<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/NCT03756701</url>
  </required_header>
  <id_info>
    <org_study_id>157-18</org_study_id>
    <nct_id>NCT03756701</nct_id>
  </id_info>
  <brief_title>Mind Body Interventions for the Student Population</brief_title>
  <official_title>Mind Body Interventions for the Student Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Youngstown State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Youngstown State University</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>
      This crossover randomized design study's objective is to see if mind body interventions can&#xD;
      help students on a college campus manage their chronic pain and/or PTSD. Participants will&#xD;
      attend 10 mind body skills group sessions that are 2 hours each. These group sessions teach a&#xD;
      variety of ways (skills) for people to express their feelings. A licensed doctor, who is&#xD;
      certified to teach mind-body skills group classes, will lead the skills group. Participants&#xD;
      will be assessed with an anxiety questionnaire, a chronic pain measure and a measure of heart&#xD;
      rate variability.&#xD;
&#xD;
      There will be two groups. Group 1 will begin intervention after baseline testing and will&#xD;
      receive follow-up skill sessions once every month for 6 months. The first group will also&#xD;
      attend bonus classes during the next 6 months. The second group will do baseline testing and&#xD;
      no intervention for the first 10 weeks. They will then participate in the skills groups the&#xD;
      second 10 weeks. There will be 3,6 and 12 month follow up data also taken.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Students on campus will be made aware of the study through fliers posted on campus. If they&#xD;
      contact the study representatives to participate, they will fill out a screening&#xD;
      questionnaire that will determine their symptoms and care they are currently receiving. Those&#xD;
      that meet the inclusion criteria will be assigned to Group 1 or 2 randomly. The mind body&#xD;
      skills groups will be 10 weeks long. Group 1 will participate in mind body interventions&#xD;
      immediately, and Group 2 will continue with their usual care for the 10 weeks. After the&#xD;
      first session, Group 2 will complete the mind body intervention sessions. The research will&#xD;
      therefore be a crossover randomized design where each group will serve as its own control,&#xD;
      and also may be compared to the other group. Participants in either group will still be&#xD;
      allowed to participate in any care they are currently receiving outside of the mind body&#xD;
      intervention, including but not limited to counseling or a support group or therapy. Also,&#xD;
      after these groups are over, the first group will continue to have &quot;reunion groups&quot; once per&#xD;
      month for 6 months and the second group will not. Reunion groups will consist of&#xD;
      supplementary mind body skills group sessions that reinforce skills learned in the original&#xD;
      mind body skills groups and also work on retention of knowledge beyond the program. Outcome&#xD;
      measures will be taken pre and post mind body skills group, and then at 3, 6, and 12 months&#xD;
      after the 10 week mind body skills group ends.&#xD;
&#xD;
      The topics for each session is based upon the Centers for Mind Body Medicine model. Both&#xD;
      groups will follow this same weekly topic schedule.&#xD;
&#xD;
        1. Introduction and Drawings&#xD;
&#xD;
        2. Autogenic Training and Biofeedback&#xD;
&#xD;
        3. Guided Imagery&#xD;
&#xD;
        4. Meditation&#xD;
&#xD;
        5. Mobilizing, Transforming, and Celebrating Emotion&#xD;
&#xD;
        6. Genograms part 1&#xD;
&#xD;
        7. Genograms part 2&#xD;
&#xD;
        8. Mindful Eating and Healthy Nutrition&#xD;
&#xD;
        9. Spirituality&#xD;
&#xD;
       10. Closing Drawings and Ritual&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>There will be 2 groups of participants. Group 1 will begin the intervention immediately. Group 2 will maintain their usual lifestyle for the first 10 weeks, and begin group sessions when group 1 has completed. There will be &quot;refresher sessions&quot; for group 1 once per month, and 3, 6 12 month follow up testing after the group sessions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC)</measure>
    <time_frame>Pre intervention, post intervention, 3,6,12 month followup</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Graded Chronic Pain Scale</measure>
    <time_frame>Pre intervention, post intervention, 3,6,12 month followup</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient Health Questionnaire - 9 (PHQ 9),</measure>
    <time_frame>Pre intervention, post intervention, 3,6,12 month followup</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Five Facet Mindfulness Questionnaire - 15 (FFMQ - 15)</measure>
    <time_frame>Pre intervention, post intervention, 3,6,12 month followup</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Heart rate variability</measure>
    <time_frame>Pre intervention, post intervention, at the start of each session, 3,6,12 month followup</time_frame>
    <description>Measure of heart rate change over time taken with an ap on a cell phone.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Anxiety</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial participants in the 10 mind body sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 week no intervention groups - receives the mind body interventions after group 1 has completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mind body skills</intervention_name>
    <description>2 hour skill sessions that focus on mindfulness: The topics for each session is based upon the Centers for Mind Body Medicine model. Both groups will follow this same weekly topic schedule.&#xD;
Introduction and Drawings&#xD;
Autogenic Training and Biofeedback&#xD;
Guided Imagery&#xD;
Meditation&#xD;
Mobilizing, Transforming, and Celebrating Emotion&#xD;
Genograms part 1&#xD;
Genograms part 2&#xD;
Mindful Eating and Healthy Nutrition&#xD;
Spirituality&#xD;
Closing Drawings and Ritual</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Selection criteria includes:&#xD;
&#xD;
        Students aged 18-65 who own a smartphone that is able to download the HRV4Training app.&#xD;
&#xD;
        Students must be enrolled in graduate or undergraduate classes on Youngstown State&#xD;
        University's campus.&#xD;
&#xD;
        Exclusion Criteria: students that have had previous experience with mind body skills groups&#xD;
        or stress reduction interventions within the past 12 months.&#xD;
&#xD;
        -&#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>Nancy Landgraff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Youngstown State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Youngstown State University</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ptsd.va.gov/public/PTSD-overview/basics/how-common-is-ptsd.asp</url>
    <description>website</description>
  </link>
  <link>
    <url>https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd</url>
    <description>website</description>
  </link>
  <reference>
    <citation>Brennstuhl MJ, Tarquinio C, Montel S. Chronic Pain and PTSD: Evolving Views on Their Comorbidity. Perspect Psychiatr Care. 2015 Oct;51(4):295-304. doi: 10.1111/ppc.12093. Epub 2014 Nov 24.</citation>
    <PMID>25420926</PMID>
  </reference>
  <reference>
    <citation>Libby DJ, Pilver CE, Desai R. Complementary and Alternative Medicine Use Among Individuals with Posttraumatic Stress Disorder. Psychol Trauma. 2013;5: 277-285.</citation>
  </reference>
  <reference>
    <citation>Robert-McComb JJ, Cisneros A, Tacon A, Panike R, Norman R, Qian XP, McGlone J. The Effects of Mindfulness-Based Movement on Parameters of Stress. Int J Yoga Therap. 2015;25(1):79-88. doi: 10.17761/1531-2054-25.1.79.</citation>
    <PMID>26667291</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Youngstown State University</investigator_affiliation>
    <investigator_full_name>Nancy Landgraff</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</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/NCT03756701
org study id: 157-18
nct id: NCT03756701
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This crossover randomized design study's objective is to see if mind body interventions can
      help students on a college campus manage their chronic pain and/or PTSD. Participants will
      attend 10 mind body skills group sessions that are 2 hours each. These group sessions teach a
      variety of ways (skills) for people to express their feelings. A licensed doctor, who is
      certified to teach mind-body skills group classes, will lead the skills group. Participants
      will be assessed with an anxiety questionnaire, a chronic pain measure and a measure of heart
      rate variability.

      There will be two groups. Group 1 will begin intervention after baseline testing and will
      receive follow-up skill sessions once every month for 6 months. The first group will also
      attend bonus classes during the next 6 months. The second group will do baseline testing and
      no intervention for the first 10 weeks. They will then participate in the skills groups the
      second 10 weeks. There will be 3,6 and 12 month follow up data also taken.
Students on campus will be made aware of the study through fliers posted on campus. If they
      contact the study representatives to participate, they will fill out a screening
      questionnaire that will determine their symptoms and care they are currently receiving. Those
      that meet the inclusion criteria will be assigned to Group 1 or 2 randomly. The mind body
      skills groups will be 10 weeks long. Group 1 will participate in mind body interventions
      immediately, and Group 2 will continue with their usual care for the 10 weeks. After the
      first session, Group 2 will complete the mind body intervention sessions. The research will
      therefore be a crossover randomized design where each group will serve as its own control,
      and also may be compared to the other group. Participants in either group will still be
      allowed to participate in any care they are currently receiving outside of the mind body
      intervention, including but not limited to counseling or a support group or therapy. Also,
      after these groups are over, the first group will continue to have "reunion groups" once per
      month for 6 months and the second group will not. Reunion groups will consist of
      supplementary mind body skills group sessions that reinforce skills learned in the original
      mind body skills groups and also work on retention of knowledge beyond the program. Outcome
      measures will be taken pre and post mind body skills group, and then at 3, 6, and 12 months
      after the 10 week mind body skills group ends.

      The topics for each session is based upon the Centers for Mind Body Medicine model. Both
      groups will follow this same weekly topic schedule.

        1. Introduction and Drawings

        2. Autogenic Training and Biofeedback

        3. Guided Imagery

        4. Meditation

        5. Mobilizing, Transforming, and Celebrating Emotion

        6. Genograms part 1

        7. Genograms part 2

        8. Mindful Eating and Healthy Nutrition

        9. Spirituality

       10. Closing Drawings and Ritual
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: There will be 2 groups of participants. Group 1 will begin the intervention immediately. Group 2 will maintain their usual lifestyle for the first 10 weeks, and begin group sessions when group 1 has completed. There will be "refresher sessions" for group 1 once per month, and 3, 6 12 month follow up testing after the group sessions.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Post Traumatic Stress Disorder Checklist - Civilian (PCLC)
time frame: Pre intervention, post intervention, 3,6,12 month followup
description: Questionnaire
measure: Change in Graded Chronic Pain Scale
time frame: Pre intervention, post intervention, 3,6,12 month followup
description: Questionnaire
measure: Change in Patient Health Questionnaire - 9 (PHQ 9),
time frame: Pre intervention, post intervention, 3,6,12 month followup
description: Questionnaire
measure: Change in Five Facet Mindfulness Questionnaire - 15 (FFMQ - 15)
time frame: Pre intervention, post intervention, 3,6,12 month followup
description: Questionnaire
measure: Change in Heart rate variability
time frame: Pre intervention, post intervention, at the start of each session, 3,6,12 month followup
description: Measure of heart rate change over time taken with an ap on a cell phone.
arm group label: Group 1
arm group type: Experimental
description: Initial participants in the 10 mind body sessions
arm group label: Group 2
arm group type: Active Comparator
description: 10 week no intervention groups - receives the mind body interventions after group 1 has completed.
intervention type: Behavioral
intervention name: Mind body skills
description: 2 hour skill sessions that focus on mindfulness: The topics for each session is based upon the Centers for Mind Body Medicine model. Both groups will follow this same weekly topic schedule.
Introduction and Drawings
Autogenic Training and Biofeedback
Guided Imagery
Meditation
Mobilizing, Transforming, and Celebrating Emotion
Genograms part 1
Genograms part 2
Mindful Eating and Healthy Nutrition
Spirituality
Closing Drawings and Ritual
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy Landgraff, PhD
role: Principal Investigator
affiliation: Youngstown State University
facility: 
country: United States
url: https://www.ptsd.va.gov/public/PTSD-overview/basics/how-common-is-ptsd.asp
description: website
url: https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd
description: website
citation: Brennstuhl MJ, Tarquinio C, Montel S. Chronic Pain and PTSD: Evolving Views on Their Comorbidity. Perspect Psychiatr Care. 2015 Oct;51(4):295-304. doi: 10.1111/ppc.12093. Epub 2014 Nov 24.
PMID: 25420926
citation: Libby DJ, Pilver CE, Desai R. Complementary and Alternative Medicine Use Among Individuals with Posttraumatic Stress Disorder. Psychol Trauma. 2013;5: 277-285.
citation: Robert-McComb JJ, Cisneros A, Tacon A, Panike R, Norman R, Qian XP, McGlone J. The Effects of Mindfulness-Based Movement on Parameters of Stress. Int J Yoga Therap. 2015;25(1):79-88. doi: 10.17761/1531-2054-25.1.79.
PMID: 26667291
responsible party type: Principal Investigator
investigator affiliation: Youngstown State University
investigator full name: Nancy Landgraff
investigator title: Professor
mesh term: Chronic Pain
sharing ipd: No