<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/NCT03781336</url>
  </required_header>
  <id_info>
    <org_study_id>17-MH-0018</org_study_id>
    <nct_id>NCT03781336</nct_id>
  </id_info>
  <brief_title>Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals</brief_title>
  <official_title>Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Stress among healthcare professionals is well documented. Untreated stress can lead to&#xD;
      anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to&#xD;
      reduce stress and enhance wellbeing, among health care professionals, has increased with&#xD;
      promising results. Typical mindfulness-based programs are 30 hours in length across 9&#xD;
      sessions. The purpose of this study is to assess the effectiveness of a shorter and more&#xD;
      practical program that could be offered during work hours to health care professionals at the&#xD;
      NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This abridged program was designed by Dr. Rezvan Ameli who is an expert in mindfulness-based&#xD;
      practices/therapies and was in response to the expressed needs of the NIH clinical staff and&#xD;
      the NIH fellowship training program.&#xD;
&#xD;
      Participants completed all primary and secondary outcome measure questionnaires at week -1, 5&#xD;
      and 13. The life as usual control group completed all primary and secondary outcome measures&#xD;
      at week -1, and 5.&#xD;
&#xD;
      The program is described below:&#xD;
&#xD;
      The program consisted of 5 sessions. A class binder was prepared for the participants and&#xD;
      included information about mindfulness and its practice, practices covered in each session,&#xD;
      Practice Plan work sheets to design home practices, pertinent reference list, guide to online&#xD;
      services, programs and apps, selected poetry, and information regarding recorded instructions&#xD;
      for body scan and mindful breathing by the instructor which was made available on the&#xD;
      institution's website and could be downloaded by the participants. Each session was 1.5 hours&#xD;
      in length and was offered on Fridays from 3-4:30 pm. Classes were instructed by Rezvan Ameli,&#xD;
      Ph.D., clinical psychologist, an experienced mindfulness practitioner since 2003 and teacher&#xD;
      since 2008. In addition to her background as a licensed clinical psychologist, mindfulness&#xD;
      practitioner, teacher and writer (Ameli 2013), RA is a certified yoga teacher and is&#xD;
      registered with the Yoga Alliance (RYT-200).&#xD;
&#xD;
      Common Elements of the Sessions&#xD;
&#xD;
      The first 4 classes began with 20-25 minutes of mindful movement/ light yoga (TNH sounds&#xD;
      true, ITP kata). We did not include movements in the 5th (last) session due to time&#xD;
      constraints. The emphasis during mindful movements was on the coordination of movement and&#xD;
      the breath with the instruction that when the mind wandered away to gently bring it back and&#xD;
      refocus on the breath and movements. Participants were encouraged to only engage in movements&#xD;
      that felt comfortable but not straining, painful, or felt unsafe. Each class had a period of&#xD;
      &quot;check in&quot;. During the first check in, participants shared their names, a brief statement&#xD;
      about the reason for their participation, and their current self-care practice/s if any.&#xD;
      Class guidelines including confidentiality were reviewed at this time. In subsequent&#xD;
      check-ins the participants addressed their questions regarding mindfulness practices and&#xD;
      class teachings, described their practice with a focus on self-care, their existing self-care&#xD;
      practices and new learnings from the class, and any obstacles to their practice and to their&#xD;
      self-care during the preceding week. Other common elements of the sessions included a period&#xD;
      of inquiry, i.e. question and answer, after each new practice was introduced, planning a week&#xD;
      of practice based on class learnings, post class ratings, and concluding the class with a&#xD;
      relevant poem. Home practice planning was done in dyads of participants who were then&#xD;
      encouraged to stay in touch, become a &quot;buddy&quot; to their class partner, and communicate during&#xD;
      the week about their practice. Every session included a period of mindful breathing. The&#xD;
      length of mindful breathing (sitting meditation) was gradually increased from 10 minutes in&#xD;
      the 1st session to 30 minutes in the 5th session.&#xD;
&#xD;
      Session Specific Practices&#xD;
&#xD;
      In addition to these common elements, each session included a theme and other specific&#xD;
      mindfulness practices as follows:&#xD;
&#xD;
        -  Session 1- Theme: Introduction to mindfulness. This session included definition of&#xD;
           mindfulness and its foundations (Kabat-Zin, 1992), mindful breathing and body scan.&#xD;
&#xD;
        -  Session 2- Theme: Enhancing Awareness &amp; Focused Attention. This session included&#xD;
           mindfulness of sounds, a short body scan, mindful breathing, and mindful eating, i.e.&#xD;
           the &quot;raisin exercise&quot; (ref). In addition, a discussion of mindful consumption and its&#xD;
           relevance to self-care was explored (Ameli 2013).&#xD;
&#xD;
        -  Session 3 -Theme: Awareness of pleasurable experiences. This session included&#xD;
           mindfulness of the breath (briefly incorporating sounds, body sensation, thoughts,&#xD;
           feelings and then focusing on the breath), and mindful walking. The importance of&#xD;
           awareness of pleasurable experiences were discussed and an exercise to enhance attention&#xD;
           to pleasurable experiences was performed in dyads (Ameli 2013).&#xD;
&#xD;
        -  Session 4- Theme: Transformation of difficult emotions through mindfulness. In this&#xD;
           session the concept of transforming difficult emotions through the practice of&#xD;
           mindfulness was discussed, explored, and practiced. The acronym RAIN (recognize,&#xD;
           accept/allow, investigate, and non-identification) was utilized to facilitate this&#xD;
           practice.&#xD;
&#xD;
        -  Session 5- Theme: Compassion. This session mindful breathing and a general discussion of&#xD;
           compassion, compassion towards self and other, and the practice of loving kindness&#xD;
           (Ameli 2013). The class was concluded with a &quot;check-out&quot; where participants briefly&#xD;
           shared their overall experiences and learnings and their goals/vision for future&#xD;
           self-care activities and practices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 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>Participants are allocated into the mindfulness-based self-care group or a wait list group for 5 weeks. Since the group is offered during work hours, the waitlist group could be best described as &quot;life as usual&quot;. After group allocation, all participants completed demographic and self report clinical assessments at baseline, and self report clinical assessments at follow-up.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mindful Attention Awareness Scale (MAAS) - Trait Version</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>The Mindful Attention Awareness Scale-Trait Version (MAAS-T) is used to assess self-reported trait mindfulness. It is a 15-item scale, with a total range from 0 (low mindfulness) to 90 (high mindfulness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Attention Awareness Scale (MAAS) - State Version</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>The Mindful Attention Awareness Scale-State Version (MAAS-S) is used to assess self-reported state mindfulness. It is a 5-item scale, with a total range from 0 (high mindfulness) to 30 (low mindfulness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Affect Scores (PANAS)</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).&#xD;
These are the Positive Affect Scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale-Anxiety (VAS-A)</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>Visual Analog Scale-Anxiety (VAS-A) is used to assess self-reported anxiety. It is a 1-item scale, with a total range from 1 (low anxiety) to 10 (high anxiety).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Self Care Scale-General (MSCS-G)</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>Mindful Self Care Scale-General (MSCS-G) is used to assess self-reported mindful self care. It is a 3-item scale, with a total range from 0 (low self care) to 12 (high self care).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maslach Burnout Inventory (MBI)</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>The Maslach Burnout Inventory (MBI 2-Item) is used to assess self-reported burnout. The 2-Item inventory assesses emotional exhaustion (Item-1) and depersonalization (Item-2) separately from 1 (no symptoms) to 7 (highest severity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Affect Scores (PANAS)</measure>
    <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
    <description>The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).&#xD;
These are the Negative Affect Scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Stress, Professional</condition>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based self-care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness-based self-care (5 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Life as usual control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Life as usual control (5 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based self care</intervention_name>
    <description>Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
    <arm_group_label>Mindfulness-based self-care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any National Institutes of Health (NIH) employee, contractor, or trainee willing and&#xD;
             able to participate in a 5-week mindfulness-based self-care course during the work&#xD;
             day.&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Persons with medical and psychiatric conditions were advised to consult with their&#xD;
             health care practitioners prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rezvan Ameli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ameli, R. (2013). 25 Lessons in Mindfulness : Now Time for Healthy Living (First edition. ed.). Washington, D.C.: American Psychological Association.</citation>
  </reference>
  <reference>
    <citation>Krasner MS, Epstein RM, Beckman H, Suchman AL, Chapman B, Mooney CJ, Quill TE. Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians. JAMA. 2009 Sep 23;302(12):1284-93. doi: 10.1001/jama.2009.1384.</citation>
    <PMID>19773563</PMID>
  </reference>
  <reference>
    <citation>de Vibe M, Solhaug I, Rosenvinge JH, Tyssen R, Hanley A, Garland E. Six-year positive effects of a mindfulness-based intervention on mindfulness, coping and well-being in medical and psychology students; Results from a randomized controlled trial. PLoS One. 2018 Apr 24;13(4):e0196053. doi: 10.1371/journal.pone.0196053. eCollection 2018.</citation>
    <PMID>29689081</PMID>
  </reference>
  <reference>
    <citation>West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.</citation>
    <PMID>27692469</PMID>
  </reference>
  <reference>
    <citation>Dyrbye LN, Shanafelt TD. Physician burnout: a potential threat to successful health care reform. JAMA. 2011 May 18;305(19):2009-10. doi: 10.1001/jama.2011.652. No abstract available.</citation>
    <PMID>21586718</PMID>
  </reference>
  <reference>
    <citation>West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.</citation>
    <PMID>24515493</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>February 19, 2021</results_first_submitted>
  <results_first_submitted_qc>March 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 15, 2021</results_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institutes of Health Clinical Center (CC)</investigator_affiliation>
    <investigator_full_name>Rezvan Ameli</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>mindfulness</keyword>
  <keyword>stress</keyword>
  <keyword>resilience building</keyword>
  <keyword>meditation</keyword>
  <keyword>healthcare professionals</keyword>
  <keyword>trainees</keyword>
  <keyword>physicians</keyword>
  <keyword>nurses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Occupational Stress</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03781336/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness-based Self-care</title>
          <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
        </group>
        <group group_id="P2">
          <title>Life as Usual Control</title>
          <description>Life as usual control (5 weeks)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43">All participants were included in the analysis (Intent to treat)</participants>
                <participants group_id="P2" count="35">All participants were included in the analysis (Intent to treat)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mindfulness-based Self-care</title>
          <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
        </group>
        <group group_id="B2">
          <title>Life as Usual Control</title>
          <description>Life as usual control (5 weeks)</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="43"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="78"/>
          </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="35.7" spread="15.4"/>
                    <measurement group_id="B2" value="36.4" spread="13.0"/>
                    <measurement group_id="B3" value="36.0" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </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="28"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced or separated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Widowed or other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Religion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Agnostic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Atheism</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Buddhism</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Christianity</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hinduism</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Islam</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Judaism</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not affiliated or other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current position</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Administrator</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nurse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PhD Scientist</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Physician</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Social Worker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Training Fellow</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Some college</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>Completed college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate school or Advance degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preexisting condition</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Medical condition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatric condition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Perceived Stress Scale (PSS)</title>
        <description>The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Stress Scale (PSS)</title>
          <description>The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).</description>
          <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="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.63" spread="6.26"/>
                    <measurement group_id="O2" value="18.80" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.29" spread="5.84"/>
                    <measurement group_id="O2" value="18.54" spread="6.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.80" spread="6.45"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mindful Attention Awareness Scale (MAAS) - Trait Version</title>
        <description>The Mindful Attention Awareness Scale-Trait Version (MAAS-T) is used to assess self-reported trait mindfulness. It is a 15-item scale, with a total range from 0 (low mindfulness) to 90 (high mindfulness).</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Mindful Attention Awareness Scale (MAAS) - Trait Version</title>
          <description>The Mindful Attention Awareness Scale-Trait Version (MAAS-T) is used to assess self-reported trait mindfulness. It is a 15-item scale, with a total range from 0 (low mindfulness) to 90 (high mindfulness).</description>
          <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="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.74" spread="0.99"/>
                    <measurement group_id="O2" value="3.61" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="0.83"/>
                    <measurement group_id="O2" value="3.70" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="0.85"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mindful Attention Awareness Scale (MAAS) - State Version</title>
        <description>The Mindful Attention Awareness Scale-State Version (MAAS-S) is used to assess self-reported state mindfulness. It is a 5-item scale, with a total range from 0 (high mindfulness) to 30 (low mindfulness).</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Mindful Attention Awareness Scale (MAAS) - State Version</title>
          <description>The Mindful Attention Awareness Scale-State Version (MAAS-S) is used to assess self-reported state mindfulness. It is a 5-item scale, with a total range from 0 (high mindfulness) to 30 (low mindfulness).</description>
          <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="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="1.24"/>
                    <measurement group_id="O2" value="2.48" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.74" spread="1.18"/>
                    <measurement group_id="O2" value="2.78" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.08" spread="1.04"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Affect Scores (PANAS)</title>
        <description>The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).&#xD;
These are the Positive Affect Scores</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Affect Scores (PANAS)</title>
          <description>The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).&#xD;
These are the Positive Affect Scores</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.85" spread="7.73"/>
                    <measurement group_id="O2" value="33.67" spread="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.69" spread="7.12"/>
                    <measurement group_id="O2" value="31.42" spread="7.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.13" spread="8.43"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale-Anxiety (VAS-A)</title>
        <description>Visual Analog Scale-Anxiety (VAS-A) is used to assess self-reported anxiety. It is a 1-item scale, with a total range from 1 (low anxiety) to 10 (high anxiety).</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale-Anxiety (VAS-A)</title>
          <description>Visual Analog Scale-Anxiety (VAS-A) is used to assess self-reported anxiety. It is a 1-item scale, with a total range from 1 (low anxiety) to 10 (high anxiety).</description>
          <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="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.72" spread="1.62"/>
                    <measurement group_id="O2" value="4.57" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.58" spread="1.52"/>
                    <measurement group_id="O2" value="4.23" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="1.47"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mindful Self Care Scale-General (MSCS-G)</title>
        <description>Mindful Self Care Scale-General (MSCS-G) is used to assess self-reported mindful self care. It is a 3-item scale, with a total range from 0 (low self care) to 12 (high self care).</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Mindful Self Care Scale-General (MSCS-G)</title>
          <description>Mindful Self Care Scale-General (MSCS-G) is used to assess self-reported mindful self care. It is a 3-item scale, with a total range from 0 (low self care) to 12 (high self care).</description>
          <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="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.60" spread="2.75"/>
                    <measurement group_id="O2" value="6.00" spread="2.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.29" spread="2.44"/>
                    <measurement group_id="O2" value="5.54" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.37" spread="2.76"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maslach Burnout Inventory (MBI)</title>
        <description>The Maslach Burnout Inventory (MBI 2-Item) is used to assess self-reported burnout. The 2-Item inventory assesses emotional exhaustion (Item-1) and depersonalization (Item-2) separately from 1 (no symptoms) to 7 (highest severity).</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Maslach Burnout Inventory (MBI)</title>
          <description>The Maslach Burnout Inventory (MBI 2-Item) is used to assess self-reported burnout. The 2-Item inventory assesses emotional exhaustion (Item-1) and depersonalization (Item-2) separately from 1 (no symptoms) to 7 (highest severity).</description>
          <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="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline-item 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.95" spread="1.56"/>
                    <measurement group_id="O2" value="3.29" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention-item 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.89" spread="1.63"/>
                    <measurement group_id="O2" value="2.74" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up-item 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.31" spread="1.64"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline-item 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="1.32"/>
                    <measurement group_id="O2" value="1.6" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention-item 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="1.13"/>
                    <measurement group_id="O2" value="1.57" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up-item 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="1.21"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Affect Scores (PANAS)</title>
        <description>The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).&#xD;
These are the Negative Affect Scores</description>
        <time_frame>Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Self-care</title>
            <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
          </group>
          <group group_id="O2">
            <title>Life as Usual Control</title>
            <description>Life as usual control (5 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Affect Scores (PANAS)</title>
          <description>The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).&#xD;
These are the Negative Affect Scores</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.44" spread="7.38"/>
                    <measurement group_id="O2" value="21.21" spread="7.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postintervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.73" spread="6.24"/>
                    <measurement group_id="O2" value="19.09" spread="7.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.22" spread="6.01"/>
                    <measurement group_id="O2" value="NA" spread="NA">Follow-up data not collected from the life as usual control subjects.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Week-5 (post-intervention)</time_frame>
      <desc>Adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness-based Self-care</title>
          <description>Mindfulness-based self-care (5 weeks)&#xD;
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.</description>
        </group>
        <group group_id="E2">
          <title>Life as Usual Control</title>
          <description>Life as usual control (5 weeks)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </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>Psychologist</name_or_title>
      <organization>National Institutes of Health</organization>
      <phone>3014027360</phone>
      <email>amelir@mail.nih.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03781336
org study id: 17-MH-0018
nct id: NCT03781336
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stress among healthcare professionals is well documented. Untreated stress can lead to
      anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to
      reduce stress and enhance wellbeing, among health care professionals, has increased with
      promising results. Typical mindfulness-based programs are 30 hours in length across 9
      sessions. The purpose of this study is to assess the effectiveness of a shorter and more
      practical program that could be offered during work hours to health care professionals at the
      NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.
This abridged program was designed by Dr. Rezvan Ameli who is an expert in mindfulness-based
      practices/therapies and was in response to the expressed needs of the NIH clinical staff and
      the NIH fellowship training program.

      Participants completed all primary and secondary outcome measure questionnaires at week -1, 5
      and 13. The life as usual control group completed all primary and secondary outcome measures
      at week -1, and 5.

      The program is described below:

      The program consisted of 5 sessions. A class binder was prepared for the participants and
      included information about mindfulness and its practice, practices covered in each session,
      Practice Plan work sheets to design home practices, pertinent reference list, guide to online
      services, programs and apps, selected poetry, and information regarding recorded instructions
      for body scan and mindful breathing by the instructor which was made available on the
      institution's website and could be downloaded by the participants. Each session was 1.5 hours
      in length and was offered on Fridays from 3-4:30 pm. Classes were instructed by Rezvan Ameli,
      Ph.D., clinical psychologist, an experienced mindfulness practitioner since 2003 and teacher
      since 2008. In addition to her background as a licensed clinical psychologist, mindfulness
      practitioner, teacher and writer (Ameli 2013), RA is a certified yoga teacher and is
      registered with the Yoga Alliance (RYT-200).

      Common Elements of the Sessions

      The first 4 classes began with 20-25 minutes of mindful movement/ light yoga (TNH sounds
      true, ITP kata). We did not include movements in the 5th (last) session due to time
      constraints. The emphasis during mindful movements was on the coordination of movement and
      the breath with the instruction that when the mind wandered away to gently bring it back and
      refocus on the breath and movements. Participants were encouraged to only engage in movements
      that felt comfortable but not straining, painful, or felt unsafe. Each class had a period of
      "check in". During the first check in, participants shared their names, a brief statement
      about the reason for their participation, and their current self-care practice/s if any.
      Class guidelines including confidentiality were reviewed at this time. In subsequent
      check-ins the participants addressed their questions regarding mindfulness practices and
      class teachings, described their practice with a focus on self-care, their existing self-care
      practices and new learnings from the class, and any obstacles to their practice and to their
      self-care during the preceding week. Other common elements of the sessions included a period
      of inquiry, i.e. question and answer, after each new practice was introduced, planning a week
      of practice based on class learnings, post class ratings, and concluding the class with a
      relevant poem. Home practice planning was done in dyads of participants who were then
      encouraged to stay in touch, become a "buddy" to their class partner, and communicate during
      the week about their practice. Every session included a period of mindful breathing. The
      length of mindful breathing (sitting meditation) was gradually increased from 10 minutes in
      the 1st session to 30 minutes in the 5th session.

      Session Specific Practices

      In addition to these common elements, each session included a theme and other specific
      mindfulness practices as follows:

        -  Session 1- Theme: Introduction to mindfulness. This session included definition of
           mindfulness and its foundations (Kabat-Zin, 1992), mindful breathing and body scan.

        -  Session 2- Theme: Enhancing Awareness & Focused Attention. This session included
           mindfulness of sounds, a short body scan, mindful breathing, and mindful eating, i.e.
           the "raisin exercise" (ref). In addition, a discussion of mindful consumption and its
           relevance to self-care was explored (Ameli 2013).

        -  Session 3 -Theme: Awareness of pleasurable experiences. This session included
           mindfulness of the breath (briefly incorporating sounds, body sensation, thoughts,
           feelings and then focusing on the breath), and mindful walking. The importance of
           awareness of pleasurable experiences were discussed and an exercise to enhance attention
           to pleasurable experiences was performed in dyads (Ameli 2013).

        -  Session 4- Theme: Transformation of difficult emotions through mindfulness. In this
           session the concept of transforming difficult emotions through the practice of
           mindfulness was discussed, explored, and practiced. The acronym RAIN (recognize,
           accept/allow, investigate, and non-identification) was utilized to facilitate this
           practice.

        -  Session 5- Theme: Compassion. This session mindful breathing and a general discussion of
           compassion, compassion towards self and other, and the practice of loving kindness
           (Ameli 2013). The class was concluded with a "check-out" where participants briefly
           shared their overall experiences and learnings and their goals/vision for future
           self-care activities and practices.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are allocated into the mindfulness-based self-care group or a wait list group for 5 weeks. Since the group is offered during work hours, the waitlist group could be best described as "life as usual". After group allocation, all participants completed demographic and self report clinical assessments at baseline, and self report clinical assessments at follow-up.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Perceived Stress Scale (PSS)
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).
measure: Mindful Attention Awareness Scale (MAAS) - Trait Version
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: The Mindful Attention Awareness Scale-Trait Version (MAAS-T) is used to assess self-reported trait mindfulness. It is a 15-item scale, with a total range from 0 (low mindfulness) to 90 (high mindfulness).
measure: Mindful Attention Awareness Scale (MAAS) - State Version
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: The Mindful Attention Awareness Scale-State Version (MAAS-S) is used to assess self-reported state mindfulness. It is a 5-item scale, with a total range from 0 (high mindfulness) to 30 (low mindfulness).
measure: Positive Affect Scores (PANAS)
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).
These are the Positive Affect Scores
measure: Visual Analog Scale-Anxiety (VAS-A)
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: Visual Analog Scale-Anxiety (VAS-A) is used to assess self-reported anxiety. It is a 1-item scale, with a total range from 1 (low anxiety) to 10 (high anxiety).
measure: Mindful Self Care Scale-General (MSCS-G)
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: Mindful Self Care Scale-General (MSCS-G) is used to assess self-reported mindful self care. It is a 3-item scale, with a total range from 0 (low self care) to 12 (high self care).
measure: Maslach Burnout Inventory (MBI)
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: The Maslach Burnout Inventory (MBI 2-Item) is used to assess self-reported burnout. The 2-Item inventory assesses emotional exhaustion (Item-1) and depersonalization (Item-2) separately from 1 (no symptoms) to 7 (highest severity).
measure: Negative Affect Scores (PANAS)
time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
description: The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).
These are the Negative Affect Scores
arm group label: Mindfulness-based self-care
arm group type: Experimental
description: Mindfulness-based self-care (5 weeks)
arm group label: Life as usual control
arm group type: No Intervention
description: Life as usual control (5 weeks)
intervention type: Behavioral
intervention name: Mindfulness-based self care
description: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
arm group label: Mindfulness-based self-care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rezvan Ameli, PhD
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
facility: 
country: United States
citation: Ameli, R. (2013). 25 Lessons in Mindfulness : Now Time for Healthy Living (First edition. ed.). Washington, D.C.: American Psychological Association.
citation: Krasner MS, Epstein RM, Beckman H, Suchman AL, Chapman B, Mooney CJ, Quill TE. Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians. JAMA. 2009 Sep 23;302(12):1284-93. doi: 10.1001/jama.2009.1384.
PMID: 19773563
citation: de Vibe M, Solhaug I, Rosenvinge JH, Tyssen R, Hanley A, Garland E. Six-year positive effects of a mindfulness-based intervention on mindfulness, coping and well-being in medical and psychology students; Results from a randomized controlled trial. PLoS One. 2018 Apr 24;13(4):e0196053. doi: 10.1371/journal.pone.0196053. eCollection 2018.
PMID: 29689081
citation: West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.
PMID: 27692469
citation: Dyrbye LN, Shanafelt TD. Physician burnout: a potential threat to successful health care reform. JAMA. 2011 May 18;305(19):2009-10. doi: 10.1001/jama.2011.652. No abstract available.
PMID: 21586718
citation: West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.
PMID: 24515493
responsible party type: Principal Investigator
investigator affiliation: National Institutes of Health Clinical Center (CC)
investigator full name: Rezvan Ameli
investigator title: Principal Investigator
mesh term: Occupational Stress
mesh term: Stress, Psychological
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 