<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/NCT02241070</url>
  </required_header>
  <id_info>
    <org_study_id>CCH 110606</org_study_id>
    <nct_id>NCT02241070</nct_id>
  </id_info>
  <brief_title>The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion</brief_title>
  <official_title>The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chung Shan Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chung Shan Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas&#xD;
      a workplace health promotion program on psychological distress, prolonged fatigue, job strain&#xD;
      (job control and job demand), and perceived stress and to explore the influences of personal&#xD;
      characteristics (including gender, age, education, and occupation) on the outcomes of the&#xD;
      intervention with time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was one component of the Taiwan Workplace Mental Health Promotion Scheme. The&#xD;
      study adopted a study design of a randomized controlled trial. Two large-scale manufacturing&#xD;
      factories were chosen for this study. All of the factories' 3270 full-time employees were&#xD;
      requested to fill in a questionnaire comprising questions regarding mental health and job&#xD;
      strain. Of these employees, 2849 individuals were willing to complete the questionnaire. A&#xD;
      total of 431 employees (15.13%) were found to be in psychological distress with job strain.&#xD;
      The screening procedure was carried out between June and July in 2011. A letter of invitation&#xD;
      with an introduction to MBI was sent to these employees. Of these 431 employees, only 144&#xD;
      responded that they would be willing to take part voluntarily in the study. These 144 workers&#xD;
      were allocated randomly into the intervention group (Group I, n=72) or the waiting-list&#xD;
      control group (Group C, n=72).&#xD;
&#xD;
      All the participants were measured five times with an interval of four weeks between&#xD;
      measurements. These measurements were taken at pre-intervention (T1), at mid-intervention&#xD;
      (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight&#xD;
      weeks after intervention (T5). The data related with the effectiveness of the intervention&#xD;
      were obtained between August and December in 2011.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>psychological distress</measure>
    <time_frame>four months</time_frame>
    <description>Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prolonged fatigue</measure>
    <time_frame>Four months</time_frame>
    <description>Prolonged fatigue was measured by The Checklist Individual Strength questionnaire (CIS), which confirmed discriminant validity and convergent validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>job strain</measure>
    <time_frame>four months</time_frame>
    <description>The Job Content Questionnaire (JCQ) was used to assess job control and job demands (job strain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perceived stress</measure>
    <time_frame>four months</time_frame>
    <description>The 10-item Perceived Stress Scale (PSS-10) was adopted to measure a global level of perceived stress.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>mindulness-based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindulness-based intervention was eight weeks of mindfulness training with forty-five minutes of homework practice every day during the training course. A leader and a professional facilitator led the group. The leader was a long-term mindfulness and vipassana meditation trainer who had practiced both types of meditation for more than two decades and had completed mindfulness trainer education; the professional facilitator was a mindfulness practitioner and a psychiatrist. The group met weekly for two hours in-session at the workplace.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>waiting-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>passive control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mindulness-based intervention</intervention_name>
    <description>A number of mindfulness techniques, including both &quot;formal&quot; and &quot;informal&quot; practices with integration in the context of Mind/Body meditation, were explored in order to cultivate moment-by-moment present awareness with non-judgmental acceptance.</description>
    <arm_group_label>mindulness-based intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy employees with psychological distress and job strain&#xD;
&#xD;
          -  Full-time paid workers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18y or &gt; 65y&#xD;
&#xD;
          -  Part-time workers&#xD;
&#xD;
          -  The workers are not willing to take part in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feng-Cheng Tang, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chung Shan Medical University</name>
      <address>
        <city>Taichung</city>
        <zip>402</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chung Shan Medical University</investigator_affiliation>
    <investigator_full_name>GCRC</investigator_full_name>
    <investigator_title>Chung Shan Medical University</investigator_title>
  </responsible_party>
  <keyword>mindfulness meditation</keyword>
  <keyword>mental health promotion</keyword>
  <keyword>worker</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/NCT02241070
org study id: CCH 110606
nct id: NCT02241070
lead sponsor: 
collaborator: 
has dmc: Yes
The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas
      a workplace health promotion program on psychological distress, prolonged fatigue, job strain
      (job control and job demand), and perceived stress and to explore the influences of personal
      characteristics (including gender, age, education, and occupation) on the outcomes of the
      intervention with time.
This study was one component of the Taiwan Workplace Mental Health Promotion Scheme. The
      study adopted a study design of a randomized controlled trial. Two large-scale manufacturing
      factories were chosen for this study. All of the factories' 3270 full-time employees were
      requested to fill in a questionnaire comprising questions regarding mental health and job
      strain. Of these employees, 2849 individuals were willing to complete the questionnaire. A
      total of 431 employees (15.13%) were found to be in psychological distress with job strain.
      The screening procedure was carried out between June and July in 2011. A letter of invitation
      with an introduction to MBI was sent to these employees. Of these 431 employees, only 144
      responded that they would be willing to take part voluntarily in the study. These 144 workers
      were allocated randomly into the intervention group (Group I, n=72) or the waiting-list
      control group (Group C, n=72).

      All the participants were measured five times with an interval of four weeks between
      measurements. These measurements were taken at pre-intervention (T1), at mid-intervention
      (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight
      weeks after intervention (T5). The data related with the effectiveness of the intervention
      were obtained between August and December in 2011.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: psychological distress
time frame: four months
description: Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument
measure: prolonged fatigue
time frame: Four months
description: Prolonged fatigue was measured by The Checklist Individual Strength questionnaire (CIS), which confirmed discriminant validity and convergent validity.
measure: job strain
time frame: four months
description: The Job Content Questionnaire (JCQ) was used to assess job control and job demands (job strain).
measure: perceived stress
time frame: four months
description: The 10-item Perceived Stress Scale (PSS-10) was adopted to measure a global level of perceived stress.
arm group label: mindulness-based intervention
arm group type: Experimental
description: Mindulness-based intervention was eight weeks of mindfulness training with forty-five minutes of homework practice every day during the training course. A leader and a professional facilitator led the group. The leader was a long-term mindfulness and vipassana meditation trainer who had practiced both types of meditation for more than two decades and had completed mindfulness trainer education; the professional facilitator was a mindfulness practitioner and a psychiatrist. The group met weekly for two hours in-session at the workplace.
arm group label: waiting-list control
arm group type: No Intervention
description: passive control group
intervention type: Behavioral
intervention name: mindulness-based intervention
description: A number of mindfulness techniques, including both "formal" and "informal" practices with integration in the context of Mind/Body meditation, were explored in order to cultivate moment-by-moment present awareness with non-judgmental acceptance.
arm group label: mindulness-based intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Feng-Cheng Tang, MD; PhD
role: Principal Investigator
affiliation: Changhua Christian Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chung Shan Medical University
investigator full name: GCRC
investigator title: Chung Shan Medical University