<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/NCT03265600</url>
  </required_header>
  <id_info>
    <org_study_id>CHA-IRB-1002/08/14_2</org_study_id>
    <secondary_id>UH2AT009145</secondary_id>
    <nct_id>NCT03265600</nct_id>
  </id_info>
  <brief_title>Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)</brief_title>
  <acronym>MINDFUL-PC-2</acronym>
  <official_title>MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Comparative Effectiveness Trial of Chronic Illness Self-Management and Action Plan Initiation Among Primary Care Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge Health Alliance</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Arthur Vining Davis Foundations</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Arnold P. Gold Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge Health Alliance</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Among primary care patients, compare the effectiveness of an 8-week mindfulness-based&#xD;
      intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness&#xD;
      introduction comparator on self-management of chronic illness and illness-related health&#xD;
      behavior action plan initiation, as well as on measures related to anxiety, depression, and&#xD;
      stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study builds on a pilot study that investigated the impact of Mindfulness Training for&#xD;
      Primary Care on anxiety, depression, stress, and chronic illness self-management in primary&#xD;
      care patients receiving care in an urban, community, multi-cultural safety net healthcare&#xD;
      system. The current comparative effectiveness randomized controlled trial takes place in a&#xD;
      larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects&#xD;
      of self-regulation such as action plan initiation, while examining potential mechanisms of&#xD;
      change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion&#xD;
      regulation, and body awareness. Participants randomized to MTPC are compared with&#xD;
      participants who are randomized to a low-dose comparator condition and receive a 1-hour&#xD;
      introduction to mindfulness with a referral to community mindfulness resources. Outcome&#xD;
      assessments are conducted at baseline and study weeks 8-10.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Action Plan Initiation Survey (APIS-5)</measure>
    <time_frame>Weeks 8-10</time_frame>
    <description>The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable).&#xD;
For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Five Facet Mindfulness Questionnaire (FFMQ)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: &quot;observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.&quot; Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Compassion Scale-Short Form (SCS-SF)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy for Managing Chronic Disease (SECD-6)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Control Questionnaire (PCQ)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty in Emotion Regulation Scale (DERS)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Assessment of Interoceptive Awareness (MAIA)</measure>
    <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
    <description>The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Stress Related Disorder</condition>
  <condition>Adjustment Disorders</condition>
  <arm_group>
    <arm_group_label>Mindfulness Training for Primary Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-dose Comparator</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Training for Primary Care</intervention_name>
    <description>MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
    <arm_group_label>Mindfulness Training for Primary Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>60-minute Introduction to Mindfulness</intervention_name>
    <description>Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
    <arm_group_label>Low-dose Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current CHA patient with an enrolled CHA primary care doctor.&#xD;
&#xD;
          -  CHA patients 18 years of age and older.&#xD;
&#xD;
          -  Able to tolerate and participate in interviews and engage in all procedures.&#xD;
&#xD;
          -  Able to give written consent in English OR willing and able to provide consent and&#xD;
             complete assessments through a professional language translator when necessary.&#xD;
&#xD;
          -  Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety&#xD;
             disorder, depression, or adjustment disorder related to chronic illness, pain, etc.).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any cognitive impairment that precludes informed consent.&#xD;
&#xD;
          -  Patients who, in the opinion of the Principal Investigator, pose an imminent risk of&#xD;
             suicide or danger to self or others.&#xD;
&#xD;
          -  Likelihood of potential incarceration such as a conviction or pending charges that may&#xD;
             potentially result in imprisonment.&#xD;
&#xD;
          -  Previous enrollment or randomization of treatment in the present study within the 12&#xD;
             months.&#xD;
&#xD;
          -  Behaviors that may cause disruption to a mindfulness group.&#xD;
&#xD;
          -  Patients with symptoms of psychosis, thought disorder, and/or severe mental illness,&#xD;
             including schizophrenia, schizoaffective, bipolar disorder, or a current severe&#xD;
             episode of major depressive disorder.&#xD;
&#xD;
          -  Lack of insurance coverage for group psychotherapy may preclude participation in&#xD;
             groups.&#xD;
&#xD;
          -  Patients in their third trimester of pregnancy who foresee conflicts that preclude&#xD;
             their commitment to completing all activities.&#xD;
&#xD;
          -  Patients with highly unstable medical problems that put them at a high risk of&#xD;
             hospitalization.&#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>Zev D Schuman-Olivier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cambridge Health Alliance</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cambridge Health Alliance</name>
      <address>
        <city>Somerville</city>
        <state>Massachusetts</state>
        <zip>02143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, Lopez-del-Hoyo Y, Garcia-Campayo J. The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review. Ann Fam Med. 2015 Nov;13(6):573-82. doi: 10.1370/afm.1863.</citation>
    <PMID>26553897</PMID>
  </reference>
  <reference>
    <citation>Mccubbin T, Dimidjian S, Kempe K, Glassey MS, Ross C, Beck A. Mindfulness-based stress reduction in an integrated care delivery system: one-year impacts on patient-centered outcomes and health care utilization. Perm J. 2014 Fall;18(4):4-9. doi: 10.7812/TPP/14-014.</citation>
    <PMID>25662520</PMID>
  </reference>
  <reference>
    <citation>Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.</citation>
    <PMID>25431430</PMID>
  </reference>
  <reference>
    <citation>Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health. 2010;16(3):200-10. doi: 10.1071/PY09063.</citation>
    <PMID>20815988</PMID>
  </reference>
  <reference>
    <citation>Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.</citation>
    <PMID>24395196</PMID>
  </reference>
  <reference>
    <citation>Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.</citation>
    <PMID>20350028</PMID>
  </reference>
  <reference>
    <citation>Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.</citation>
    <PMID>26168376</PMID>
  </reference>
  <reference>
    <citation>Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.</citation>
    <PMID>11769298</PMID>
  </reference>
  <reference>
    <citation>Schuman-Olivier Z, Hoeppner BB, Evins AE, Brewer JA. Finding the right match: mindfulness training may potentiate the therapeutic effect of nonjudgment of inner experience on smoking cessation. Subst Use Misuse. 2014 Apr;49(5):586-94. doi: 10.3109/10826084.2014.850254.</citation>
    <PMID>24611853</PMID>
  </reference>
  <reference>
    <citation>Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.</citation>
    <PMID>19842003</PMID>
  </reference>
  <reference>
    <citation>Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.</citation>
    <PMID>23070875</PMID>
  </reference>
  <reference>
    <citation>Wiegner L, Hange D, Bjorkelund C, Ahlborg G Jr. Prevalence of perceived stress and associations to symptoms of exhaustion, depression and anxiety in a working age population seeking primary care--an observational study. BMC Fam Pract. 2015 Mar 19;16:38. doi: 10.1186/s12875-015-0252-7.</citation>
    <PMID>25880219</PMID>
  </reference>
  <reference>
    <citation>Benzo RP. Mindfulness and motivational interviewing: two candidate methods for promoting self-management. Chron Respir Dis. 2013 Aug;10(3):175-82. doi: 10.1177/1479972313497372.</citation>
    <PMID>23897933</PMID>
  </reference>
  <reference>
    <citation>Gawande R, To MN, Pine E, Griswold T, Creedon TB, Brunel A, Lozada A, Loucks EB, Schuman-Olivier Z. Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial. J Gen Intern Med. 2019 Feb;34(2):293-302. doi: 10.1007/s11606-018-4739-5. Epub 2018 Dec 3.</citation>
    <PMID>30511291</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>September 19, 2019</results_first_submitted>
  <results_first_submitted_qc>November 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 3, 2019</results_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adjustment Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03265600/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 11 metro-north Boston primary care Patient Centered Medical Homes via print and digital flyers, as well as referrals from primary and mental health care settings confirmed by a primary care provider. 465 participants were recruited.</recruitment_details>
      <pre_assignment_details>All participants received a 60-minute introduction to mindfulness led by an MTPC group leader prior to randomization. The session included a conceptual/experiential mindfulness introduction, inquiry, and digital and print resources. Participants were able to decline study continuation after the 60-minute introduction and before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness Training for Primary Care</title>
          <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
        </group>
        <group group_id="P2">
          <title>Low-dose Comparator</title>
          <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68">Completed 8 or 9 week Action Plan Initiation Survey</participants>
                <participants group_id="P2" count="32">Completed 8 or 9 week Action Plan Initiation Survey</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="12"/>
              </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="17"/>
                <participants group_id="P2" count="5"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Partially completed 8 wk or 24 wk survey</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mindfulness Training for Primary Care</title>
          <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
        </group>
        <group group_id="B2">
          <title>Low-dose Comparator</title>
          <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</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="92"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="136"/>
          </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="40.6" spread="12.7"/>
                    <measurement group_id="B2" value="40.3" spread="12.2"/>
                    <measurement group_id="B3" value="40.5" spread="12.5"/>
                  </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="63"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>English as second language</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Annual Income &lt;$20,000</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Single</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Married/cohabitating</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Widowed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.6" spread="3.1"/>
                    <measurement group_id="B2" value="15.5" spread="4.1"/>
                    <measurement group_id="B3" value="16.2" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Medicaid or Medicare</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subsidized</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Private</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Have practiced meditation before</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline meditation practice</title>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.8" spread="10.5"/>
                    <measurement group_id="B2" value="4.1" spread="6.5"/>
                    <measurement group_id="B3" value="5.9" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DSM-V diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Single DSM-V diagnosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2+ DSM-V diagnosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary DSM-V diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Major depressive disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Generalized anxiety disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Anxiety NOS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adjustment disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other depressive disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any PTSD diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any depression diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Action Plan Initiation Survey (APIS-5)</title>
        <description>The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable).&#xD;
For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.</description>
        <time_frame>Weeks 8-10</time_frame>
        <population>Using mixed effects intent-to-treat analysis, we defined non-initiator status as participants who never endorsed greater than 4 or who did not complete the API survey. by week 9. The APIS-5 is analyzed using an intent to treat analysis and missing APIS is considered incomplete action plan initiation.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Action Plan Initiation Survey (APIS-5)</title>
          <description>The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable).&#xD;
For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.</description>
          <population>Using mixed effects intent-to-treat analysis, we defined non-initiator status as participants who never endorsed greater than 4 or who did not complete the API survey. by week 9. The APIS-5 is analyzed using an intent to treat analysis and missing APIS is considered incomplete action plan initiation.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="14"/>
                  </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>0.006</p_value>
            <method>Unadjusted bivariate logistic regression</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.91</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Perceived Stress Scale</title>
        <description>The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Stress Scale</title>
          <description>The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" spread="6.7"/>
                    <measurement group_id="O2" value="24.3" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" spread="6.3"/>
                    <measurement group_id="O2" value="20.9" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: -0.25</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)</title>
        <description>The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)</title>
          <description>The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.9" spread="6.9"/>
                    <measurement group_id="O2" value="61.9" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5" spread="6.6"/>
                    <measurement group_id="O2" value="58.9" spread="6.9"/>
                  </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>
            <p_value>0.12</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: -0.36</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)</title>
        <description>The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)</title>
          <description>The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2" spread="8.6"/>
                    <measurement group_id="O2" value="58.0" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.9" spread="7.9"/>
                    <measurement group_id="O2" value="55.6" spread="8.0"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: -0.34</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Five Facet Mindfulness Questionnaire (FFMQ)</title>
        <description>The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: &quot;observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.&quot; Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Five Facet Mindfulness Questionnaire (FFMQ)</title>
          <description>The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: &quot;observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.&quot; Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.8" spread="18.2"/>
                    <measurement group_id="O2" value="115.6" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132.0" spread="16.9"/>
                    <measurement group_id="O2" value="119.4" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: 0.57</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Compassion Scale-Short Form (SCS-SF)</title>
        <description>The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion.</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Compassion Scale-Short Form (SCS-SF)</title>
          <description>The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion.</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.67"/>
                    <measurement group_id="O2" value="2.6" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.65"/>
                    <measurement group_id="O2" value="2.8" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: 0.41</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-Efficacy for Managing Chronic Disease (SECD-6)</title>
        <description>The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-Efficacy for Managing Chronic Disease (SECD-6)</title>
          <description>The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="1.9"/>
                    <measurement group_id="O2" value="6.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="1.6"/>
                    <measurement group_id="O2" value="6.5" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.31</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: 0.15</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Control Questionnaire (PCQ)</title>
        <description>The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Control Questionnaire (PCQ)</title>
          <description>The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5" spread="4.4"/>
                    <measurement group_id="O2" value="23.0" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" spread="4.2"/>
                    <measurement group_id="O2" value="23.8" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: 0.22</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difficulty in Emotion Regulation Scale (DERS)</title>
        <description>The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Difficulty in Emotion Regulation Scale (DERS)</title>
          <description>The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.1" spread="23.0"/>
                    <measurement group_id="O2" value="72.2" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.2" spread="21.8"/>
                    <measurement group_id="O2" value="68.8" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: -0.58</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multidimensional Assessment of Interoceptive Awareness (MAIA)</title>
        <description>The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).</description>
        <time_frame>Baseline and week 8 (pre to post Intervention)</time_frame>
        <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Primary Care</title>
            <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
          </group>
          <group group_id="O2">
            <title>Low-dose Comparator</title>
            <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</description>
          </group>
        </group_list>
        <measure>
          <title>Multidimensional Assessment of Interoceptive Awareness (MAIA)</title>
          <description>The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).</description>
          <population>We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.73"/>
                    <measurement group_id="O2" value="2.5" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.64"/>
                    <measurement group_id="O2" value="2.6" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Cohen's d: 0.75</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions.</time_frame>
      <desc>An adverse event is any untoward medical occurrence in a subject during participation in the clinical study. An adverse finding can include a sign, symptom, abnormal assessment (from vital signs or brain imaging), or any combination of these. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: &quot;mild&quot; if it does not have major impact, &quot;moderate&quot; if it causes some minor inconvenience, and &quot;severe&quot; if it causes substantial disruption.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness Training for Primary Care</title>
          <description>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.&#xD;
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.</description>
        </group>
        <group group_id="E2">
          <title>Low-dose Comparator</title>
          <description>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.&#xD;
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.</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="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diagnosed with colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric hospitalization, hypomanic episode</sub_title>
                <description>Worsening of underlying condition</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Psychiatric hospitalization, increased PTSD symptoms</sub_title>
                <description>Worsening of underlying condition</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Psychiatric hospitalization, suicidal ideation</sub_title>
                <description>Worsening of underlying condition</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="8" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>ED visit due to hearing loss, ear pain, tinnitus</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Back injury</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Motor vehicle accident</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Motor vehicle accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ED visit for alcohol abuse</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Binge drinking</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Flashback during MTPC All-Day Session</sub_title>
                <description>Participant calmed himself, finished the session, and received consultation from group leaders</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Increased Anxiety during Open Awareness Practice</sub_title>
                <description>Participant consulted with the group leader and continued participating</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Admission for flu and UTI</sub_title>
                <description>This event was reported to CHA IRB, which responded on 5/17/2018 that this event is not considered an SAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>ED visit after alleged sexual assault</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Zev Schuman-Olivier</name_or_title>
      <organization>Cambridge Health Alliance</organization>
      <phone>617-591-6132</phone>
      <email>zschuman@cha.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265600
org study id: CHA-IRB-1002/08/14_2
secondary id: UH2AT009145
nct id: NCT03265600
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Among primary care patients, compare the effectiveness of an 8-week mindfulness-based
      intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness
      introduction comparator on self-management of chronic illness and illness-related health
      behavior action plan initiation, as well as on measures related to anxiety, depression, and
      stress.
This study builds on a pilot study that investigated the impact of Mindfulness Training for
      Primary Care on anxiety, depression, stress, and chronic illness self-management in primary
      care patients receiving care in an urban, community, multi-cultural safety net healthcare
      system. The current comparative effectiveness randomized controlled trial takes place in a
      larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects
      of self-regulation such as action plan initiation, while examining potential mechanisms of
      change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion
      regulation, and body awareness. Participants randomized to MTPC are compared with
      participants who are randomized to a low-dose comparator condition and receive a 1-hour
      introduction to mindfulness with a referral to community mindfulness resources. Outcome
      assessments are conducted at baseline and study weeks 8-10.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.
primary purpose: Treatment
masking: None (Open Label)
measure: Action Plan Initiation Survey (APIS-5)
time frame: Weeks 8-10
description: The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable).
For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.
measure: Perceived Stress Scale
time frame: Baseline and week 8 (pre to post Intervention)
description: The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).
measure: Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
time frame: Baseline and week 8 (pre to post Intervention)
description: The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).
measure: Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
time frame: Baseline and week 8 (pre to post Intervention)
description: The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).
measure: Five Facet Mindfulness Questionnaire (FFMQ)
time frame: Baseline and week 8 (pre to post Intervention)
description: The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: "observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience." Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome).
measure: Self-Compassion Scale-Short Form (SCS-SF)
time frame: Baseline and week 8 (pre to post Intervention)
description: The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion.
measure: Change in Self-Efficacy for Managing Chronic Disease (SECD-6)
time frame: Baseline and week 8 (pre to post Intervention)
description: The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy).
measure: Perceived Control Questionnaire (PCQ)
time frame: Baseline and week 8 (pre to post Intervention)
description: The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control).
measure: Difficulty in Emotion Regulation Scale (DERS)
time frame: Baseline and week 8 (pre to post Intervention)
description: The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
time frame: Baseline and week 8 (pre to post Intervention)
description: The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).
arm group label: Mindfulness Training for Primary Care
arm group type: Active Comparator
description: Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.
arm group label: Low-dose Comparator
arm group type: Other
description: Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.
intervention type: Behavioral
intervention name: Mindfulness Training for Primary Care
description: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.
arm group label: Mindfulness Training for Primary Care
intervention type: Behavioral
intervention name: 60-minute Introduction to Mindfulness
description: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
arm group label: Low-dose Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zev D Schuman-Olivier, MD
role: Principal Investigator
affiliation: Cambridge Health Alliance
facility: 
country: United States
citation: Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, Lopez-del-Hoyo Y, Garcia-Campayo J. The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review. Ann Fam Med. 2015 Nov;13(6):573-82. doi: 10.1370/afm.1863.
PMID: 26553897
citation: Mccubbin T, Dimidjian S, Kempe K, Glassey MS, Ross C, Beck A. Mindfulness-based stress reduction in an integrated care delivery system: one-year impacts on patient-centered outcomes and health care utilization. Perm J. 2014 Fall;18(4):4-9. doi: 10.7812/TPP/14-014.
PMID: 25662520
citation: Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.
PMID: 25431430
citation: Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health. 2010;16(3):200-10. doi: 10.1071/PY09063.
PMID: 20815988
citation: Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
PMID: 24395196
citation: Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
PMID: 20350028
citation: Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.
PMID: 26168376
citation: Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
PMID: 11769298
citation: Schuman-Olivier Z, Hoeppner BB, Evins AE, Brewer JA. Finding the right match: mindfulness training may potentiate the therapeutic effect of nonjudgment of inner experience on smoking cessation. Subst Use Misuse. 2014 Apr;49(5):586-94. doi: 10.3109/10826084.2014.850254.
PMID: 24611853
citation: Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.
PMID: 19842003
citation: Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.
PMID: 23070875
citation: Wiegner L, Hange D, Bjorkelund C, Ahlborg G Jr. Prevalence of perceived stress and associations to symptoms of exhaustion, depression and anxiety in a working age population seeking primary care--an observational study. BMC Fam Pract. 2015 Mar 19;16:38. doi: 10.1186/s12875-015-0252-7.
PMID: 25880219
citation: Benzo RP. Mindfulness and motivational interviewing: two candidate methods for promoting self-management. Chron Respir Dis. 2013 Aug;10(3):175-82. doi: 10.1177/1479972313497372.
PMID: 23897933
citation: Gawande R, To MN, Pine E, Griswold T, Creedon TB, Brunel A, Lozada A, Loucks EB, Schuman-Olivier Z. Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial. J Gen Intern Med. 2019 Feb;34(2):293-302. doi: 10.1007/s11606-018-4739-5. Epub 2018 Dec 3.
PMID: 30511291
responsible party type: Sponsor
mesh term: Adjustment Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 