<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/NCT02223858</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 13-080</org_study_id>
    <nct_id>NCT02223858</nct_id>
  </id_info>
  <brief_title>Staying Positive With Arthritis Study</brief_title>
  <acronym>SPA</acronym>
  <official_title>Staying Positive: An Intervention to Reduce Osteoarthritis Pain Disparities</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>
      Arthritis is a painful, disabling condition that disproportionately affects African&#xD;
      Americans. Existing arthritis treatments yield only small to moderate improvements in pain&#xD;
      and are not effective at reducing racial disparities in arthritis pain. According to the&#xD;
      biopsychosocial model of pain, there is a need for novel interventions that target&#xD;
      psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence&#xD;
      from the field of psychology suggests that an intervention designed to develop a positive&#xD;
      mindset has the potential to improve pain and functioning and reduce racial disparities in&#xD;
      patients with arthritis. Interventions to foster a positive mindset have been developed for&#xD;
      clinical patient populations but have not yet been fully tested in patients with arthritis or&#xD;
      in Veterans, nor have their effects on racial differences in clinical outcomes been examined.&#xD;
      This study will address these gaps by testing the impact of an evidence-based positive&#xD;
      activities intervention on pain and functioning in African American and White Veterans with&#xD;
      knee arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Arthritis is a prevalent and disabling source of chronic pain for which African&#xD;
      Americans (AAs) bear a disproportionate burden. The purpose of this study is to test a&#xD;
      patient-centered, non-invasive intervention to improve pain outcomes and reduce disparities&#xD;
      in AA and White Veterans with knee arthritis. The intervention is designed to help Veterans&#xD;
      develop a positive mindset, the health benefits of which are well-documented.&#xD;
&#xD;
      Objectives: The primary aim of this study is to evaluate the impact of a positive&#xD;
      intervention on pain and physical functioning in AA and White Veterans with knee arthritis&#xD;
      through a randomized, controlled, clinical trial. It is hypothesized that patients randomized&#xD;
      to a positive activities (PA) intervention will experience improved pain and functioning&#xD;
      compared to patients randomized to an attention control (AC) program, and that these&#xD;
      improvements will be larger for AA than for WH Veterans. The secondary aim of this study is&#xD;
      to identify variables that mediate the effects of the PA intervention on pain and&#xD;
      functioning. It is hypothesized that the effects of the PA intervention will be mediated by&#xD;
      psychosocial variables known to be associated with arthritis outcomes or racial differences&#xD;
      in arthritis outcomes (e.g., depression, self-efficacy, pain coping, perceived&#xD;
      discrimination).&#xD;
&#xD;
      Methods: A randomized, controlled, 2-arm design will be used to compare the effects of a&#xD;
      6-week PA intervention with that of an AC program on pain and functioning at 1, 3, and&#xD;
      6-months post-intervention among AA and WH Veterans with knee arthritis. Approximately 180 AA&#xD;
      and 180 WH primary care patients with knee pain symptoms consistent with arthritis will be&#xD;
      recruited from participating VA medical centers following the original protocol. [Due to&#xD;
      accelerated recruitment of the original target sample, up to 240 additional primary care&#xD;
      patients with knee pain symptoms consistent with OA will be recruited from participating VA&#xD;
      medical centers using inclusion criteria that take into account original ICD-9 codes and&#xD;
      their corresponding ICD-10 codes. The additional patients (including some men and some women,&#xD;
      as resources allow) will be recruited to increase power to detect sex differences in&#xD;
      secondary analyses after the primary aims of the study have been achieved using the original&#xD;
      cohort.] Eligible participants will complete an in-person baseline assessment of study&#xD;
      outcomes, mediators, and control variables and be randomized to a 6-week PA or AC program.&#xD;
      The PA program consists of completing 6 at-home activities (1 per week) that have been shown&#xD;
      to increase positivity. The AC program consists of 6 affectively neutral activities. Both&#xD;
      groups will receive weekly telephone calls from trained interventionists to clarify&#xD;
      instructions for the next week's activity and assess completion of the previous week's&#xD;
      activity. Outcomes and proposed mediating variables will be assessed via telephone surveys at&#xD;
      1 month, 3 months, and 6 months post-intervention. Study outcomes include self-reported pain&#xD;
      and physical functioning as measured by the Western Ontario MacMaster Index. Hypothesized&#xD;
      mediators include depressive symptoms, positive/negative affect, satisfaction with life,&#xD;
      arthritis self-efficacy, pain coping, pain catastrophizing, perceived discrimination, global&#xD;
      stress, and social support. The intervention impact over time and by race (primary aim) will&#xD;
      be tested using linear mixed models that allow repeated measures on the continuous outcomes&#xD;
      for each participant and assess change in outcomes over time. A multiple mediator bootstrap&#xD;
      approach to assess whether the effect of the intervention is mediated by the hypothesized&#xD;
      mediators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2015</start_date>
  <completion_date type="Actual">November 9, 2017</completion_date>
  <primary_completion_date type="Actual">November 9, 2017</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Randomization will be at the patient level, stratified by study site and patient race, with a 1:1 allocation using random block sizes of 2, 4, 6, or 8.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The statistician will seal PA and AC program workbooks in envelopes following the randomization scheme. To blind participants and staff during the baseline assessment, staff will take the next sealed envelope in the sequence to each baseline visit, to be opened after a patient has consented and completed the baseline assessment. The study staff that complete the baseline visits will be unblinded once a participant's envelope is opened; participants will not be told whether they are in the PA or AC program. Staff who conduct the weekly intervention calls in the 6 weeks following the baseline visit will also be unblinded. To maintain blinding for the collection of outcome measures, study staff members who did not complete the baseline visit or any weekly calls during the 6-week program period for a given participant will collect the 1, 3, and 6-month follow-up assessments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention</measure>
    <time_frame>Baseline to 6 months post-intervention</time_frame>
    <description>Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention</measure>
    <time_frame>Baseline to 6 months post-intervention</time_frame>
    <description>Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention</measure>
    <time_frame>Baseline to 6 months post-intervention</time_frame>
    <description>Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Arthritis</condition>
  <arm_group>
    <arm_group_label>Positive Activities (PA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Positive Activities (PA) Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control (AC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Attention Control (AC) Program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Activities (PA) Program</intervention_name>
    <description>6-week program of at-home activities (1 per week) that have been shown to increase positivity. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.</description>
    <arm_group_label>Positive Activities (PA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control (AC) Program</intervention_name>
    <description>6-week program of at-home activities (1 per week) based on affectively neutral activities from control conditions in studies of positive activities interventions. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.</description>
    <arm_group_label>Attention Control (AC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The target population will be African American (AA) and White (WH) Veterans with&#xD;
        symptomatic knee arthritis. Specific inclusion criteria include:&#xD;
&#xD;
          -  Age 50 years or older&#xD;
&#xD;
          -  Receive primary care at a participating study site&#xD;
&#xD;
          -  Self-report as non-Hispanic black/AA or non-Hispanic WH&#xD;
&#xD;
          -  Frequent, symptomatic knee pain identified using questions from the OA Initiative&#xD;
&#xD;
          -  Pain level of 4 or higher on a 0-10 numeric rating scale&#xD;
&#xD;
          -  Can speak, read, and write in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they:&#xD;
&#xD;
          -  Report serious problems with hearing, eyesight, or memory&#xD;
&#xD;
          -  Report having been diagnosed any type of arthritis other than osteoarthritis or&#xD;
             degenerative arthritis&#xD;
&#xD;
          -  Report that they have been treated for cancer in the last 3 years&#xD;
&#xD;
          -  Report having had a steroid injection into one or both knees in the past 3 months&#xD;
&#xD;
          -  Report having had a knee replacement into one or both knees in the past 3 months&#xD;
&#xD;
          -  Report having plans to have a knee replacement in one or both knees in the next 6&#xD;
             months&#xD;
&#xD;
          -  Report that there is a reason they cannot complete the study procedures, which include&#xD;
             telephone calls and program activities that involve reading and writing&#xD;
&#xD;
          -  Do not have a telephone number where they can receive telephone calls from research&#xD;
             staff&#xD;
&#xD;
          -  Screen positive for cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leslie RM Hausmann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hausmann LRM, Ibrahim SA, Kwoh CK, Youk A, Obrosky DS, Weiner DK, Vina E, Gallagher RM, Mauro GT, Parks A. Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain. Contemp Clin Trials. 2018 Jan;64:243-253. doi: 10.1016/j.cct.2017.09.001. Epub 2017 Sep 8.</citation>
    <PMID>28893676</PMID>
  </reference>
  <reference>
    <citation>Hausmann LRM, Youk A, Kwoh CK, Ibrahim SA, Hannon MJ, Weiner DK, Gallagher RM, Parks A. Testing a Positive Psychological Intervention for Osteoarthritis. Pain Med. 2017 Oct 1;18(10):1908-1920. doi: 10.1093/pm/pnx141. Erratum In: Pain Med. 2017 Sep 1;18(9):1830.</citation>
    <PMID>29044408</PMID>
  </reference>
  <results_reference>
    <citation>Vina ER, Hausmann LRM, Obrosky DS, Youk A, Ibrahim SA, Weiner DK, Gallagher RM, Kwoh CK. Social &amp; psychological factors associated with oral analgesic use in knee osteoarthritis management. Osteoarthritis Cartilage. 2019 Jul;27(7):1018-1025. doi: 10.1016/j.joca.2019.01.010. Epub 2019 Feb 1.</citation>
    <PMID>30716537</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>September 20, 2018</results_first_submitted>
  <results_first_submitted_qc>September 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 11, 2019</results_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health Status Disparities</keyword>
  <keyword>Arthritis</keyword>
  <keyword>Psychology</keyword>
  <keyword>Pain Management</keyword>
  <keyword>Affect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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>May 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02223858/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02223858/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients with symptomatic knee OA from Veterans Affairs (VA) medical centers in Pittsburgh and Philadelphia, Pennsylvania, were recruited by mail and telephone. Mailings were sent to patients meeting basic eligibility criteria based on their VA medical records Recruitment for the study ran from July 2015 to February 2017.</recruitment_details>
      <pre_assignment_details>Eligible patients attended an in-person baseline visit where they provided written informed consent, completed a staff-administered baseline assessment, and were randomized to a 6-week positive psychological intervention or neutral control program.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Positive Activities (PA)</title>
          <description>Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).</description>
        </group>
        <group group_id="P2">
          <title>Attention Control (AC)</title>
          <description>Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="180"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>1-month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3-month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6-month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Positive Activities (PA)</title>
          <description>Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).</description>
        </group>
        <group group_id="B2">
          <title>Attention Control (AC)</title>
          <description>Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.</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="180"/>
            <count group_id="B2" value="180"/>
            <count group_id="B3" value="360"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="180"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="165"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="180"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="275"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="180"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                    <measurement group_id="B2" value="180"/>
                    <measurement group_id="B3" value="360"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="180"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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="90"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="180"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                    <measurement group_id="B2" value="180"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-reported pain, physical functioning, and global assessment of pain at baseline</title>
          <population>For Pain and Physical Functioning, those who skipped &gt;20% of items within a scale (&gt;1 or &gt;3 items, respectively) were excluded.&#xD;
*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Pain (Western Ontario McMaster Index;100=worst)*</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="179"/>
                    <count group_id="B2" value="178"/>
                    <count group_id="B3" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.24" spread="16.95"/>
                    <measurement group_id="B2" value="47.42" spread="18.07"/>
                    <measurement group_id="B3" value="48.83" spread="17.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical functioning (WOMAC; 100=worst)*</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="177"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.94" spread="17.73"/>
                    <measurement group_id="B2" value="45.70" spread="18.53"/>
                    <measurement group_id="B3" value="46.82" spread="18.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global assessment (0-10; higher=worse)*</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="180"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.13" spread="2.14"/>
                    <measurement group_id="B2" value="4.89" spread="1.96"/>
                    <measurement group_id="B3" value="5.01" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention</title>
        <description>Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.</description>
        <time_frame>Baseline to 6 months post-intervention</time_frame>
        <population>Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Activities (PA)</title>
            <description>Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).</description>
          </group>
          <group group_id="O2">
            <title>Attention Control (AC)</title>
            <description>Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention</title>
          <description>Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.</description>
          <population>Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.</population>
          <units>units 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="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                    <count group_id="O2" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.24" spread="16.95"/>
                    <measurement group_id="O2" value="47.42" spread="18.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.42" spread="18.58"/>
                    <measurement group_id="O2" value="43.57" spread="20.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.87" spread="19.16"/>
                    <measurement group_id="O2" value="43.32" spread="19.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.22" spread="20.97"/>
                    <measurement group_id="O2" value="41.59" spread="19.87"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.</non_inferiority_desc>
            <p_value>0.791</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>All models adjusted for site.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention</title>
        <description>Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.</description>
        <time_frame>Baseline to 6 months post-intervention</time_frame>
        <population>Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Activities (PA)</title>
            <description>Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).</description>
          </group>
          <group group_id="O2">
            <title>Attention Control (AC)</title>
            <description>Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention</title>
          <description>Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.</description>
          <population>Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.</population>
          <units>units 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="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.94" spread="17.73"/>
                    <measurement group_id="O2" value="45.70" spread="18.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.61" spread="19.81"/>
                    <measurement group_id="O2" value="43.08" spread="20.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.39" spread="19.01"/>
                    <measurement group_id="O2" value="43.32" spread="19.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.89" spread="20.02"/>
                    <measurement group_id="O2" value="41.91" spread="20.00"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.</non_inferiority_desc>
            <p_value>0.880</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>All models adjusted for site.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention</title>
        <description>Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain.</description>
        <time_frame>Baseline to 6 months post-intervention</time_frame>
        <population>Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs from the overall number analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Activities (PA)</title>
            <description>Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).</description>
          </group>
          <group group_id="O2">
            <title>Attention Control (AC)</title>
            <description>Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention</title>
          <description>Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain.</description>
          <population>Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs from the overall number analyzed.</population>
          <units>units 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="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.13" spread="2.14"/>
                    <measurement group_id="O2" value="4.89" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="2.16"/>
                    <measurement group_id="O2" value="4.71" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.83" spread="2.10"/>
                    <measurement group_id="O2" value="4.69" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.82" spread="2.27"/>
                    <measurement group_id="O2" value="4.60" spread="2.24"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.</non_inferiority_desc>
            <p_value>0.901</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>All models adjusted for site.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline through 6-months post intervention.</time_frame>
      <desc>All adverse events that occurred with the participants fell under the definition of &quot;serious adverse events&quot; as they were all hospitalizations. There are no &quot;other (not including serious) adverse events&quot; to report.</desc>
      <group_list>
        <group group_id="E1">
          <title>Positive Activities (PA)</title>
          <description>Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).</description>
        </group>
        <group group_id="E2">
          <title>Attention Control (AC)</title>
          <description>Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.</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="1" subjects_at_risk="180"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="180"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations unrelated to the study</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Included patients with knee osteoarthritis from 2 VA medical centers; did not assess pain conditions other than arthritis; adherence and outcomes were self-reported.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Leslie R.M. Hausmann</name_or_title>
      <organization>Veterans Affairs Pittsburgh Healthcare System</organization>
      <phone>412-360-2112</phone>
      <email>leslie.hausmann@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/NCT02223858
org study id: IIR 13-080
nct id: NCT02223858
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Arthritis is a painful, disabling condition that disproportionately affects African
      Americans. Existing arthritis treatments yield only small to moderate improvements in pain
      and are not effective at reducing racial disparities in arthritis pain. According to the
      biopsychosocial model of pain, there is a need for novel interventions that target
      psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence
      from the field of psychology suggests that an intervention designed to develop a positive
      mindset has the potential to improve pain and functioning and reduce racial disparities in
      patients with arthritis. Interventions to foster a positive mindset have been developed for
      clinical patient populations but have not yet been fully tested in patients with arthritis or
      in Veterans, nor have their effects on racial differences in clinical outcomes been examined.
      This study will address these gaps by testing the impact of an evidence-based positive
      activities intervention on pain and functioning in African American and White Veterans with
      knee arthritis.
Background: Arthritis is a prevalent and disabling source of chronic pain for which African
      Americans (AAs) bear a disproportionate burden. The purpose of this study is to test a
      patient-centered, non-invasive intervention to improve pain outcomes and reduce disparities
      in AA and White Veterans with knee arthritis. The intervention is designed to help Veterans
      develop a positive mindset, the health benefits of which are well-documented.

      Objectives: The primary aim of this study is to evaluate the impact of a positive
      intervention on pain and physical functioning in AA and White Veterans with knee arthritis
      through a randomized, controlled, clinical trial. It is hypothesized that patients randomized
      to a positive activities (PA) intervention will experience improved pain and functioning
      compared to patients randomized to an attention control (AC) program, and that these
      improvements will be larger for AA than for WH Veterans. The secondary aim of this study is
      to identify variables that mediate the effects of the PA intervention on pain and
      functioning. It is hypothesized that the effects of the PA intervention will be mediated by
      psychosocial variables known to be associated with arthritis outcomes or racial differences
      in arthritis outcomes (e.g., depression, self-efficacy, pain coping, perceived
      discrimination).

      Methods: A randomized, controlled, 2-arm design will be used to compare the effects of a
      6-week PA intervention with that of an AC program on pain and functioning at 1, 3, and
      6-months post-intervention among AA and WH Veterans with knee arthritis. Approximately 180 AA
      and 180 WH primary care patients with knee pain symptoms consistent with arthritis will be
      recruited from participating VA medical centers following the original protocol. [Due to
      accelerated recruitment of the original target sample, up to 240 additional primary care
      patients with knee pain symptoms consistent with OA will be recruited from participating VA
      medical centers using inclusion criteria that take into account original ICD-9 codes and
      their corresponding ICD-10 codes. The additional patients (including some men and some women,
      as resources allow) will be recruited to increase power to detect sex differences in
      secondary analyses after the primary aims of the study have been achieved using the original
      cohort.] Eligible participants will complete an in-person baseline assessment of study
      outcomes, mediators, and control variables and be randomized to a 6-week PA or AC program.
      The PA program consists of completing 6 at-home activities (1 per week) that have been shown
      to increase positivity. The AC program consists of 6 affectively neutral activities. Both
      groups will receive weekly telephone calls from trained interventionists to clarify
      instructions for the next week's activity and assess completion of the previous week's
      activity. Outcomes and proposed mediating variables will be assessed via telephone surveys at
      1 month, 3 months, and 6 months post-intervention. Study outcomes include self-reported pain
      and physical functioning as measured by the Western Ontario MacMaster Index. Hypothesized
      mediators include depressive symptoms, positive/negative affect, satisfaction with life,
      arthritis self-efficacy, pain coping, pain catastrophizing, perceived discrimination, global
      stress, and social support. The intervention impact over time and by race (primary aim) will
      be tested using linear mixed models that allow repeated measures on the continuous outcomes
      for each participant and assess change in outcomes over time. A multiple mediator bootstrap
      approach to assess whether the effect of the intervention is mediated by the hypothesized
      mediators.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Randomization will be at the patient level, stratified by study site and patient race, with a 1:1 allocation using random block sizes of 2, 4, 6, or 8.
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
masking description: The statistician will seal PA and AC program workbooks in envelopes following the randomization scheme. To blind participants and staff during the baseline assessment, staff will take the next sealed envelope in the sequence to each baseline visit, to be opened after a patient has consented and completed the baseline assessment. The study staff that complete the baseline visits will be unblinded once a participant's envelope is opened; participants will not be told whether they are in the PA or AC program. Staff who conduct the weekly intervention calls in the 6 weeks following the baseline visit will also be unblinded. To maintain blinding for the collection of outcome measures, study staff members who did not complete the baseline visit or any weekly calls during the 6-week program period for a given participant will collect the 1, 3, and 6-month follow-up assessments.
measure: Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
time frame: Baseline to 6 months post-intervention
description: Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.
measure: Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
time frame: Baseline to 6 months post-intervention
description: Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.
measure: Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention
time frame: Baseline to 6 months post-intervention
description: Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain.
arm group label: Positive Activities (PA)
arm group type: Experimental
description: Positive Activities (PA) Program
arm group label: Attention Control (AC)
arm group type: Active Comparator
description: Attention Control (AC) Program
intervention type: Behavioral
intervention name: Positive Activities (PA) Program
description: 6-week program of at-home activities (1 per week) that have been shown to increase positivity. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
arm group label: Positive Activities (PA)
intervention type: Behavioral
intervention name: Attention Control (AC) Program
description: 6-week program of at-home activities (1 per week) based on affectively neutral activities from control conditions in studies of positive activities interventions. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
arm group label: Attention Control (AC)
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Leslie RM Hausmann, PhD
role: Principal Investigator
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
facility: 
facility: 
country: United States
citation: Hausmann LRM, Ibrahim SA, Kwoh CK, Youk A, Obrosky DS, Weiner DK, Vina E, Gallagher RM, Mauro GT, Parks A. Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain. Contemp Clin Trials. 2018 Jan;64:243-253. doi: 10.1016/j.cct.2017.09.001. Epub 2017 Sep 8.
PMID: 28893676
citation: Hausmann LRM, Youk A, Kwoh CK, Ibrahim SA, Hannon MJ, Weiner DK, Gallagher RM, Parks A. Testing a Positive Psychological Intervention for Osteoarthritis. Pain Med. 2017 Oct 1;18(10):1908-1920. doi: 10.1093/pm/pnx141. Erratum In: Pain Med. 2017 Sep 1;18(9):1830.
PMID: 29044408
citation: Vina ER, Hausmann LRM, Obrosky DS, Youk A, Ibrahim SA, Weiner DK, Gallagher RM, Kwoh CK. Social & psychological factors associated with oral analgesic use in knee osteoarthritis management. Osteoarthritis Cartilage. 2019 Jul;27(7):1018-1025. doi: 10.1016/j.joca.2019.01.010. Epub 2019 Feb 1.
PMID: 30716537
responsible party type: Sponsor
mesh term: Arthritis
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Included patients with knee osteoarthritis from 2 VA medical centers; did not assess pain conditions other than arthritis; adherence and outcomes were self-reported.
point of contact: 