<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/NCT01674244</url>
  </required_header>
  <id_info>
    <org_study_id>12-09594</org_study_id>
    <nct_id>NCT01674244</nct_id>
  </id_info>
  <brief_title>Integrative Exercise for Post-Deployment Stress</brief_title>
  <official_title>Integrative Exercise for Post-Deployment Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern California Institute of Research and Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northern California Institute of Research and Education</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the considerable efforts of the DoD and VA to improve awareness of mental health&#xD;
      problems and access to care, many returning veterans still report substantial barriers to&#xD;
      seeking traditional mental health care. Research suggests that a significant barrier to&#xD;
      pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of&#xD;
      this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the&#xD;
      utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise&#xD;
      and mindful breath training) in addressing global post-traumatic stress disorder (PTSD)&#xD;
      symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD.&#xD;
      Specifically, this study will examine whether a 12-week course of Integrative Exercise&#xD;
      therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD&#xD;
      symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves&#xD;
      other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological&#xD;
      distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist&#xD;
      condition) and 3) whether such treatment is feasible and acceptable.&#xD;
&#xD;
      A secondary aim of this study is to evaluate possible mechanisms underlying these effects&#xD;
      such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic&#xD;
      capacity, and improved sleep.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2013</start_date>
  <completion_date type="Actual">August 1, 2015</completion_date>
  <primary_completion_date type="Actual">August 1, 2015</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>Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>PTSD Symptoms</condition>
  <arm_group>
    <arm_group_label>Integrative Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will exercise for 12 weeks (3 times weekly, with each total workout being approximately 60 minutes in length). The exercise protocol will incorporate elements of mindfulness, cardiovascular strengthening, and controlled breathing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monitor Only Waitlist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Monitor Only Waitlist</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrative Exercise</intervention_name>
    <arm_group_label>Integrative Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monitor Only Waitlist</intervention_name>
    <arm_group_label>Monitor Only Waitlist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18-65 and must be physically able to participate in an exercise&#xD;
             program&#xD;
&#xD;
          -  Participants will meet criteria for either current, full syndromal PTSD of at least 3&#xD;
             months duration, as indexed by the Clinician Administered PTSD Scale (CAPS) diagnostic&#xD;
             criteria or partial PTSD defined by meeting the required number of symptoms in the B&#xD;
             symptom cluster as well as the required number of symptoms in either the C or D&#xD;
             symptom clusters.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime history of any psychiatric disorder with psychotic features, bipolar&#xD;
             disorder, or mania or meet criteria for drug or alcohol dependence within the past&#xD;
             year as assessed by the Structured Clinical Interview for DSM-IV-TR.&#xD;
&#xD;
          -  Prominent suicidal or homicidal ideation&#xD;
&#xD;
          -  Currently exposed to recurrent trauma or have been exposed to a traumatic event within&#xD;
             the past 3 months&#xD;
&#xD;
          -  Pregnant, have a clinically significant neurologic disorder, systemic illness&#xD;
             affecting CNS function, history of seizure disorder, asthma, and/or physical&#xD;
             disabilities making it impossible to use exercise equipment will be excluded&#xD;
&#xD;
          -  Myocardial infarction (MI) in the past 6 months&#xD;
&#xD;
          -  Moderate to severe Traumatic Brain Injury (any history of head trauma associated with&#xD;
             the onset of persistent cognitive complaints, neurological symptoms, or loss of&#xD;
             consciousness &gt; 5 minutes)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stress and Health Research Program, University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northern California Institute of Research and Education</investigator_affiliation>
    <investigator_full_name>Thomas C. Neylan, M.D.</investigator_full_name>
    <investigator_title>Professor in Residence</investigator_title>
  </responsible_party>
  <!-- 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/NCT01674244
org study id: 12-09594
nct id: NCT01674244
lead sponsor: 
collaborator: 
has dmc: Yes
Despite the considerable efforts of the DoD and VA to improve awareness of mental health
      problems and access to care, many returning veterans still report substantial barriers to
      seeking traditional mental health care. Research suggests that a significant barrier to
      pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of
      this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the
      utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise
      and mindful breath training) in addressing global post-traumatic stress disorder (PTSD)
      symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD.
      Specifically, this study will examine whether a 12-week course of Integrative Exercise
      therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD
      symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves
      other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological
      distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist
      condition) and 3) whether such treatment is feasible and acceptable.

      A secondary aim of this study is to evaluate possible mechanisms underlying these effects
      such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic
      capacity, and improved sleep.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
time frame: 12 weeks
measure: Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
time frame: 12 weeks
measure: Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
time frame: 12 weeks
arm group label: Integrative Exercise
arm group type: Experimental
description: Subjects will exercise for 12 weeks (3 times weekly, with each total workout being approximately 60 minutes in length). The exercise protocol will incorporate elements of mindfulness, cardiovascular strengthening, and controlled breathing.
arm group label: Monitor Only Waitlist
arm group type: Active Comparator
description: Monitor Only Waitlist
intervention type: Behavioral
intervention name: Integrative Exercise
arm group label: Integrative Exercise
intervention type: Behavioral
intervention name: Monitor Only Waitlist
arm group label: Monitor Only Waitlist
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northern California Institute of Research and Education
investigator full name: Thomas C. Neylan, M.D.
investigator title: Professor in Residence