<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/NCT01717547</url>
  </required_header>
  <id_info>
    <org_study_id>12-0641</org_study_id>
    <nct_id>NCT01717547</nct_id>
  </id_info>
  <brief_title>Strength and Awareness in Action</brief_title>
  <official_title>Strength and Awareness in Action</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Eastern Colorado Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Eastern Colorado Health Care System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this research study are to 1) assess the acceptability and feasibility of&#xD;
      conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs&#xD;
      Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on&#xD;
      Veteran's mental health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since October of 2001, approximately over 2 million troops have been deployed in the Global&#xD;
      War on Terror. Many service members are returning with both physical injuries and mental&#xD;
      health conditions. High rates of both post traumatic stress disorder (PTSD) and/or mild&#xD;
      traumatic brain injury (mTBI) and associated symptoms have been noted. It has been estimated&#xD;
      that approximately 18-20% of returning service members meet criteria for PTSD and that 11-23%&#xD;
      of veterans have a history of mTBI. It has been well established in the research literature&#xD;
      that these two conditions frequently co-occur. While there is a dearth of evidence-based&#xD;
      treatment for co-occurring PTSD and mTBI, it has been suggested that best practices entail&#xD;
      treating presenting symptoms (hyperarousal, hypo-arousal, emotional reactivity, irritability,&#xD;
      depression, anxiety, concentration problems) regardless of etiology. Yoga may be particularly&#xD;
      well-suited to treating returning servicemen as data suggests that core symptoms that develop&#xD;
      with a history of trauma exposure (e.g: hyperarousal; hypoarousal; emotional reactivity;&#xD;
      anxiety, irritability), are physiologically based, somatically experienced and often not&#xD;
      amenable to change through talking alone. In addition, yoga may assist with dysregulation&#xD;
      often associated with mental health and physical conditions, and facilitate the development&#xD;
      of mindfulness skills. Research suggests that that moment-to-moment awareness of present&#xD;
      experience may decrease emotional reactivity and anxiety, and increase the capacity for&#xD;
      self-regulation. Mindfulness skills have also been associated with: building resilience in&#xD;
      the midst of stress; allowing one to better cope with physical discomfort; decreasing anxiety&#xD;
      and depression; decreasing reactivity. All of these areas are relevant to improving the&#xD;
      health and well-being of Veterans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</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>Change in Psychological Distress</measure>
    <time_frame>Change from baseline to approximately 8 weeks</time_frame>
    <description>Change in OQ 45 Scores pre and post intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Acceptability</measure>
    <time_frame>Change in baseline up to 8 weeks post</time_frame>
    <description>To assess participant satisfaction post-intervention using the Client Satisfaction Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Stress Disorders</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yoga-based treatment - manualized group treatment - classes will be held twice per week for approximately 85 minutes for a period of eight weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga-based treatment</intervention_name>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans receiving care by a primary care provider at DVAMC&#xD;
&#xD;
          -  Between the ages of 18 and 50&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Able to adequately answer comprehension questions&#xD;
&#xD;
          -  Documented VA primary care provider medical clearance to participate in the study as&#xD;
             noted on the medical clearance form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Veterans younger than 18, or older than 50 years of age&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Inability to answer comprehension questions&#xD;
&#xD;
          -  Meet criteria for active substance dependence, excluding Cannabis dependence as&#xD;
             determined by clinical interview&#xD;
&#xD;
          -  Identification of active psychosis as determined by clinical interview&#xD;
&#xD;
          -  Documentation on the medical clearance form by VA primary care provider which suggests&#xD;
             barriers to Veteran participation&#xD;
&#xD;
          -  Veterans whom have sustained an amputation and/or whom have limited physical mobility&#xD;
             as documented by the VA primary care provider&#xD;
&#xD;
          -  Veterans already participating in an ongoing yoga practice of up to two times weekly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Brenner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA ECHCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Veterans Affairs Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mirecc.va.gov/visn19/</url>
    <description>VA VISN 19 MIRECC website</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Eastern Colorado Health Care System</investigator_affiliation>
    <investigator_full_name>Lisa Brenner</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Veterans</keyword>
  <keyword>Yoga</keyword>
  <keyword>Stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01717547
org study id: 12-0641
nct id: NCT01717547
lead sponsor: 
has dmc: No
The aims of this research study are to 1) assess the acceptability and feasibility of
      conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs
      Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on
      Veteran's mental health.
Since October of 2001, approximately over 2 million troops have been deployed in the Global
      War on Terror. Many service members are returning with both physical injuries and mental
      health conditions. High rates of both post traumatic stress disorder (PTSD) and/or mild
      traumatic brain injury (mTBI) and associated symptoms have been noted. It has been estimated
      that approximately 18-20% of returning service members meet criteria for PTSD and that 11-23%
      of veterans have a history of mTBI. It has been well established in the research literature
      that these two conditions frequently co-occur. While there is a dearth of evidence-based
      treatment for co-occurring PTSD and mTBI, it has been suggested that best practices entail
      treating presenting symptoms (hyperarousal, hypo-arousal, emotional reactivity, irritability,
      depression, anxiety, concentration problems) regardless of etiology. Yoga may be particularly
      well-suited to treating returning servicemen as data suggests that core symptoms that develop
      with a history of trauma exposure (e.g: hyperarousal; hypoarousal; emotional reactivity;
      anxiety, irritability), are physiologically based, somatically experienced and often not
      amenable to change through talking alone. In addition, yoga may assist with dysregulation
      often associated with mental health and physical conditions, and facilitate the development
      of mindfulness skills. Research suggests that that moment-to-moment awareness of present
      experience may decrease emotional reactivity and anxiety, and increase the capacity for
      self-regulation. Mindfulness skills have also been associated with: building resilience in
      the midst of stress; allowing one to better cope with physical discomfort; decreasing anxiety
      and depression; decreasing reactivity. All of these areas are relevant to improving the
      health and well-being of Veterans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Psychological Distress
time frame: Change from baseline to approximately 8 weeks
description: Change in OQ 45 Scores pre and post intervention
measure: Change in Acceptability
time frame: Change in baseline up to 8 weeks post
description: To assess participant satisfaction post-intervention using the Client Satisfaction Questionnaire
arm group label: Yoga
arm group type: Experimental
description: Yoga-based treatment - manualized group treatment - classes will be held twice per week for approximately 85 minutes for a period of eight weeks.
intervention type: Behavioral
intervention name: Yoga-based treatment
arm group label: Yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Brenner, PhD
role: Principal Investigator
affiliation: VA ECHCS
facility: 
country: United States
url: http://www.mirecc.va.gov/visn19/
description: VA VISN 19 MIRECC website
responsible party type: Principal Investigator
investigator affiliation: VA Eastern Colorado Health Care System
investigator full name: Lisa Brenner
investigator title: Director
mesh term: Stress Disorders, Traumatic