<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/NCT01725854</url>
  </required_header>
  <id_info>
    <org_study_id>W81XWH-10-1-1011/ 367294</org_study_id>
    <nct_id>NCT01725854</nct_id>
  </id_info>
  <brief_title>Relaxation Response Training for PTSD Prevention in US Military Personnel</brief_title>
  <acronym>RR</acronym>
  <official_title>Relaxation Response (RR) Training for PTSD Prevention in Soldiers a.k.a. &quot;SPIRIT SMART&quot; (Stemming PTSD, Increasing Resilience and Impeding Trauma in Service Members: Assessing Relaxation Response Training)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Army Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study are to evaluate the acceptability and utility of a mind-body&#xD;
      intervention on a convenience sample of Soldiers (n=120) who have screened positive through&#xD;
      RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness&#xD;
      of this Relaxation Response (RR) intervention designed to decrease the physiological and&#xD;
      psychosocial effects of stress and trauma. The study aims to enhance the psychological health&#xD;
      of Soldiers with a RR intervention designed to promote self-awareness of physiological&#xD;
      responses to stress and the ability to increase relaxation responses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aims:&#xD;
&#xD;
        1. Demonstrate that trainers can be trained effectively to deliver the intervention, a&#xD;
           mind-body skills training program based on the Benson-Henry Institute's standard RR&#xD;
           training curriculum and tailored to a military population.&#xD;
&#xD;
        2. Evaluate feasibility, acceptability, and compliance to the training program in an active&#xD;
           duty military population.&#xD;
&#xD;
        3. Compare outcomes on sleep disturbance, PTSD, stress-related symptoms, quality of life,&#xD;
           and psychosocial variables related to resilience of Soldiers who receive the 6-week&#xD;
           training program to promote the Relaxation Response to those Soldiers who do not receive&#xD;
           the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Loss of staff for completion&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sleep will be measured pre and post intervention. Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality and disturbances during the past month based on seven component scores for sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction that sum to a global score. A Sleep Diary will also be used to measure sleep and related factors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anger</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Health Status as measured with the Veterans RAND 12-item Health Survey Short Form (VR-12 or SF-12) and the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 (Non-Illness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Resilience will be measured with the Post Traumatic Growth Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Relaxation Response Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Military tailored RR training program will consist of six weekly small group sessions which involve group presentations, in-group skill building exercises, and at-home assignments. Groups will contain 5-8 participants who are active-duty Soldiers enrolled in either Respect-MIL or the Interdisciplinary Pain Management Center (IPMC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the control group will receive standard care through their providers at Respect-MIL or at the IPMC. Participants randomized to the control group will remain on the wait list for further standard care. After the collection of the final data point, these participants will also have the option to participate in an abbreviated, two-hour version of the RR training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation Response training</intervention_name>
    <description>Behavioral Relaxation Response Training (Benson-Henry Institute Relaxation Response Training) Participants randomized to the intervention group will participate in the six weekly RR sessions. Examples of in-group skill building exercises are mini relaxations, diaphragmatic breathing, introduction to imagery, and eliciting RR through Yoga. Presentations topics include Introduction to Mind/Body Medicine, Introduction to the RR, Experiential RR Sessions, and Introduction to Cognitive Restructuring. Home skill building assignments include relaxation focus practice, an appreciation journal, self-monitoring with Biodots (biosensor technology that helps participants to monitor and regulate their psycho-emotional state), physical activity, balanced nutrition, and progress notes.</description>
    <arm_group_label>Relaxation Response Training</arm_group_label>
    <other_name>Benson-Henry Institute Relaxation response training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older, male and female volunteer individual military Service Members, DoD&#xD;
             civilians or approved contractors working for DoD, primarily from multidisciplinary&#xD;
             healthcare providers.&#xD;
&#xD;
          -  Willingness to participate in the research project.&#xD;
&#xD;
          -  Committed to the entire period of time of the research project.&#xD;
&#xD;
          -  Currently working or stationed at Ft Bliss, Texas.&#xD;
&#xD;
          -  No impending orders for deployment/ TDY/ PCS/ ETS or retirement for at least 8 weeks&#xD;
             from the day of study enrollment.&#xD;
&#xD;
          -  Able to read and speak English.&#xD;
&#xD;
          -  Capable to consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Diagnosed with severe PTSD or other mental health issues disclosed as self-reported&#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>Richard P Petri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Army Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Beaumont Army Medical Center, Ft Bliss</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>October 31, 2016</last_update_submitted>
  <last_update_submitted_qc>October 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Study terminated</ipd_description>
  </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/NCT01725854
org study id: W81XWH-10-1-1011/ 367294
nct id: NCT01725854
lead sponsor: 
has dmc: Yes
The purposes of this study are to evaluate the acceptability and utility of a mind-body
      intervention on a convenience sample of Soldiers (n=120) who have screened positive through
      RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness
      of this Relaxation Response (RR) intervention designed to decrease the physiological and
      psychosocial effects of stress and trauma. The study aims to enhance the psychological health
      of Soldiers with a RR intervention designed to promote self-awareness of physiological
      responses to stress and the ability to increase relaxation responses.
Specific Aims:

        1. Demonstrate that trainers can be trained effectively to deliver the intervention, a
           mind-body skills training program based on the Benson-Henry Institute's standard RR
           training curriculum and tailored to a military population.

        2. Evaluate feasibility, acceptability, and compliance to the training program in an active
           duty military population.

        3. Compare outcomes on sleep disturbance, PTSD, stress-related symptoms, quality of life,
           and psychosocial variables related to resilience of Soldiers who receive the 6-week
           training program to promote the Relaxation Response to those Soldiers who do not receive
           the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Sleep
time frame: 6 weeks
description: Sleep will be measured pre and post intervention. Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality and disturbances during the past month based on seven component scores for sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction that sum to a global score. A Sleep Diary will also be used to measure sleep and related factors.
measure: Anger
time frame: 6 Weeks
description: Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)
measure: Health Status
time frame: 6 Weeks
description: Health Status as measured with the Veterans RAND 12-item Health Survey Short Form (VR-12 or SF-12) and the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 (Non-Illness)
measure: Resilience
time frame: 6 Weeks
description: Resilience will be measured with the Post Traumatic Growth Inventory
measure: Stress
time frame: 6 Weeks
description: Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale
arm group label: Relaxation Response Training
arm group type: Experimental
description: The Military tailored RR training program will consist of six weekly small group sessions which involve group presentations, in-group skill building exercises, and at-home assignments. Groups will contain 5-8 participants who are active-duty Soldiers enrolled in either Respect-MIL or the Interdisciplinary Pain Management Center (IPMC).
arm group label: Standard of Care
arm group type: No Intervention
description: Participants randomized to the control group will receive standard care through their providers at Respect-MIL or at the IPMC. Participants randomized to the control group will remain on the wait list for further standard care. After the collection of the final data point, these participants will also have the option to participate in an abbreviated, two-hour version of the RR training.
intervention type: Behavioral
intervention name: Relaxation Response training
description: Behavioral Relaxation Response Training (Benson-Henry Institute Relaxation Response Training) Participants randomized to the intervention group will participate in the six weekly RR sessions. Examples of in-group skill building exercises are mini relaxations, diaphragmatic breathing, introduction to imagery, and eliciting RR through Yoga. Presentations topics include Introduction to Mind/Body Medicine, Introduction to the RR, Experiential RR Sessions, and Introduction to Cognitive Restructuring. Home skill building assignments include relaxation focus practice, an appreciation journal, self-monitoring with Biodots (biosensor technology that helps participants to monitor and regulate their psycho-emotional state), physical activity, balanced nutrition, and progress notes.
arm group label: Relaxation Response Training
other name: Benson-Henry Institute Relaxation response training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Richard P Petri, MD
role: Principal Investigator
affiliation: William Beaumont Army Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Undecided
ipd description: Study terminated