<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/NCT02262377</url>
  </required_header>
  <id_info>
    <org_study_id>H-33096</org_study_id>
    <nct_id>NCT02262377</nct_id>
  </id_info>
  <brief_title>Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression</brief_title>
  <acronym>IMGV</acronym>
  <official_title>Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression in a Disparate Urban Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV)&#xD;
      are effective for treating patients with chronic pain and depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a randomized controlled comparative effectiveness trial for&#xD;
      patients from predominantly low-income minority backgrounds with chronic pain and depressive&#xD;
      symptoms comparing two treatment groups: (1) A standardized, 9-session Integrative Medicine&#xD;
      Group Visits (IMGV) protocol; (2) primary care visits including medications and provider's&#xD;
      advice. The trial will take place at three sites: Boston Medical Center's Family Medicine&#xD;
      Center and two affiliated federally qualified community health centers.&#xD;
&#xD;
      Patients at the three sites can self-refer or with their permission, their clinician can&#xD;
      forward their information via email, an electronic flag or phone call to research staff.&#xD;
      Following verbal consent, patients will be screened for eligibility by a Research Assistant&#xD;
      either over the phone or in person. Eligible participants will then have the study explained&#xD;
      to them by the Research Assistant and will be offered an opportunity to ask questions about&#xD;
      the study and then invited to provide informed consent. Those participants who consent to&#xD;
      participate will provide contact information for themselves and two additional contacts to&#xD;
      assist with follow-up. They will then complete the baseline data survey which will consist of&#xD;
      questionnaires on topics such as stress, pain, sleep, self-efficacy, social support, diet,&#xD;
      exercise, relaxation, and use of pain medications. These will be administered on a tablet by&#xD;
      a Research Assistant and should take no more than one hour to complete. Once the baseline&#xD;
      measures have been completed, participants will be randomized to either the intervention or&#xD;
      control condition. Once randomized, participants' clinicians will be notified via phone call,&#xD;
      letter or email that their patient is enrolled in the study.&#xD;
&#xD;
      INTERVENTION GROUP Integrative Medicine Group Visits (IMGV)&#xD;
&#xD;
      The intervention is adapted from Mindfulness Based Stress Reduction (MBSR). For this study,&#xD;
      those randomized to the intervention group will be asked to attend nine consecutive group&#xD;
      visits (once a week) and a follow-up group visit at 12 weeks after the last session. During&#xD;
      the session, a physician and co-leader facilitate each groups. Participants are taught and&#xD;
      practice relaxation techniques at each class. The physician facilitates a discussion on&#xD;
      health topics important to the group participants on chronic disease management, such as&#xD;
      prevention and management of pain and associated conditions (stress re-activity, insomnia,&#xD;
      obesity, hypertension etc.). Patients are also introduced to evidenced based complementary&#xD;
      activities such as self-massage techniques, acupressure, and cooking classes. Finally, an&#xD;
      optional healthy meal is served each week, creating an opportunity to model healthy nutrition&#xD;
      and build community. Individuals randomized to IMGV will continue to receive routine medical&#xD;
      care, including pain medications, from their primary care providers (PCPs).&#xD;
&#xD;
      Individual time spent with the group visit physician - Depending on the individual patient&#xD;
      and his/her needs. The IMGV physician facilitator will communicate with the participants'&#xD;
      PCPs (via electronic medical record or phone) throughout the intervention to give updates on&#xD;
      the activities and progress of the patients.&#xD;
&#xD;
      To establish the internal validity of IMGV a research assistant will monitor the groups. An&#xD;
      evaluation checklist of key components of the group visit will be used to assure internal&#xD;
      validity and standardization of group IMGV curriculum across all three sites.&#xD;
&#xD;
      COMPANION WEB-BASED HOMEWORK/ HOME PRACTICE&#xD;
&#xD;
      The website serves several functions: 1) by putting all the patient materials online, it&#xD;
      gives all patients regardless of study site the opportunity to track their health progress,&#xD;
      participate in a monitored discussion group, and have access to audio and visual materials&#xD;
      from class. At home, participants will complete their homework online which includes:&#xD;
      accessing video or audio exercises or watching provider talks, which reinforce key content&#xD;
      from the groups. 2) Our research team will use the website to track the length of time and&#xD;
      frequency that patients practice self-care exercises at home, as well as which portions of&#xD;
      the site the participant visits. Another component of the website is access to a Virtual&#xD;
      Patient Advocate (VPA). The VPA will deliver a menu of mind-body activities and nutrition&#xD;
      advice that mirrors the content of the IMGV groups.&#xD;
&#xD;
      Intervention participants will receive reminder calls each week prior to their IMGV from&#xD;
      study staff, just as they would for other medical visits. If a participant does not attend an&#xD;
      IMGV session, a research assistant will call to find out why they have missed the session and&#xD;
      to remind them of the importance of attending as many sessions as possible. They will also&#xD;
      receive letters/emails to remind them to log in to the website on a weekly basis and a&#xD;
      letter/email to remind them about the final, follow-up session.&#xD;
&#xD;
      Control Group&#xD;
&#xD;
      Patients randomized to the control group will be given access to IMGV if desired in a&#xD;
      non-study context at the completion of their data collection at 21 weeks (i.e., wait list&#xD;
      control). Access to primary care providers is our control group (an approximately 15-minute&#xD;
      usual care visit with MD, nurse practitioner (NP), physician assistant (PA) - prescribing&#xD;
      medications, advice, standard of care recommendations).&#xD;
&#xD;
      Nine weeks after study enrollment control participants will receive a request to complete a&#xD;
      follow-up survey which will measure the same items as the baseline survey with the exception&#xD;
      of the demographic information and health literacy information. Finally, 21 weeks after study&#xD;
      enrollment for the controls, participants will be asked to complete a second follow-up&#xD;
      survey. Both follow-up surveys will be administered on a tablet by a research assistant,&#xD;
      preferably in person, but by phone if a participant prefers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chronic Pain</measure>
    <time_frame>This was conducted at 21 weeks.</time_frame>
    <description>Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>This was conducted at 21 weeks.</time_frame>
    <description>Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Self Efficacy Scale</measure>
    <time_frame>This was conducted at 21 weeks.</time_frame>
    <description>Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Medication Use</measure>
    <time_frame>This was conducted at 21 weeks.</time_frame>
    <description>Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency Department Use</measure>
    <time_frame>This was collected at 21 weeks.</time_frame>
    <description>Number of emergency room visits based on chart review data collection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Integrative Medicine Group Visits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>primary care visits, which include medications and advice</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrative Medicine Group Visits</intervention_name>
    <description>Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.</description>
    <arm_group_label>Integrative Medicine Group Visits</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self-reported chronic pain for at least 12 weeks&#xD;
&#xD;
          -  average pain intensity for the previous week &gt;4 on a 0 to 10 numerical rating scale;&#xD;
             PHQ-9 score &gt;5, indicating minor depression or greater&#xD;
&#xD;
          -  English fluency sufficient to follow treatment instructions and answer survey&#xD;
             questions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous participation in IMGV&#xD;
&#xD;
          -  new pain treatments in past month or anticipated to begin in next 3 months&#xD;
&#xD;
          -  active or planned worker's compensation, disability, or personal injury claims&#xD;
&#xD;
          -  known or planned pregnancy&#xD;
&#xD;
          -  manic symptoms&#xD;
&#xD;
          -  active suicidality&#xD;
&#xD;
          -  psychotic symptoms&#xD;
&#xD;
          -  no PCP&#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>Paula Gardiner, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pcori.org/research-results/2013/integrative-medicine-group-visits-patient-centered-approach-reducing-chronic</url>
    <description>Description From the Patient-Centered Outcomes Research Institute website</description>
  </link>
  <reference>
    <citation>Upshur CC, Luckmann RS, Savageau JA. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med. 2006 Jun;21(6):652-5. doi: 10.1111/j.1525-1497.2006.00412.x.</citation>
    <PMID>16808752</PMID>
  </reference>
  <reference>
    <citation>Niazi AK, Niazi SK. Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. N Am J Med Sci. 2011 Jan;3(1):20-3. doi: 10.4297/najms.2011.320.</citation>
    <PMID>22540058</PMID>
  </reference>
  <reference>
    <citation>Cramer H, Lauche R, Paul A, Dobos G. Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Curr Oncol. 2012 Oct;19(5):e343-52. doi: 10.3747/co.19.1016.</citation>
    <PMID>23144582</PMID>
  </reference>
  <reference>
    <citation>Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.</citation>
    <PMID>23009599</PMID>
  </reference>
  <reference>
    <citation>Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.</citation>
    <PMID>21534932</PMID>
  </reference>
  <reference>
    <citation>Carnes D, Homer KE, Miles CL, Pincus T, Underwood M, Rahman A, Taylor SJ. Effective delivery styles and content for self-management interventions for chronic musculoskeletal pain: a systematic literature review. Clin J Pain. 2012 May;28(4):344-54. doi: 10.1097/AJP.0b013e31822ed2f3.</citation>
    <PMID>22001667</PMID>
  </reference>
  <reference>
    <citation>Eisenstat SA, Ulman K, Siegel AL, Carlson K. Diabetes group visits: integrated medical care and behavioral support to improve diabetes care and outcomes from a primary care perspective. Curr Diab Rep. 2013 Apr;13(2):177-87. doi: 10.1007/s11892-012-0349-5.</citation>
    <PMID>23207990</PMID>
  </reference>
  <results_reference>
    <citation>Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.</citation>
    <PMID>25105072</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>November 8, 2017</results_first_submitted>
  <results_first_submitted_qc>August 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 28, 2019</results_first_posted>
  <last_update_submitted>August 11, 2019</last_update_submitted>
  <last_update_submitted_qc>August 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Group Medical Visits</keyword>
  <keyword>Integrative Medicine</keyword>
  <keyword>Chronic Pain</keyword>
  <keyword>Depression</keyword>
  <keyword>MBSR</keyword>
  <keyword>Mindfulness Based Stress Reduction</keyword>
  <keyword>Web based</keyword>
  <keyword>Virtual Patient Advocate</keyword>
  <keyword>Internet Based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Integrative Medical Group Visits</title>
          <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting&#xD;
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>primary care visits, which include medications and advice</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="6"/>
              </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="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Found ineligible after enrollment</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>*We did not include intervention data on the four participants who withdrew consent.</population>
      <group_list>
        <group group_id="B1">
          <title>Integrative Medical Group Visits</title>
          <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting&#xD;
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>primary care visits, which include medications and advice</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="76"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="155"/>
          </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="50" spread="12.2"/>
                    <measurement group_id="B2" value="51" spread="12.4"/>
                    <measurement group_id="B3" value="50.5" spread="12.3"/>
                  </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="64"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </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="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="133"/>
                  </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="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="44"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Study Sites</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Boston Medical Center</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dotwell Health Center</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Codman Square Health Center</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less than $5K</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$5K-$29.99K</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$30K and over</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refused/ DK/ No income</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Work Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Full/ Part time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Retired/ Homemaker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sick Leave/ Disability</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education Level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; High school/ some HS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college/ AA degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College degree or higher</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>REALM-R score</title>
          <description>Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) is a word recognition test consisting of 11 items used to identify people at risk for poor literacy skills (Bass et al, 2003). Scores range from 0-8, and those with a score of 6 or less should be considered to be at risk for poor health literacy. You receive a point for every word pronounced properly.</description>
          <units>unit a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" spread="2.5"/>
                    <measurement group_id="B2" value="6" spread="2.5"/>
                    <measurement group_id="B3" value="6" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self Reported Substance Abuse</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Current Smoker ONLY</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 or more alcoholic drinks on one occasion only</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Illegal drug use only</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None - smoke, drink, or use illegal drug</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>use at-leas 2 cigarettes or alcohol, illegal drug</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Chronic Pain</title>
        <description>Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.</description>
        <time_frame>This was conducted at 21 weeks.</time_frame>
        <population>Intention to Treat Analysis Results</population>
        <group_list>
          <group group_id="O1">
            <title>Integrative Medicine Group Visits</title>
            <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care-Control</title>
            <description>Routine primary care visits, which include medications and advice</description>
          </group>
        </group_list>
        <measure>
          <title>Chronic Pain</title>
          <description>Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.</description>
          <population>Intention to Treat Analysis Results</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="68"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>21 week Average pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.0"/>
                    <measurement group_id="O2" value="6.0" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>21 week BPI Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.7"/>
                    <measurement group_id="O2" value="5.0" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>21 week BPI Severity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.3"/>
                    <measurement group_id="O2" value="6.0" spread="2.0"/>
                  </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>Intention to Treat Analysis for average chronic pain.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The ITT analysis was done for 21 week average pain.</non_inferiority_desc>
            <p_value>0.68</p_value>
            <p_value_desc>Statistical significance was set at p&lt; 0.05.</p_value_desc>
            <method>Regression, Poisson</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
          <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>The ITT analysis was done for 21 week BPI Interference.</non_inferiority_desc>
            <p_value>0.36</p_value>
            <p_value_desc>Statistical significance was set at p&lt; 0.05.</p_value_desc>
            <method>Regression, Poisson</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <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>The ITT analysis was done for 21 week BPI Severity.</non_inferiority_desc>
            <p_value>0.996</p_value>
            <p_value_desc>Statistical significance was set at p&lt; 0.05.</p_value_desc>
            <method>Regression, Poisson</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Depression</title>
        <description>Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.</description>
        <time_frame>This was conducted at 21 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integrative Medicine Group Visits</title>
            <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care-Control</title>
            <description>Routine primary care visits, which include medications and advice</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.</description>
          <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="68"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.32" spread="5.42"/>
                    <measurement group_id="O2" value="10.15" spread="5.88"/>
                  </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>
            <p_value>0.054</p_value>
            <method>Regression, Poisson</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Self Efficacy Scale</title>
        <description>Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.</description>
        <time_frame>This was conducted at 21 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integrative Medicine Group Visits</title>
            <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care-Control</title>
            <description>Routine primary care visits, which include medications and advice</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Self Efficacy Scale</title>
          <description>Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.</description>
          <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="68"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" spread="14.7"/>
                    <measurement group_id="O2" value="38" spread="13.5"/>
                  </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>
            <p_value>0.98</p_value>
            <method>Regression, Poisson</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Medication Use</title>
        <description>Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.</description>
        <time_frame>This was conducted at 21 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integrative Medicine Group Visits</title>
            <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care-Control</title>
            <description>Routine primary care visits, which include medications and advice</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Medication Use</title>
          <description>Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="60"/>
                  </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>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Emergency Department Use</title>
        <description>Number of emergency room visits based on chart review data collection.</description>
        <time_frame>This was collected at 21 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integrative Medicine Group Visits</title>
            <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care-Control</title>
            <description>Routine primary care visits, which include medications and advice</description>
          </group>
        </group_list>
        <measure>
          <title>Emergency Department Use</title>
          <description>Number of emergency room visits based on chart review data collection.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </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>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Integrative Medical Group Visits</title>
          <description>9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting&#xD;
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>primary care visits, which include medications and advice</description>
        </group>
        <group group_id="E3">
          <title>All Participants</title>
          <description>All participants included in the RCT.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization unrelated to study</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Non Serious Adverse</default_vocab>
        <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="19" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non Serious Adverse Events</sub_title>
                <description>Muscle Strain, pain in new location, ER visits, fell off chair, falling down, other.These adverse event terms cannot be separated.</description>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="76"/>
                <counts group_id="E2" events="20" subjects_affected="13" subjects_at_risk="79"/>
                <counts group_id="E3" events="42" subjects_affected="32" subjects_at_risk="155"/>
              </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>Our limitations for this study includes: study participation (intervention group did not all attend IMGV and not everyone in control group attended PCP visit), no data on baseline antidepressants medication, only English speaking patients included.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Paula Gardiner</name_or_title>
      <organization>Boston Medical Center</organization>
      <phone>414-6267 ext 617</phone>
      <email>Paula.GardinerMD@gmail.com</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/NCT02262377
org study id: H-33096
nct id: NCT02262377
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV)
      are effective for treating patients with chronic pain and depression.
The investigators propose a randomized controlled comparative effectiveness trial for
      patients from predominantly low-income minority backgrounds with chronic pain and depressive
      symptoms comparing two treatment groups: (1) A standardized, 9-session Integrative Medicine
      Group Visits (IMGV) protocol; (2) primary care visits including medications and provider's
      advice. The trial will take place at three sites: Boston Medical Center's Family Medicine
      Center and two affiliated federally qualified community health centers.

      Patients at the three sites can self-refer or with their permission, their clinician can
      forward their information via email, an electronic flag or phone call to research staff.
      Following verbal consent, patients will be screened for eligibility by a Research Assistant
      either over the phone or in person. Eligible participants will then have the study explained
      to them by the Research Assistant and will be offered an opportunity to ask questions about
      the study and then invited to provide informed consent. Those participants who consent to
      participate will provide contact information for themselves and two additional contacts to
      assist with follow-up. They will then complete the baseline data survey which will consist of
      questionnaires on topics such as stress, pain, sleep, self-efficacy, social support, diet,
      exercise, relaxation, and use of pain medications. These will be administered on a tablet by
      a Research Assistant and should take no more than one hour to complete. Once the baseline
      measures have been completed, participants will be randomized to either the intervention or
      control condition. Once randomized, participants' clinicians will be notified via phone call,
      letter or email that their patient is enrolled in the study.

      INTERVENTION GROUP Integrative Medicine Group Visits (IMGV)

      The intervention is adapted from Mindfulness Based Stress Reduction (MBSR). For this study,
      those randomized to the intervention group will be asked to attend nine consecutive group
      visits (once a week) and a follow-up group visit at 12 weeks after the last session. During
      the session, a physician and co-leader facilitate each groups. Participants are taught and
      practice relaxation techniques at each class. The physician facilitates a discussion on
      health topics important to the group participants on chronic disease management, such as
      prevention and management of pain and associated conditions (stress re-activity, insomnia,
      obesity, hypertension etc.). Patients are also introduced to evidenced based complementary
      activities such as self-massage techniques, acupressure, and cooking classes. Finally, an
      optional healthy meal is served each week, creating an opportunity to model healthy nutrition
      and build community. Individuals randomized to IMGV will continue to receive routine medical
      care, including pain medications, from their primary care providers (PCPs).

      Individual time spent with the group visit physician - Depending on the individual patient
      and his/her needs. The IMGV physician facilitator will communicate with the participants'
      PCPs (via electronic medical record or phone) throughout the intervention to give updates on
      the activities and progress of the patients.

      To establish the internal validity of IMGV a research assistant will monitor the groups. An
      evaluation checklist of key components of the group visit will be used to assure internal
      validity and standardization of group IMGV curriculum across all three sites.

      COMPANION WEB-BASED HOMEWORK/ HOME PRACTICE

      The website serves several functions: 1) by putting all the patient materials online, it
      gives all patients regardless of study site the opportunity to track their health progress,
      participate in a monitored discussion group, and have access to audio and visual materials
      from class. At home, participants will complete their homework online which includes:
      accessing video or audio exercises or watching provider talks, which reinforce key content
      from the groups. 2) Our research team will use the website to track the length of time and
      frequency that patients practice self-care exercises at home, as well as which portions of
      the site the participant visits. Another component of the website is access to a Virtual
      Patient Advocate (VPA). The VPA will deliver a menu of mind-body activities and nutrition
      advice that mirrors the content of the IMGV groups.

      Intervention participants will receive reminder calls each week prior to their IMGV from
      study staff, just as they would for other medical visits. If a participant does not attend an
      IMGV session, a research assistant will call to find out why they have missed the session and
      to remind them of the importance of attending as many sessions as possible. They will also
      receive letters/emails to remind them to log in to the website on a weekly basis and a
      letter/email to remind them about the final, follow-up session.

      Control Group

      Patients randomized to the control group will be given access to IMGV if desired in a
      non-study context at the completion of their data collection at 21 weeks (i.e., wait list
      control). Access to primary care providers is our control group (an approximately 15-minute
      usual care visit with MD, nurse practitioner (NP), physician assistant (PA) - prescribing
      medications, advice, standard of care recommendations).

      Nine weeks after study enrollment control participants will receive a request to complete a
      follow-up survey which will measure the same items as the baseline survey with the exception
      of the demographic information and health literacy information. Finally, 21 weeks after study
      enrollment for the controls, participants will be asked to complete a second follow-up
      survey. Both follow-up surveys will be administered on a tablet by a research assistant,
      preferably in person, but by phone if a participant prefers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Chronic Pain
time frame: This was conducted at 21 weeks.
description: Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.
measure: Depression
time frame: This was conducted at 21 weeks.
description: Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.
measure: Pain Self Efficacy Scale
time frame: This was conducted at 21 weeks.
description: Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.
measure: Pain Medication Use
time frame: This was conducted at 21 weeks.
description: Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.
measure: Emergency Department Use
time frame: This was collected at 21 weeks.
description: Number of emergency room visits based on chart review data collection.
arm group label: Integrative Medicine Group Visits
arm group type: Experimental
description: 9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
arm group label: Standard of Care
arm group type: No Intervention
description: primary care visits, which include medications and advice
intervention type: Behavioral
intervention name: Integrative Medicine Group Visits
description: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
arm group label: Integrative Medicine Group Visits
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paula Gardiner, MD, MPH
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
url: http://www.pcori.org/research-results/2013/integrative-medicine-group-visits-patient-centered-approach-reducing-chronic
description: Description From the Patient-Centered Outcomes Research Institute website
citation: Upshur CC, Luckmann RS, Savageau JA. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med. 2006 Jun;21(6):652-5. doi: 10.1111/j.1525-1497.2006.00412.x.
PMID: 16808752
citation: Niazi AK, Niazi SK. Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. N Am J Med Sci. 2011 Jan;3(1):20-3. doi: 10.4297/najms.2011.320.
PMID: 22540058
citation: Cramer H, Lauche R, Paul A, Dobos G. Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Curr Oncol. 2012 Oct;19(5):e343-52. doi: 10.3747/co.19.1016.
PMID: 23144582
citation: Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.
PMID: 23009599
citation: Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.
PMID: 21534932
citation: Carnes D, Homer KE, Miles CL, Pincus T, Underwood M, Rahman A, Taylor SJ. Effective delivery styles and content for self-management interventions for chronic musculoskeletal pain: a systematic literature review. Clin J Pain. 2012 May;28(4):344-54. doi: 10.1097/AJP.0b013e31822ed2f3.
PMID: 22001667
citation: Eisenstat SA, Ulman K, Siegel AL, Carlson K. Diabetes group visits: integrated medical care and behavioral support to improve diabetes care and outcomes from a primary care perspective. Curr Diab Rep. 2013 Apr;13(2):177-87. doi: 10.1007/s11892-012-0349-5.
PMID: 23207990
citation: Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.
PMID: 25105072
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Our limitations for this study includes: study participation (intervention group did not all attend IMGV and not everyone in control group attended PCP visit), no data on baseline antidepressants medication, only English speaking patients included.
point of contact: 