<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/NCT02224989</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_00052611</org_study_id>
    <nct_id>NCT02224989</nct_id>
  </id_info>
  <brief_title>Mind-Body Intervention for Veterans With PTSD</brief_title>
  <official_title>A Pilot Feasibility Study of a Novel Mind-body Intervention Program for Veterans With PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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>
      This pilot project evaluates the efficacy of a mind-body awareness training intervention,&#xD;
      Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for&#xD;
      relative therapeutic benefit will be indicated by the difference in outcomes from pre- to&#xD;
      post-intervention for PTSD as the primary outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PTSD is a difficult illness to treat and there is a lack of interventions that effectively&#xD;
      reduce it. In recent years, attention has focused on treating PTSD patients by including a&#xD;
      sleep-focused intervention since those with PTSD, such as military personnel, almost always&#xD;
      report some form of sleep disturbance (Neylan et al. 1998; Lewis et al. 2009). In fact, since&#xD;
      sleep disturbance is so prevalent in PTSD, it is considered a hallmark of PTSD diagnosis&#xD;
      (Ross et al. 1989). Two classical PTSD symptoms, hyperarousal and re-experiencing the&#xD;
      traumatic event, comprise sleep difficulty and nightmares, respectively (Lamarche and De&#xD;
      Koninck 2007). Preliminary evidence suggests that interventions targeting sleep may be&#xD;
      beneficial in the treatment of PTSD (Germain et al. 2007; Swanson et al. 2009; Nakamura et&#xD;
      al. 2011).&#xD;
&#xD;
      This study will evaluate the effectiveness of mind-body bridging (MBB) as a primary group&#xD;
      psychotherapy treatment for reduction of PTSD symptoms among veterans. MBB is an awareness&#xD;
      training program,(Block and Block 2007) which has been recently developed into a workbook&#xD;
      specifically for PTSD (Block and Block 2010). MBB has been used successfully at the George E.&#xD;
      Wahlen Veterans Affairs Medical Center (VAMC) for more than 5 years as an adjunctive&#xD;
      treatment. MBB is well accepted by veterans and anecdotally has been reported to improve mood&#xD;
      as well as PTSD and other anxiety symptoms. Furthermore, published pilot studies have&#xD;
      provided preliminary evidence of its benefits.(Tollefson et al. 2009; Nakamura et al. 2011).&#xD;
      In particular, Nakamura et al.(2011) tested a brief sleep-focused MBB intervention program in&#xD;
      a randomized controlled trial, which demonstrated improved sleep and decreased PTSD symptoms.&#xD;
      Our clinical experience and these preliminary studies indicate that a pilot feasibility study&#xD;
      of MBB as a specific treatment for PTSD is warranted.&#xD;
&#xD;
      The proposed, non-randomized single-group study of MBB will serve as a pilot feasibility&#xD;
      study investigating a 10-week MBB program offered to veterans who are clinically diagnosed to&#xD;
      suffer from PTSD. In this pilot study, we determine whether MBB is a beneficial intervention&#xD;
      program for PTSD and co-morbidities, including insomnia, depression, etc., based on&#xD;
      self-report measures and clinical evaluations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    1) Difficulties in recruiting veterans and 2) the funding was used up completely&#xD;
  </why_stopped>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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 the self-report measure of PTSD using the PTSD Checklist for Military (PCLM), from baseline to 3 month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3 month follow-up</time_frame>
    <description>The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on the Diagnostic and Statistical Manual-IV (DSM-IV) criteria, and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of sleep using the Medical Outcomes Study - Sleep Scale (MOS-SS), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>The MOS-SS is a 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The MOS-SS provides an index of sleep problems, including sleep disturbance, sleep adequacy, daytime somnolence, snoring, waking up short of breath with a headache, and quantity of sleep. The MOS-SS was validated as a retrospective assessment of sleep performance over the previous 4 weeks, and compares favorably with the Pittsburgh Sleep Quality Index (PSQI). We have used a modified version of MOS-SS to assess the subject's sleep patterns over the previous 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of resilience using the Response to Stressful Experience Scale (RSES), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>The RSES is a multidimensional measure of resilience validated in a large sample of active-duty and reserve military personnel. This 22-item scale demonstrates good internal consistency. Confirmatory factor analysis revealed reasonable fit for a model of resilience comprising six-dimensions: (1) Cognitive Flexibility, (2) Spirituality, (3) Active Coping, (4) Self-efficacy, (5) Making-meaning, and (6) Restoration. The major strength of this scale is that it is indexed to a specific traumatic or extremely stressful event, such as combat and operational stress in military personnel. .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of Health Related Quality of Life using the Medical Outcomes Study SF-36 for Veterans (VR-36), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>Medical Outcomes Study Short Form-36 (SF-36) for Veterans (VR-36). The VR-36 is a modification of the original SF-36, adapted for Veterans. It consists of the same eight sections as the SF-36. The instrument provides a global score, as well as the following subscale scores: functional capacity, physical aspects, pain, general health condition, vitality, social aspects and emotional aspects, and mental health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of depression using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>The CES-D is one of the most common validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of mindfulness using the Five-facet Mindfulness Questionnaire (FFMQ), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>The FFMQ includes 39 items and assesses five distinct, interpretable facets of mindfulness, including: 1) observing, 2) describing, 3) acting with awareness, 4) non-judging of inner experience, and 5) non-reactivity to inner experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of well-being using the Well-Being Index (WBI), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>The WBI is a five item scale evaluating both positive and negative aspects of emotional functioning, developed and validated by the World Health Organization Collaborating Centre in Mental Health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of health-related quality of life using the Medical Outcomes Study Short Form - 12 (SF-12), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>The SF-12 is a much shortened version of the SF-36, comprising 12 items. It will be measured on a weekly basis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subjective measure of quality of life using the Mind-Body Bridging Quality of Life scale (MBB QOL), from baseline to 3-month follow-up.</measure>
    <time_frame>Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up</time_frame>
    <description>The MBB QOL is a non-validated questionnaire used to assess the effects of MBB on quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <arm_group>
    <arm_group_label>Mind-Body Bridging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An awareness training program using mindfulness-based techniques.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mind-Body Bridging</intervention_name>
    <description>An awareness training program. One 2 hr class per week for 10 weeks.</description>
    <arm_group_label>Mind-Body Bridging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion of subjects will be based on: pre-screening score of 50 or greater on the&#xD;
             PTSD Checklist for Military (PCL-M). Since we are also interested in the effects of&#xD;
             MBB on co-morbid illnesses besides PTSD, we will include subjects who present with&#xD;
             other behavioral health conditions, including sleep disturbance, depression, anxiety,&#xD;
             pain, and any general medical conditions, except as defined as exclusion criteria.&#xD;
             Subjects using anti-anxiety, anti-depressants, sleep and pain medications, and other&#xD;
             medications for any condition that is not under exclusion criteria will be admitted to&#xD;
             the study. Participants must be willing to commit to the 10-week course and complete&#xD;
             all outcome measures, be literate in English and able to provide informed consent.&#xD;
&#xD;
        Participants will be asked to refrain from engaging in other PTSD treatment programs for&#xD;
        the duration of the proposed study, but can remain on their medications and continue with&#xD;
        their usual medical or mental health care. They will also be allowed to continue with other&#xD;
        activities (such as physical exercise, meditation, yoga, etc.), which they may have already&#xD;
        incorporated into their life.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A patient will be excluded from the study under the following conditions:&#xD;
&#xD;
               1. currently enrolled in active PTSD treatment program.&#xD;
&#xD;
               2. identifying with major psychopathology (i.e., schizophrenia, mania, or poorly&#xD;
                  controlled bipolar disorder, borderline or antisocial personality disorder) and&#xD;
                  was psychiatrically hospitalized within the past 90 days.&#xD;
&#xD;
               3. cognitive impairment or dementia.&#xD;
&#xD;
               4. severe medical disease such as uncontrolled hypertension or diabetes, or terminal&#xD;
                  illness, e.g., cancer.&#xD;
&#xD;
               5. active substance abuse disorder&#xD;
&#xD;
               6. suicidal ideation with intent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoshio Nakamura, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salt Lake City Veterans Affairs Health Care System</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Yoshio Nakamura</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </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>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/NCT02224989
org study id: IRB_00052611
nct id: NCT02224989
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot project evaluates the efficacy of a mind-body awareness training intervention,
      Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for
      relative therapeutic benefit will be indicated by the difference in outcomes from pre- to
      post-intervention for PTSD as the primary outcome.
PTSD is a difficult illness to treat and there is a lack of interventions that effectively
      reduce it. In recent years, attention has focused on treating PTSD patients by including a
      sleep-focused intervention since those with PTSD, such as military personnel, almost always
      report some form of sleep disturbance (Neylan et al. 1998; Lewis et al. 2009). In fact, since
      sleep disturbance is so prevalent in PTSD, it is considered a hallmark of PTSD diagnosis
      (Ross et al. 1989). Two classical PTSD symptoms, hyperarousal and re-experiencing the
      traumatic event, comprise sleep difficulty and nightmares, respectively (Lamarche and De
      Koninck 2007). Preliminary evidence suggests that interventions targeting sleep may be
      beneficial in the treatment of PTSD (Germain et al. 2007; Swanson et al. 2009; Nakamura et
      al. 2011).

      This study will evaluate the effectiveness of mind-body bridging (MBB) as a primary group
      psychotherapy treatment for reduction of PTSD symptoms among veterans. MBB is an awareness
      training program,(Block and Block 2007) which has been recently developed into a workbook
      specifically for PTSD (Block and Block 2010). MBB has been used successfully at the George E.
      Wahlen Veterans Affairs Medical Center (VAMC) for more than 5 years as an adjunctive
      treatment. MBB is well accepted by veterans and anecdotally has been reported to improve mood
      as well as PTSD and other anxiety symptoms. Furthermore, published pilot studies have
      provided preliminary evidence of its benefits.(Tollefson et al. 2009; Nakamura et al. 2011).
      In particular, Nakamura et al.(2011) tested a brief sleep-focused MBB intervention program in
      a randomized controlled trial, which demonstrated improved sleep and decreased PTSD symptoms.
      Our clinical experience and these preliminary studies indicate that a pilot feasibility study
      of MBB as a specific treatment for PTSD is warranted.

      The proposed, non-randomized single-group study of MBB will serve as a pilot feasibility
      study investigating a 10-week MBB program offered to veterans who are clinically diagnosed to
      suffer from PTSD. In this pilot study, we determine whether MBB is a beneficial intervention
      program for PTSD and co-morbidities, including insomnia, depression, etc., based on
      self-report measures and clinical evaluations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the self-report measure of PTSD using the PTSD Checklist for Military (PCLM), from baseline to 3 month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3 month follow-up
description: The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on the Diagnostic and Statistical Manual-IV (DSM-IV) criteria, and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.
measure: Change in subjective measure of sleep using the Medical Outcomes Study - Sleep Scale (MOS-SS), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: The MOS-SS is a 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The MOS-SS provides an index of sleep problems, including sleep disturbance, sleep adequacy, daytime somnolence, snoring, waking up short of breath with a headache, and quantity of sleep. The MOS-SS was validated as a retrospective assessment of sleep performance over the previous 4 weeks, and compares favorably with the Pittsburgh Sleep Quality Index (PSQI). We have used a modified version of MOS-SS to assess the subject's sleep patterns over the previous 7 days.
measure: Change in subjective measure of resilience using the Response to Stressful Experience Scale (RSES), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: The RSES is a multidimensional measure of resilience validated in a large sample of active-duty and reserve military personnel. This 22-item scale demonstrates good internal consistency. Confirmatory factor analysis revealed reasonable fit for a model of resilience comprising six-dimensions: (1) Cognitive Flexibility, (2) Spirituality, (3) Active Coping, (4) Self-efficacy, (5) Making-meaning, and (6) Restoration. The major strength of this scale is that it is indexed to a specific traumatic or extremely stressful event, such as combat and operational stress in military personnel. .
measure: Change in subjective measure of Health Related Quality of Life using the Medical Outcomes Study SF-36 for Veterans (VR-36), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: Medical Outcomes Study Short Form-36 (SF-36) for Veterans (VR-36). The VR-36 is a modification of the original SF-36, adapted for Veterans. It consists of the same eight sections as the SF-36. The instrument provides a global score, as well as the following subscale scores: functional capacity, physical aspects, pain, general health condition, vitality, social aspects and emotional aspects, and mental health.
measure: Change in subjective measure of depression using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: The CES-D is one of the most common validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week.
measure: Change in subjective measure of mindfulness using the Five-facet Mindfulness Questionnaire (FFMQ), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: The FFMQ includes 39 items and assesses five distinct, interpretable facets of mindfulness, including: 1) observing, 2) describing, 3) acting with awareness, 4) non-judging of inner experience, and 5) non-reactivity to inner experience.
measure: Change in subjective measure of well-being using the Well-Being Index (WBI), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: The WBI is a five item scale evaluating both positive and negative aspects of emotional functioning, developed and validated by the World Health Organization Collaborating Centre in Mental Health.
measure: Change in subjective measure of health-related quality of life using the Medical Outcomes Study Short Form - 12 (SF-12), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: The SF-12 is a much shortened version of the SF-36, comprising 12 items. It will be measured on a weekly basis.
measure: Change in subjective measure of quality of life using the Mind-Body Bridging Quality of Life scale (MBB QOL), from baseline to 3-month follow-up.
time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
description: The MBB QOL is a non-validated questionnaire used to assess the effects of MBB on quality of life.
arm group label: Mind-Body Bridging
arm group type: Experimental
description: An awareness training program using mindfulness-based techniques.
intervention type: Behavioral
intervention name: Mind-Body Bridging
description: An awareness training program. One 2 hr class per week for 10 weeks.
arm group label: Mind-Body Bridging
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yoshio Nakamura, Ph.D.
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Yoshio Nakamura
investigator title: Research Associate Professor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No