<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/NCT02194478</url>
  </required_header>
  <id_info>
    <org_study_id>S091301</org_study_id>
    <nct_id>NCT02194478</nct_id>
  </id_info>
  <brief_title>Stress Reduction for Busy Professionals</brief_title>
  <official_title>Pilot Study of a Brief Mind/Body Meditation Intervention for Allina Health Employees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allina Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allina Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week&#xD;
      mind-body/meditation intervention on self-reported quality of life in individuals employed by&#xD;
      Allina Health. Outcomes will include validated questionnaires for depressive symptomology,&#xD;
      perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes&#xD;
      of salivary cortisol for a sub-sample of employees.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived stress change from baseline at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Perceived stress will be measured through the Perceived Stress Scale at baseline and week 8.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Salivary Cortisol Levels Change from baseline at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Salivary samples will be obtained at baseline and week 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle Profile change from baseline at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Lifestyle Profile questionnaire measures self actualization, health responsibility, exercise, nutrition, interpersonal support, and stress management. It will be administered at baseline and week 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work productivity and activity impairment change from baseline at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Work productivity and activity impairment will be measured through the WPAI:GH and will be administered at baseline and week 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Promis-29 score change from baseline at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Promis-29 is a 29 item questionnaire measuring physical function, fatigue, pain, depression, anxiety, and social role participation. The questionnaire will be administered at baseline and week 8.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>8 Week Meditation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Allina Health employees undergoing 8 week meditation intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meditation</intervention_name>
    <description>30 minute, 8 week meditation</description>
    <arm_group_label>8 Week Meditation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 to 65 years&#xD;
&#xD;
          -  Actively-working healthcare professional employed by Allina Health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in an Allina Health stress reduction program&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffery Dusek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allina Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allina Health</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>August 31, 2016</last_update_submitted>
  <last_update_submitted_qc>August 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Meditation</keyword>
  <keyword>Mind body</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02194478
org study id: S091301
nct id: NCT02194478
lead sponsor: 
has dmc: No
This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week
      mind-body/meditation intervention on self-reported quality of life in individuals employed by
      Allina Health. Outcomes will include validated questionnaires for depressive symptomology,
      perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes
      of salivary cortisol for a sub-sample of employees.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Perceived stress change from baseline at week 8
time frame: Baseline, Week 8
description: Perceived stress will be measured through the Perceived Stress Scale at baseline and week 8.
measure: Salivary Cortisol Levels Change from baseline at week 8
time frame: Baseline, Week 8
description: Salivary samples will be obtained at baseline and week 8.
measure: Lifestyle Profile change from baseline at week 8
time frame: Baseline, Week 8
description: The Lifestyle Profile questionnaire measures self actualization, health responsibility, exercise, nutrition, interpersonal support, and stress management. It will be administered at baseline and week 8.
measure: Work productivity and activity impairment change from baseline at week 8
time frame: Baseline, Week 8
description: Work productivity and activity impairment will be measured through the WPAI:GH and will be administered at baseline and week 8.
measure: Promis-29 score change from baseline at week 8
time frame: Baseline, Week 8
description: The Promis-29 is a 29 item questionnaire measuring physical function, fatigue, pain, depression, anxiety, and social role participation. The questionnaire will be administered at baseline and week 8.
arm group label: 8 Week Meditation
arm group type: Other
description: Allina Health employees undergoing 8 week meditation intervention
intervention type: Behavioral
intervention name: Meditation
description: 30 minute, 8 week meditation
arm group label: 8 Week Meditation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffery Dusek, PhD
role: Principal Investigator
affiliation: Allina Health
facility: 
country: United States
responsible party type: Sponsor