                    <measurement group_id="O3" value="4.36" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
        <description>The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.</description>
        <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
        <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
        <group_list>
          <group group_id="O1">
            <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O2">
            <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O3">
            <title>TAU (Treatment as Usual)</title>
            <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
          <description>The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.</description>
          <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="1.0"/>
                    <measurement group_id="O2" value="4.26" spread="1.2"/>
                    <measurement group_id="O3" value="4.15" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.80" spread="1.1"/>
                    <measurement group_id="O2" value="4.51" spread="1.0"/>
                    <measurement group_id="O3" value="4.31" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.86" spread="0.9"/>
                    <measurement group_id="O2" value="4.60" spread="1.0"/>
                    <measurement group_id="O3" value="4.40" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.96" spread="0.8"/>
                    <measurement group_id="O2" value="4.63" spread="1.0"/>
                    <measurement group_id="O3" value="4.45" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
        <description>The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.</description>
        <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
        <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
        <group_list>
          <group group_id="O1">
            <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O2">
            <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O3">
            <title>TAU (Treatment as Usual)</title>
            <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
          <description>The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.</description>
          <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8" spread="11.2"/>
                    <measurement group_id="O2" value="31.7" spread="10.9"/>
                    <measurement group_id="O3" value="32.0" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" spread="12.6"/>
                    <measurement group_id="O2" value="25.9" spread="10.3"/>
                    <measurement group_id="O3" value="26.3" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" spread="12.2"/>
                    <measurement group_id="O2" value="25.6" spread="11.8"/>
                    <measurement group_id="O3" value="26.7" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" spread="11.6"/>
                    <measurement group_id="O2" value="24.1" spread="11.4"/>
                    <measurement group_id="O3" value="27.0" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
        <description>The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.</description>
        <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
        <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
        <group_list>
          <group group_id="O1">
            <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O2">
            <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O3">
            <title>TAU (Treatment as Usual)</title>
            <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
          <description>The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.</description>
          <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4" spread="7.0"/>
                    <measurement group_id="O2" value="34.8" spread="5.5"/>
                    <measurement group_id="O3" value="33.6" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" spread="9.7"/>
                    <measurement group_id="O2" value="40.7" spread="8.4"/>
                    <measurement group_id="O3" value="37.4" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" spread="10.6"/>
                    <measurement group_id="O2" value="42.0" spread="8.9"/>
                    <measurement group_id="O3" value="38.3" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.7" spread="10.1"/>
                    <measurement group_id="O2" value="42.5" spread="8.8"/>
                    <measurement group_id="O3" value="38.0" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
        <description>The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.</description>
        <time_frame>Baseline, 1 Month, 3 Month, 6 Month Follow Ups</time_frame>
        <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
        <group_list>
          <group group_id="O1">
            <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O2">
            <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
            <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
          </group>
          <group group_id="O3">
            <title>TAU (Treatment as Usual)</title>
            <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups</title>
          <description>The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.</description>
          <population>The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.0" spread="10.7"/>
                    <measurement group_id="O2" value="31.0" spread="10.6"/>
                    <measurement group_id="O3" value="32.7" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5" spread="13.4"/>
                    <measurement group_id="O2" value="24.6" spread="11.8"/>
                    <measurement group_id="O3" value="29.8" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" spread="12.7"/>
                    <measurement group_id="O2" value="24.8" spread="13.2"/>
                    <measurement group_id="O3" value="28.5" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Follow Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" spread="12.0"/>
                    <measurement group_id="O2" value="24.4" spread="13.5"/>
                    <measurement group_id="O3" value="28.8" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years, 7 months</time_frame>
      <desc>Adverse events were systematically evaluated throughout the course of the study, from baseline through the last follow-up period. At each time point, medical records for each participant were reviewed and symptoms were monitored through measures administered to each participant. One participant randomized to the sCBT arm was excluded from analyses due to not meeting study inclusion criteria.</desc>
      <group_list>
        <group group_id="E1">
          <title>iCBT (Intensive Cognitive Behavioral Therapy)</title>
          <description>Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.&#xD;
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
        </group>
        <group group_id="E2">
          <title>sCBT (Standard Cognitive Behavioral Therapy)</title>
          <description>Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.&#xD;
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.</description>
        </group>
        <group group_id="E3">
          <title>TAU (Treatment as Usual)</title>
          <description>Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.</description>
        </group>
      </group_list>
      <serious_events>
        <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="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Due to the COVID-19 pandemic, all research was placed on hold for several months. All study procedures for this project had to be converted to virtual telehealth delivery. This change in modality (including intervention delivery) may have impacted study outcomes and resulted in underpowered analyses.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Ellen Teng</name_or_title>
      <organization>Michael E. DeBakey VA Medical Center</organization>
      <phone>(713) 578-5513</phone>
      <email>Ellen.Teng@va.gov</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/NCT03810456
org study id: D2160-R
secondary id: 5I01RX002160-02
nct id: NCT03810456
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is a randomized controlled trial examining the effectiveness of a transdiagnostic
      cognitive behavioral treatment (CBT) in improving Veterans' community reintegration and
      quality of life. Veterans with anxiety-based disorders, including posttraumatic stress,
      panic, social anxiety, and generalized anxiety disorders (with or without co-occurring
      depression) will be randomized to an intensive CBT (iCBT) treatment delivered over one
      weekend, standard CBT (sCBT) delivered over 12 weeks or treatment as usual (TAU). The study
      will also evaluate the potential of the compressed weekend format of iCBT in producing more
      rapid improvement in outcomes and increasing psychotherapy engagement compared with a
      standard psychotherapy format. Qualitative interviews will be conducted with Veterans who
      receive iCBT and their family members to examine how iCBT and environmental factors impacted
      their process of recovery.
The current project proposes to evaluate a brief but intensive transdiagnostic CBT that
      simultaneously targets multiple anxiety disorders with or without co-occurring depression.
      This will be accomplished by evaluating an innovative treatment delivery method that directly
      addresses barriers associated with standard psychotherapy delivery. The main objectives are
      to (1) determine if an intensive CBT protocol (iCBT) delivered over one weekend can improve
      community reintegration, quality of life, and emotional functioning compared with standard
      CBT (sCBT) and treatment as usual (TAU); (2) examine the rates of psychotherapy engagement in
      iCBT compared with sCBT; and (3) obtain a deeper understanding, through qualitative
      interviews with Veterans and their family members, of how iCBT and environmental factors may
      impact the process of reintegration and quality of life.

      The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic
      group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard
      group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual
      (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based
      disorder(s) (with or without co-occurring depression) will be randomized to one of the three
      treatment arms. Veterans will be asked to attend a total of four assessments during the study
      including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups. Qualitative
      interviews will be conducted with Veterans who completed iCBT and family members.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.
measure: CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
description: The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.
measure: CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
description: The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.
measure: CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
description: The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.
measure: BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
description: The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.
measure: QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
description: The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.
measure: BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
description: The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.
arm group label: iCBT
arm group type: Active Comparator
description: Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
arm group label: sCBT
arm group type: Active Comparator
description: Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
arm group label: TAU
arm group type: No Intervention
description: Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
intervention type: Behavioral
intervention name: Intensive Cognitive Behavior Therapy (iCBT)
description: Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
arm group label: iCBT
intervention type: Behavioral
intervention name: Standard Cognitive Behavior Therapy (sCBT)
description: Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
arm group label: sCBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ellen Teng, PhD
role: Principal Investigator
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to the COVID-19 pandemic, all research was placed on hold for several months. All study procedures for this project had to be converted to virtual telehealth delivery. This change in modality (including intervention delivery) may have impacted study outcomes and resulted in underpowered analyses.
point of contact: 