<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/NCT03794089</url>
  </required_header>
  <id_info>
    <org_study_id>CDX 18-006</org_study_id>
    <nct_id>NCT03794089</nct_id>
  </id_info>
  <brief_title>Reducing Anxiety and Stress in Primary Care Patients</brief_title>
  <official_title>Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)</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>
      Anxiety is common among primary care patients, but is undertreated. The purpose of this study&#xD;
      is to evaluate whether a brief anxiety treatment designed for VA primary care is more&#xD;
      effective at reducing anxiety symptoms in Veterans compared to usual care. The investigators&#xD;
      will also examine whether Veterans like the brief treatment and whether the treatment can be&#xD;
      feasibly delivered in primary care. Forty-eight adult Veteran primary care patients from the&#xD;
      Syracuse VAMC who are experiencing anxiety symptoms will be recruited and randomly assigned&#xD;
      to receive the brief anxiety treatment or usual care. The brief treatment consists of up to&#xD;
      six 30-minute sessions with a cognitive-behavioral skills focus. The investigators will&#xD;
      compare anxiety symptom severity between the two groups at baseline and at post-assessment 16&#xD;
      weeks later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Rationale: Many Veteran primary care patients experience impairing symptoms of&#xD;
      anxiety, but rates of treatment are low. Primary Care-Mental Health Integration (PC-MHI), in&#xD;
      which mental health clinicians provide brief treatment in the primary care setting, can&#xD;
      bridge the gap between demand for, and availability of, anxiety treatment. However, brief&#xD;
      anxiety interventions suitable for use in the PC-MHI setting are needed. Developing an&#xD;
      effective brief PC-MHI intervention for anxiety would address a gap in VA treatment options&#xD;
      and facilitate high quality healthcare that improves treatment engagement, clinical outcomes,&#xD;
      and patient experience. To ensure maximum reach, this intervention should accommodate a&#xD;
      variety of subthreshold and diagnostic anxiety presentations, as well as comorbid depression.&#xD;
&#xD;
      Objectives: The overall goal of this research program is to develop, refine, and evaluate a&#xD;
      brief anxiety intervention that will be acceptable to Veterans and feasible for PC-MHI&#xD;
      providers. The primary aim of the current study is to conduct a pilot randomized controlled&#xD;
      trial to evaluate feasibility, acceptability, potential implementation barriers and&#xD;
      facilitators, and effectiveness of the intervention compared to usual care.&#xD;
&#xD;
      Methods: This will be a pilot hybrid type I effectiveness-implementation randomized&#xD;
      controlled trial (N = 35). The primary goal is to evaluate feasibility, acceptability, and&#xD;
      effectiveness of the intervention in reducing anxiety symptom severity compared to usual&#xD;
      care. The secondary goal is to collect preliminary data on implementation barriers and&#xD;
      facilitators that may affect future real-world uptake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 17, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized clinical trial with randomization to the intervention condition or control condition</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder-7 at Post-Assessment</measure>
    <time_frame>Baseline &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 at Post-Assessment</measure>
    <time_frame>Baseline &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety Stress Scale-21 Anxiety Subscale Change</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety Stress Scale-21 Depression Subscale Change</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety Stress Scale-21 Stress Subscale Change</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Anxiety Severity and Impairment Scale Change</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Depression Severity and Impairment Scale Change</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment</measure>
    <time_frame>Baseline &amp; Post-Assessment (at 16 weeks)</time_frame>
    <description>Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Engagement in Treatment</measure>
    <time_frame>Post-assessment (16 weeks)</time_frame>
    <description>This feasibility outcome measure is the number who attended one or more treatment sessions</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Treatment Sessions Completed</measure>
    <time_frame>Post-assessment (16 weeks)</time_frame>
    <description>This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>Post-assessment (at 16 weeks)</time_frame>
    <description>The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Credibility</measure>
    <time_frame>Post-assessment (16 weeks)</time_frame>
    <description>The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility.</description>
  </other_outcome>
  <other_outcome>
    <measure>Therapeutic Alliance</measure>
    <time_frame>Post-assessment (16 weeks)</time_frame>
    <description>The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Brief anxiety intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual PC-MHI care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief anxiety intervention</intervention_name>
    <description>Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
    <arm_group_label>Brief anxiety intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual PC-MHI care</intervention_name>
    <description>Anxiety treatment with mental health provider in local primary care clinic</description>
    <arm_group_label>Usual PC-MHI care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Veteran seen in the Syracuse VA Medical Center primary care clinic in the past year&#xD;
&#xD;
          -  Screen positive for current (past 2 weeks) clinically significant anxiety symptoms (8&#xD;
             on Generalized Anxiety Disorder-7)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to communicate in English (as assessed by study staff)&#xD;
&#xD;
          -  Report or demonstrate hearing impairment that would preclude telephone screening (as&#xD;
             assessed by study staff)&#xD;
&#xD;
          -  Inability to demonstrate informed consent&#xD;
&#xD;
               -  defined as not being able to comprehend the study description as assessed by&#xD;
                  study staff and/or not being able to answer the comprehension of consent&#xD;
                  questions&#xD;
&#xD;
               -  have a diagnosis of dementia or severe cognitive impairment (defined by primary&#xD;
                  care provider or self-report, or having a diagnosis in Problem List)&#xD;
&#xD;
               -  screen positive for cognitive impairment (3 or more errors on cognitive screener)&#xD;
&#xD;
          -  Have a diagnosis of obsessive-compulsive disorder (OCD) or serious mental illness&#xD;
             (SMI) in Problem List&#xD;
&#xD;
               -  i.e., psychotic disorders, bipolar disorder&#xD;
&#xD;
          -  Have an encounter diagnosis of post-traumatic stress disorder (PTSD) within the past 2&#xD;
             years OR screen positive for PTSD (3 or more on PC-PTSD-5)&#xD;
&#xD;
          -  Currently in psychotherapy/counseling for anxiety and/or depression, defined as any of&#xD;
             the following within the past 30 days:&#xD;
&#xD;
               -  attending specialty mental health sessions [excluding a single intake session]&#xD;
&#xD;
               -  attending 2 or more Primary Care-Mental Health Integration sessions&#xD;
&#xD;
               -  Being hospitalized for mental health treatment&#xD;
&#xD;
          -  Report severe depressive symptoms (20 or more on Patient Health Questionnaire-9)&#xD;
&#xD;
          -  At imminent risk of suicide&#xD;
&#xD;
               -  defined as being identified as imminent risk based on study staff's suicide risk&#xD;
                  assessment [verified by the PI] and in need of intensive treatment&#xD;
&#xD;
               -  e.g., hospitalization] to ensure safety&#xD;
&#xD;
          -  Started or had dosage change in psychotropic medication for anxiety or depression in&#xD;
             the past 30 days&#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>Robyn L. Shepardson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syracuse VA Medical Center, Syracuse, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syracuse VA Medical Center, Syracuse, NY</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210-2716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <results_first_submitted>March 8, 2022</results_first_submitted>
  <results_first_submitted_qc>March 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 7, 2022</results_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>primary health care</keyword>
  <keyword>Veterans</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 and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03794089/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were adult (age 18 years or older) Veterans recruited from primary care clinics at the Syracuse VA Medical Center from April 2019 through October 2020. Eligible participants were identified through case finding from electronic medical records, direct referrals from primary care and behavioral health providers, or referrals from other local behavioral health research studies.</recruitment_details>
      <pre_assignment_details>A telephone eligibility screening identified those eligible to participate in the study, based on study eligibility criteria including endorsing current anxiety anxiety symptoms and not already being in psychotherapy for anxiety/depression.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Brief Anxiety Intervention</title>
          <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
        </group>
        <group group_id="P2">
          <title>Usual PC-MHI Care</title>
          <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 4-week Assessment</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 8-week Assessment</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 12-week Assessment</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </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="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled participants who completed the Baseline assessment</population>
      <group_list>
        <group group_id="B1">
          <title>Brief Anxiety Intervention</title>
          <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
        </group>
        <group group_id="B2">
          <title>Usual PC-MHI Care</title>
          <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="35"/>
          </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="49.29" spread="15.76"/>
                    <measurement group_id="B2" value="45.56" spread="16.88"/>
                    <measurement group_id="B3" value="47.37" spread="16.21"/>
                  </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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Generalized Anxiety Disorder-7</title>
          <description>Anxiety symptom severity was measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.76" spread="4.41"/>
                    <measurement group_id="B2" value="11.94" spread="3.00"/>
                    <measurement group_id="B3" value="12.34" spread="3.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Health Questionnaire-9</title>
          <description>Depressive symptom severity was measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.18" spread="4.54"/>
                    <measurement group_id="B2" value="10.78" spread="5.08"/>
                    <measurement group_id="B3" value="10.97" spread="4.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Generalized Anxiety Disorder-7 at Post-Assessment</title>
        <description>The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.</description>
        <time_frame>Baseline &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled participants who completed Post-Assessment at 16 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Generalized Anxiety Disorder-7 at Post-Assessment</title>
          <description>The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.</description>
          <population>Enrolled participants who completed Post-Assessment at 16 weeks</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="11"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GAD-7 total at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="4.2"/>
                    <measurement group_id="O2" value="12.0" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GAD-7 total at Post (16 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="5.2"/>
                    <measurement group_id="O2" value="9.1" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>comparisons of groups at post-assessment controls for baseline GAD-7 total scores</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.035</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health Questionnaire-9 at Post-Assessment</title>
        <description>The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.</description>
        <time_frame>Baseline &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled Participants who completed Post-Assessment at 16 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire-9 at Post-Assessment</title>
          <description>The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.</description>
          <population>Enrolled Participants who completed Post-Assessment at 16 weeks</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="11"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PHQ-9 total at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="5.0"/>
                    <measurement group_id="O2" value="10.8" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PHQ-9 total at Post (16 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="4.7"/>
                    <measurement group_id="O2" value="7.6" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>comparisons of groups at post-assessment controls for baseline PHQ-9 total scores</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.231</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Anxiety Stress Scale-21 Anxiety Subscale Change</title>
        <description>The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled participants who completed each assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Anxiety Stress Scale-21 Anxiety Subscale Change</title>
          <description>The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.</description>
          <population>Enrolled participants who completed each assessment</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="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DASS-21 Anxiety subscale total at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4" spread="9.4"/>
                    <measurement group_id="O2" value="10.1" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Anxiety subscale total at 4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="7.3"/>
                    <measurement group_id="O2" value="9.4" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Anxiety subscale total at 8 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="6.3"/>
                    <measurement group_id="O2" value="10.1" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Anxiety subscale total at 12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="4.7"/>
                    <measurement group_id="O2" value="9.9" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Anxiety subscale total at Post Assessment (16 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="5.0"/>
                    <measurement group_id="O2" value="9.6" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Anxiety subscale total from Baseline to 4 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.393</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.022</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.013</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.049</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Anxiety Stress Scale-21 Depression Subscale Change</title>
        <description>The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid.</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled participants who completed each assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Anxiety Stress Scale-21 Depression Subscale Change</title>
          <description>The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid.</description>
          <population>Enrolled participants who completed each assessment</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="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DASS-21 Depression subscale total at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="9.9"/>
                    <measurement group_id="O2" value="12.2" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Depression subscale total at 4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="5.6"/>
                    <measurement group_id="O2" value="11.1" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Depression subscale total at 8 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="4.8"/>
                    <measurement group_id="O2" value="11.9" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Depression subscale total at 12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="4.3"/>
                    <measurement group_id="O2" value="10.8" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Depression subscale total at Post-assessment (16 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="4.9"/>
                    <measurement group_id="O2" value="9.9" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Depression subscale total from Baseline to 4 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.008</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Depression subscale total from Baseline to 8 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Depression subscale total from Baseline to 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.008</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Anxiety Stress Scale-21 Stress Subscale Change</title>
        <description>The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled participants who completed each assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Anxiety Stress Scale-21 Stress Subscale Change</title>
          <description>The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.</description>
          <population>Enrolled participants who completed each assessment</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="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DASS-21 Stress subscale total at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.7" spread="8.6"/>
                    <measurement group_id="O2" value="17.8" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Stress subscale total at 4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" spread="8.0"/>
                    <measurement group_id="O2" value="17.3" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Stress subscale total at 8 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="6.9"/>
                    <measurement group_id="O2" value="17.0" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Stress subscale total at 12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="8.0"/>
                    <measurement group_id="O2" value="16.4" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DASS-21 Stress subscale total at Post-assessment (16 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="9.2"/>
                    <measurement group_id="O2" value="14.1" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Stress subscale total from Baseline to 4 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.440</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Stress subscale total from Baseline to 8 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.022</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Stress subscale total from Baseline to 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.032</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.091</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Anxiety Severity and Impairment Scale Change</title>
        <description>Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety.</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled participants who completed each assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Anxiety Severity and Impairment Scale Change</title>
          <description>Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety.</description>
          <population>Enrolled participants who completed each assessment</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="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>OASIS total at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="3.9"/>
                    <measurement group_id="O2" value="9.4" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OASIS total at 4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="3.3"/>
                    <measurement group_id="O2" value="8.2" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OASIS total at 8 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="3.4"/>
                    <measurement group_id="O2" value="8.0" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OASIS total at 12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="3.7"/>
                    <measurement group_id="O2" value="8.2" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OASIS total at Post-assessment (16 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="3.8"/>
                    <measurement group_id="O2" value="7.4" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in OASIS total score from Baseline to 4 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.058</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in OASIS total score from Baseline to 8 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.032</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in OASIS total score from Baseline to 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.007</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in OASIS total score from Baseline to Post assessment (16 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.044</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Depression Severity and Impairment Scale Change</title>
        <description>Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression.</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled participants who completed each assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Depression Severity and Impairment Scale Change</title>
          <description>Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression.</description>
          <population>Enrolled participants who completed each assessment</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="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ODSIS total at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="4.3"/>
                    <measurement group_id="O2" value="6.2" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ODSIS total at 4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="3.7"/>
                    <measurement group_id="O2" value="5.3" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ODSIS total at 8 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="3.5"/>
                    <measurement group_id="O2" value="5.6" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ODSIS total at 12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="3.3"/>
                    <measurement group_id="O2" value="6.2" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ODSIS total at Post-assessment (16 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="3.7"/>
                    <measurement group_id="O2" value="5.0" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in ODSIS total from Baseline to 4 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.328</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in ODSIS total from Baseline to 8 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.148</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in ODSIS total from Baseline to 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.002</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in ODSIS total from Baseline to Post-assessment (16 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing null hypothesis of no difference between groups</non_inferiority_desc>
            <p_value>0.069</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment</title>
        <description>Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life.</description>
        <time_frame>Baseline &amp; Post-Assessment (at 16 weeks)</time_frame>
        <population>Enrolled Participants who completed Post-Assessment at 16 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment</title>
          <description>Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life.</description>
          <population>Enrolled Participants who completed Post-Assessment at 16 weeks</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="11"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Q-LES-Q-SF total at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.9" spread="8.5"/>
                    <measurement group_id="O2" value="43.8" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q-LES-Q-SF total at Post (16 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.9" spread="8.1"/>
                    <measurement group_id="O2" value="48.7" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scores</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.928</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Engagement in Treatment</title>
        <description>This feasibility outcome measure is the number who attended one or more treatment sessions</description>
        <time_frame>Post-assessment (16 weeks)</time_frame>
        <population>All participants who enrolled in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Engagement in Treatment</title>
          <description>This feasibility outcome measure is the number who attended one or more treatment sessions</description>
          <population>All participants who enrolled in the study</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing null hypothesis of no difference between groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.402</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;.05</p_value_desc>
            <method>Fisher Exact</method>
            <method_desc>degrees of freedom = 1</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Treatment Sessions Completed</title>
        <description>This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase</description>
        <time_frame>Post-assessment (16 weeks)</time_frame>
        <population>All participants enrolled in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Sessions Completed</title>
          <description>This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase</description>
          <population>All participants enrolled in the study</population>
          <units>sessions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.2"/>
                    <measurement group_id="O2" value="1.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing the null hypothesis of no difference between groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=.05</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Satisfaction</title>
        <description>The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment.</description>
        <time_frame>Post-assessment (at 16 weeks)</time_frame>
        <population>All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction</title>
          <description>The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment.</description>
          <population>All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session</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="10"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.80" spread="2.82"/>
                    <measurement group_id="O2" value="24.23" spread="5.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing the null hypothesis of no difference between groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.006</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=.05</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>Used Satterthwaite method given unequal variances</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Credibility</title>
        <description>The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility.</description>
        <time_frame>Post-assessment (16 weeks)</time_frame>
        <population>All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Credibility</title>
          <description>The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility.</description>
          <population>All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session</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="10"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.20" spread="5.51"/>
                    <measurement group_id="O2" value="22.31" spread="11.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing the null hypothesis of no difference between groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=.05</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>used Satterthwaite method given unequal variances</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Therapeutic Alliance</title>
        <description>The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity.</description>
        <time_frame>Post-assessment (16 weeks)</time_frame>
        <population>All participants who completed Post-assessment (16 weeks) and reported attending at least one treatment session</population>
        <group_list>
          <group group_id="O1">
            <title>Brief Anxiety Intervention</title>
            <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
          </group>
          <group group_id="O2">
            <title>Usual PC-MHI Care</title>
            <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Therapeutic Alliance</title>
          <description>The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity.</description>
          <population>All participants who completed Post-assessment (16 weeks) and reported attending at least one treatment session</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="10"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.00" spread="5.54"/>
                    <measurement group_id="O2" value="42.62" spread="9.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing the null hypothesis of no difference between groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;=.05</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over the course of a participant's study participation, 16 weeks.</time_frame>
      <desc>n/a (same definitions as clinicaltrials.gov). Adverse event collection included systematic assessment (e.g., anxiety and depressive symptoms assessed at each treatment session in intervention condition and at each study assessment) and non-systematic assessment (e.g., participant self-report, information in participant medical record).</desc>
      <group_list>
        <group group_id="E1">
          <title>Brief Anxiety Intervention</title>
          <description>Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management&#xD;
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills</description>
        </group>
        <group group_id="E2">
          <title>Usual PC-MHI Care</title>
          <description>Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care&#xD;
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Participant was admitted to the hospital overnight for monitoring of a pre-existing medical condition that was unrelated to the treatment received in the study.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Symptom exacerbation</sub_title>
                <description>Clinically significant increase in anxiety and depression symptom severity from 2nd to 3rd intervention session. This was unrelated to the intervention or study, rather it was directly related to a psychosocial stressor (father unexpectedly died).</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This was a single-site pilot trial with a small sample size so results should be interpreted with caution. The attrition rate for assessments was slightly higher in the intervention (vs. comparison) condition. However, multi-level modeling analyses made use of all participant data provided. We did not have a follow-up assessment to examine whether treatment gains were maintained over time.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Robyn L. Shepardson</name_or_title>
      <organization>VA Center for Integrated Healthcare</organization>
      <phone>315-425-4400 ext 53956</phone>
      <email>Robyn.Shepardson@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/NCT03794089
org study id: CDX 18-006
nct id: NCT03794089
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Anxiety is common among primary care patients, but is undertreated. The purpose of this study
      is to evaluate whether a brief anxiety treatment designed for VA primary care is more
      effective at reducing anxiety symptoms in Veterans compared to usual care. The investigators
      will also examine whether Veterans like the brief treatment and whether the treatment can be
      feasibly delivered in primary care. Forty-eight adult Veteran primary care patients from the
      Syracuse VAMC who are experiencing anxiety symptoms will be recruited and randomly assigned
      to receive the brief anxiety treatment or usual care. The brief treatment consists of up to
      six 30-minute sessions with a cognitive-behavioral skills focus. The investigators will
      compare anxiety symptom severity between the two groups at baseline and at post-assessment 16
      weeks later.
Background/Rationale: Many Veteran primary care patients experience impairing symptoms of
      anxiety, but rates of treatment are low. Primary Care-Mental Health Integration (PC-MHI), in
      which mental health clinicians provide brief treatment in the primary care setting, can
      bridge the gap between demand for, and availability of, anxiety treatment. However, brief
      anxiety interventions suitable for use in the PC-MHI setting are needed. Developing an
      effective brief PC-MHI intervention for anxiety would address a gap in VA treatment options
      and facilitate high quality healthcare that improves treatment engagement, clinical outcomes,
      and patient experience. To ensure maximum reach, this intervention should accommodate a
      variety of subthreshold and diagnostic anxiety presentations, as well as comorbid depression.

      Objectives: The overall goal of this research program is to develop, refine, and evaluate a
      brief anxiety intervention that will be acceptable to Veterans and feasible for PC-MHI
      providers. The primary aim of the current study is to conduct a pilot randomized controlled
      trial to evaluate feasibility, acceptability, potential implementation barriers and
      facilitators, and effectiveness of the intervention compared to usual care.

      Methods: This will be a pilot hybrid type I effectiveness-implementation randomized
      controlled trial (N = 35). The primary goal is to evaluate feasibility, acceptability, and
      effectiveness of the intervention in reducing anxiety symptom severity compared to usual
      care. The secondary goal is to collect preliminary data on implementation barriers and
      facilitators that may affect future real-world uptake.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial with randomization to the intervention condition or control condition
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition
measure: Generalized Anxiety Disorder-7 at Post-Assessment
time frame: Baseline & Post-Assessment (at 16 weeks)
description: The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.
measure: Patient Health Questionnaire-9 at Post-Assessment
time frame: Baseline & Post-Assessment (at 16 weeks)
description: The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.
measure: Depression Anxiety Stress Scale-21 Anxiety Subscale Change
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
description: The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.
measure: Depression Anxiety Stress Scale-21 Depression Subscale Change
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
description: The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid.
measure: Depression Anxiety Stress Scale-21 Stress Subscale Change
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
description: The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.
measure: Overall Anxiety Severity and Impairment Scale Change
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
description: Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety.
measure: Overall Depression Severity and Impairment Scale Change
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
description: Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression.
measure: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment
time frame: Baseline & Post-Assessment (at 16 weeks)
description: Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life.
measure: Engagement in Treatment
time frame: Post-assessment (16 weeks)
description: This feasibility outcome measure is the number who attended one or more treatment sessions
measure: Number of Treatment Sessions Completed
time frame: Post-assessment (16 weeks)
description: This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase
measure: Treatment Satisfaction
time frame: Post-assessment (at 16 weeks)
description: The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment.
measure: Treatment Credibility
time frame: Post-assessment (16 weeks)
description: The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility.
measure: Therapeutic Alliance
time frame: Post-assessment (16 weeks)
description: The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity.
arm group label: Brief anxiety intervention
arm group type: Experimental
description: Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management
arm group label: Usual PC-MHI care
arm group type: Active Comparator
description: Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care
intervention type: Behavioral
intervention name: Brief anxiety intervention
description: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
arm group label: Brief anxiety intervention
intervention type: Behavioral
intervention name: Usual PC-MHI care
description: Anxiety treatment with mental health provider in local primary care clinic
arm group label: Usual PC-MHI care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robyn L. Shepardson, PhD
role: Principal Investigator
affiliation: Syracuse VA Medical Center, Syracuse, NY
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This was a single-site pilot trial with a small sample size so results should be interpreted with caution. The attrition rate for assessments was slightly higher in the intervention (vs. comparison) condition. However, multi-level modeling analyses made use of all participant data provided. We did not have a follow-up assessment to examine whether treatment gains were maintained over time.
point of contact: 