<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/NCT03277859</url>
  </required_header>
  <id_info>
    <org_study_id>17-0785</org_study_id>
    <nct_id>NCT03277859</nct_id>
  </id_info>
  <brief_title>Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)</brief_title>
  <acronym>SAA-TBI</acronym>
  <official_title>Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Eastern Colorado Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Eastern Colorado Health Care System</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The specific aims of the proposed study are to evaluate: 1) the feasibility of design&#xD;
      elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches&#xD;
      (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention);&#xD;
      2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal&#xD;
      outcomes. Performance of validated measures, including those associated with quality of life,&#xD;
      as well as data collected via ecological momentary assessment and pedometry (physical&#xD;
      activity) will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A signature injury being sustained by Veterans from recent conflicts is mild traumatic brain&#xD;
      injury (mTBI). For some, this condition is associated with multiple disabling post-concussive&#xD;
      symptoms, including post-concussive headaches (PCH). PCHs are notoriously resistant to&#xD;
      medication alone, and are associated with increased muscle tension, avoidance of physical&#xD;
      activities, and anxiety related to having chronic pain. In this study, the feasibility (ease&#xD;
      of implementation) of the design elements of an interventional trial of Strength and&#xD;
      Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) will be explored.&#xD;
      Yoga is operationalized as a practice involving physical postures, breath awareness,&#xD;
      breathing exercises and mindfulness meditation. It is conceptualized as having three &quot;active&#xD;
      ingredients&quot; (i.e., regulation of the autonomic nervous system via physical&#xD;
      activity/breathing exercises, release of muscular tension associated with headaches, and&#xD;
      mindfulness/acceptance). The specific aims of the proposed study are to evaluate: 1) the&#xD;
      feasibility of design elements of an SAA-TBI intervention trial (e.g., an exercise run-in to&#xD;
      facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates&#xD;
      for candidate proximal and distal outcomes. Performance of validated measures, including&#xD;
      those associated with quality of life, as well as data collected via ecological momentary&#xD;
      assessment and pedometry (physical activity) will be evaluated. Project aims will be&#xD;
      evaluated using an experimental design where participants will be block randomized in a&#xD;
      stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will&#xD;
      initially receive 8 weeks of enhanced treatment as usual (ETU). The participants in the&#xD;
      waitlist condition will be offered SAA-TBI, after the initial group has completed the&#xD;
      intervention. Both groups of participants will complete multiple measures at baseline and&#xD;
      after the conclusion of the intervention. Maintenance among the intervention group will also&#xD;
      be explored. Participants will be asked to complete daily homework documenting their&#xD;
      headaches and yoga practice outside of class, and be provided with multiple modalities&#xD;
      (web-based, mobile app, text, or paper and pencil) by which this can be accomplished. In&#xD;
      specific, the proposed study will evaluate the feasibility of the trial design for an&#xD;
      accessible, non-pharmacological, yoga-based intervention for chronic PCH pain among Veterans&#xD;
      with mTBI, with the long-term goal of informing future efficacy trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headaches per week</measure>
    <time_frame>Change from baseline to approximately 20 weeks</time_frame>
    <description>Headache Tracking Form (HTF) will query about daily headache frequency, duration, severity, and treatment per event.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Post-concussive Headaches</condition>
  <arm_group>
    <arm_group_label>YOGA-NOW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant will start the SAA-TBI (yoga) about 2 weeks (+/- 2 weeks) after Study Visit 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YOGA-WAIT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant will start SAA-TBI (yoga) about 10 weeks (+/- 2 weeks) after Study Visit 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SAA-TBI</intervention_name>
    <description>Yoga twice a week for 75 minutes for 8 weeks</description>
    <arm_group_label>YOGA-NOW</arm_group_label>
    <arm_group_label>YOGA-WAIT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 55&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  History of mTBI per the Ohio State University TBI-ID (OSU-TBI-ID)&#xD;
&#xD;
          -  History of PCH pain (TTH, migraine, or mixed), with onset of pain or increase in&#xD;
             previous headache pain having occurred within one month of mTBI as determined by&#xD;
             structured examination using criteria outlined in the International Classification of&#xD;
             Headache Disorders-3 beta (ICHD-3 beta)&#xD;
&#xD;
          -  Duration of PCH pain being greater than one year as determined by structured medical&#xD;
             examination&#xD;
&#xD;
          -  Score of &gt;49 on the Headache Impact Test-6 (HIT-6)&#xD;
&#xD;
          -  Medical clearance by study provider to participate in yoga protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18, or older than 55 years of age&#xD;
&#xD;
          -  Active substance dependence, excluding Cannabis dependence (based on local issues&#xD;
             regarding the legality of cannabis), as determined by structured clinical interview&#xD;
&#xD;
          -  Moderate to severe TBI as determined per the OSU-TBI-ID&#xD;
&#xD;
          -  Identification of active psychosis as determined by structured clinical interview&#xD;
&#xD;
          -  Failing to receive medical clearance by study provider;&#xD;
&#xD;
          -  Inability to participate in the manualized intervention without postures being&#xD;
             significantly modified&#xD;
&#xD;
          -  Already participating in an ongoing consistent yoga practice (two or more times&#xD;
             weekly)&#xD;
&#xD;
          -  Involvement in another research interventional trial aimed at addressing pain-related&#xD;
             symptoms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa A Brenner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Eastern Colorado Health Care System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rocky Mountain Regional VA Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</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 of Rocky Mountain Mental Illness, Research, Education and Clinical Center</investigator_title>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>Veterans</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Post-concussive Headaches</keyword>
  <keyword>Post-concussive Symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Headache</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/NCT03277859
org study id: 17-0785
nct id: NCT03277859
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The specific aims of the proposed study are to evaluate: 1) the feasibility of design
      elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches
      (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention);
      2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal
      outcomes. Performance of validated measures, including those associated with quality of life,
      as well as data collected via ecological momentary assessment and pedometry (physical
      activity) will be evaluated.
A signature injury being sustained by Veterans from recent conflicts is mild traumatic brain
      injury (mTBI). For some, this condition is associated with multiple disabling post-concussive
      symptoms, including post-concussive headaches (PCH). PCHs are notoriously resistant to
      medication alone, and are associated with increased muscle tension, avoidance of physical
      activities, and anxiety related to having chronic pain. In this study, the feasibility (ease
      of implementation) of the design elements of an interventional trial of Strength and
      Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) will be explored.
      Yoga is operationalized as a practice involving physical postures, breath awareness,
      breathing exercises and mindfulness meditation. It is conceptualized as having three "active
      ingredients" (i.e., regulation of the autonomic nervous system via physical
      activity/breathing exercises, release of muscular tension associated with headaches, and
      mindfulness/acceptance). The specific aims of the proposed study are to evaluate: 1) the
      feasibility of design elements of an SAA-TBI intervention trial (e.g., an exercise run-in to
      facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates
      for candidate proximal and distal outcomes. Performance of validated measures, including
      those associated with quality of life, as well as data collected via ecological momentary
      assessment and pedometry (physical activity) will be evaluated. Project aims will be
      evaluated using an experimental design where participants will be block randomized in a
      stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will
      initially receive 8 weeks of enhanced treatment as usual (ETU). The participants in the
      waitlist condition will be offered SAA-TBI, after the initial group has completed the
      intervention. Both groups of participants will complete multiple measures at baseline and
      after the conclusion of the intervention. Maintenance among the intervention group will also
      be explored. Participants will be asked to complete daily homework documenting their
      headaches and yoga practice outside of class, and be provided with multiple modalities
      (web-based, mobile app, text, or paper and pencil) by which this can be accomplished. In
      specific, the proposed study will evaluate the feasibility of the trial design for an
      accessible, non-pharmacological, yoga-based intervention for chronic PCH pain among Veterans
      with mTBI, with the long-term goal of informing future efficacy trials.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU).
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Headaches per week
time frame: Change from baseline to approximately 20 weeks
description: Headache Tracking Form (HTF) will query about daily headache frequency, duration, severity, and treatment per event.
arm group label: YOGA-NOW
arm group type: Experimental
description: Participant will start the SAA-TBI (yoga) about 2 weeks (+/- 2 weeks) after Study Visit 3.
arm group label: YOGA-WAIT
arm group type: Active Comparator
description: Participant will start SAA-TBI (yoga) about 10 weeks (+/- 2 weeks) after Study Visit 3.
intervention type: Behavioral
intervention name: SAA-TBI
description: Yoga twice a week for 75 minutes for 8 weeks
arm group label: YOGA-NOW
arm group label: YOGA-WAIT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Lisa A Brenner, PhD
role: Principal Investigator
affiliation: VA Eastern Colorado Health Care System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Eastern Colorado Health Care System
investigator full name: Lisa Brenner
investigator title: Director of Rocky Mountain Mental Illness, Research, Education and Clinical Center
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Headache