<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/NCT02191345</url>
  </required_header>
  <id_info>
    <org_study_id>MD002265</org_study_id>
    <secondary_id>IRB-2014-743</secondary_id>
    <nct_id>NCT02191345</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Guided Imagery for a Nonprofit's Employees</brief_title>
  <official_title>A Randomized Controlled Trial Measuring the Effectiveness of Prerecorded Guided Imagery in Reducing Compassion Fatigue, Burnout, Perceived Stress, and State Anxiety of a Mental Health Nonprofit's Employees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FrontLine Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>FrontLine Service</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Aim A. To determine if listening to prerecorded guided imagery 3 times per week for 4&#xD;
      weeks will reduce state anxiety, perceived stress, burnout, compassion fatigue, and vicarious&#xD;
      trauma in Fronltine Service staff.&#xD;
&#xD;
      Primary Aim B. To determine if staff will continue to listen to guided imagery after the&#xD;
      first 4 weeks of the study is over.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the change in stress levels of employees who listen&#xD;
      to prerecorded guided imagery to employees who take breaks, and to determine if employees are&#xD;
      likely to adopt prerecorded guided imagery as a self-care tool.&#xD;
&#xD;
      Participants will be randomly assigned to either the guided imagery group or the control&#xD;
      group. Members of the control group will be asked to take a 10 minute break 3 times per week&#xD;
      for 4 weeks. Members of the guided imagery group will be asked to listen to one prerecorded&#xD;
      guided imagery track 3 times per week for 4 weeks. All participants will fill out&#xD;
      questionnaires before and after the 4 week period. All participants will fill out a short&#xD;
      form before and after listening to each guided imagery, or before and after taking each&#xD;
      break.&#xD;
&#xD;
      Phase 2: After phase 1 is complete, all participants will have the option to participate in&#xD;
      phase 2 of the study. During phase 2, participants will receive a calendar and put a mark on&#xD;
      every day that they listen to a guided imagery track. At the end of 4 weeks, participants&#xD;
      will turn in the calendar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>State Anxiety as Measured by the State Anxiety Short Form</measure>
    <time_frame>4 weeks</time_frame>
    <description>Participants in the experimental group will fill out the State Anxiety Short Form, a 6-item questionnaire before and after listening to guided imagery. Participants in the control group will fill out the same measure before and after taking a break.&#xD;
This will be done 3 times per week for a duration of 4 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compassion Fatigue, Compassion Satisfaction, and Burnout, as measured by the ProQol</measure>
    <time_frame>4 weeks</time_frame>
    <description>Participants in both the control and experimental groups will complete the ProQol, a 30-item questionnaire, before and after the 4-week intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress as measured by the Perceived Stress Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Participants in the experimental and control groups will complete the Perceived Stress Scale, a self-report, 10-item questionnaire, before and after the 4-week intervention period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Focus of Study</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>10 minute break</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants asked to take a 10 minute break as usual 3 times per week for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guided Imagery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants listen to one of 6 pre-recorded guided imagery tracks 3 times per week for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Guided Imagery</intervention_name>
    <description>Guided imagery is a stress management technique that uses verbal suggestion and descriptive language to guide the listener into imagining sensations and visualizing images in the mind in order to bring about a desired physical response, such as reduction in anxiety, stress, or pain. The guided imagery tracks chosen for the study were chosen because their goal is relaxation and stress relief, and their length is under 15 minutes.</description>
    <arm_group_label>Guided Imagery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Staff of a nonprofit who work a minimum of three shifts per week&#xD;
&#xD;
          -  Willing and able to use about 8-15 minutes of their lunch hours three times per week&#xD;
             for for four weeks for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Staff members will be excluded from the study if they currently listen to guided&#xD;
             imagery&#xD;
&#xD;
          -  Those currently experiencing drug or alcohol abuse, suicidal ideation, or other&#xD;
             serious mental health issue while not under the care of a trained mental health&#xD;
             professional will also be excluded&#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>Ashwini Sehgal, MD</last_name>
    <role>Study Director</role>
    <affiliation>Case Western Reserve University, MetroHealth Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kimberly A Juhas, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>FrontLine Service</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FrontLine Service</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 18, 2017</last_update_submitted>
  <last_update_submitted_qc>February 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>FrontLine Service</investigator_affiliation>
    <investigator_full_name>Kimberly Juhas</investigator_full_name>
    <investigator_title>Community Research Scholar</investigator_title>
  </responsible_party>
  <keyword>guided imagery</keyword>
  <keyword>burnout</keyword>
  <keyword>compassion fatigue</keyword>
  <keyword>state anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compassion Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02191345
org study id: MD002265
secondary id: IRB-2014-743
nct id: NCT02191345
lead sponsor: 
collaborator: 
has dmc: Yes
Primary Aim A. To determine if listening to prerecorded guided imagery 3 times per week for 4
      weeks will reduce state anxiety, perceived stress, burnout, compassion fatigue, and vicarious
      trauma in Fronltine Service staff.

      Primary Aim B. To determine if staff will continue to listen to guided imagery after the
      first 4 weeks of the study is over.
The purpose of this study is to compare the change in stress levels of employees who listen
      to prerecorded guided imagery to employees who take breaks, and to determine if employees are
      likely to adopt prerecorded guided imagery as a self-care tool.

      Participants will be randomly assigned to either the guided imagery group or the control
      group. Members of the control group will be asked to take a 10 minute break 3 times per week
      for 4 weeks. Members of the guided imagery group will be asked to listen to one prerecorded
      guided imagery track 3 times per week for 4 weeks. All participants will fill out
      questionnaires before and after the 4 week period. All participants will fill out a short
      form before and after listening to each guided imagery, or before and after taking each
      break.

      Phase 2: After phase 1 is complete, all participants will have the option to participate in
      phase 2 of the study. During phase 2, participants will receive a calendar and put a mark on
      every day that they listen to a guided imagery track. At the end of 4 weeks, participants
      will turn in the calendar.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: State Anxiety as Measured by the State Anxiety Short Form
time frame: 4 weeks
description: Participants in the experimental group will fill out the State Anxiety Short Form, a 6-item questionnaire before and after listening to guided imagery. Participants in the control group will fill out the same measure before and after taking a break.
This will be done 3 times per week for a duration of 4 weeks.
measure: Compassion Fatigue, Compassion Satisfaction, and Burnout, as measured by the ProQol
time frame: 4 weeks
description: Participants in both the control and experimental groups will complete the ProQol, a 30-item questionnaire, before and after the 4-week intervention period.
measure: Perceived Stress as measured by the Perceived Stress Scale
time frame: 4 weeks
description: Participants in the experimental and control groups will complete the Perceived Stress Scale, a self-report, 10-item questionnaire, before and after the 4-week intervention period.
arm group label: 10 minute break
arm group type: No Intervention
description: Participants asked to take a 10 minute break as usual 3 times per week for 4 weeks
arm group label: Guided Imagery
arm group type: Experimental
description: Participants listen to one of 6 pre-recorded guided imagery tracks 3 times per week for 4 weeks
intervention type: Behavioral
intervention name: Guided Imagery
description: Guided imagery is a stress management technique that uses verbal suggestion and descriptive language to guide the listener into imagining sensations and visualizing images in the mind in order to bring about a desired physical response, such as reduction in anxiety, stress, or pain. The guided imagery tracks chosen for the study were chosen because their goal is relaxation and stress relief, and their length is under 15 minutes.
arm group label: Guided Imagery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ashwini Sehgal, MD
role: Study Director
affiliation: Case Western Reserve University, MetroHealth Medical Center
last name: Kimberly A Juhas, MA
role: Principal Investigator
affiliation: FrontLine Service
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: FrontLine Service
investigator full name: Kimberly Juhas
investigator title: Community Research Scholar
mesh term: Compassion Fatigue
sharing ipd: No