<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/NCT03816007</url>
  </required_header>
  <id_info>
    <org_study_id>D3009-P</org_study_id>
    <nct_id>NCT03816007</nct_id>
  </id_info>
  <brief_title>Yoga and Mantram for Chronic Pain and PTSD</brief_title>
  <official_title>An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans With PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      PTSD is prevalent among Veterans and is associated with physical and functional impairments&#xD;
      in addition to PTSD symptoms. Veterans with PTSD experience more chronic pain and&#xD;
      pain-related functional limitations than Veterans without PTSD. Mind-body interventions such&#xD;
      as yoga and meditation are non-pharmacological options for treating both chronic pain and&#xD;
      PTSD. This pilot study will add an existing mantram repetition (MR) component designed for&#xD;
      Veterans with PTSD to an active yoga intervention known to improve function in chronic back&#xD;
      pain patients. The study will examine the acceptability of the interventions, adverse events,&#xD;
      and the feasibility of recruitment, attendance, retention, treatment fidelity, and&#xD;
      assessments by recruiting and randomizing 32 VA patients with PTSD to either yoga plus MR or&#xD;
      to a relaxation/health education control. Health outcomes including pain-related function,&#xD;
      pain, and PTSD symptoms will be measured. If feasible, the data will be used to plan a&#xD;
      full-scale trial of enhanced yoga for pain in VA patients with PTSD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of the proposed project are to examine the feasibility of delivering a&#xD;
      combined yoga and MR intervention to VA patients with PTSD and cLBP and/or cNP within a&#xD;
      randomized controlled trial study design. MR enhances the active yoga intervention for this&#xD;
      specific population by providing a portable tool for managing stress and anxiety, and&#xD;
      improving mental and emotional functioning in situations of daily life. The investigators&#xD;
      will recruit and randomize 32 Veterans with PTSD to either enhanced yoga interventions or a&#xD;
      relaxation/health education (R/HE) comparison intervention. The goal of the pilot randomized&#xD;
      trial is to demonstrate the acceptability of the interventions, to study the feasibility of&#xD;
      recruitment, retention, adherence, randomization, and assessments with military Veterans with&#xD;
      PTSD, and to measure any adverse events. Data will inform plans for a full-scale&#xD;
      effectiveness RCT.&#xD;
&#xD;
      Researchers and content experts will adapt and blend two manualized interventions (MR and&#xD;
      yoga) into a single manualized and acceptable intervention. In addition, the existing yoga&#xD;
      intervention and MR manuals will be adapted to provide a structured intervention guide for&#xD;
      instructors. Next, the investigators will recruit and screen 32 Veterans with PTSD. Eligible&#xD;
      participants will be randomized to either the enhanced yoga interventions or the (R/HE)&#xD;
      comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks&#xD;
      after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x&#xD;
      weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home&#xD;
      practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and&#xD;
      will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework&#xD;
      assignments will be included. The investigators will track and measure adverse events,&#xD;
      recruitment rates, attendance and home practice rates, use of MR and yoga principles in daily&#xD;
      life, attrition rates, and time to complete assessments. Questionnaires will assess&#xD;
      pain-related function, pain, PTSD symptoms, insomnia/sleep, alcohol use, and quality of life.&#xD;
      The investigators will also conduct qualitative interviews with 12 study participants to&#xD;
      examine acceptability, recommendations, and factors affecting attendance and attrition. The&#xD;
      investigators will target 7-8 yoga participants and 4-5 control participants. Data will be&#xD;
      used to plan a full-scale RCT powered to detect differences in health outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>
    <intervention_model_description>Eligible participants will be randomized to either the enhanced yoga interventions or the (R/HE) comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework assignments will be included.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are blinded to which intervention is hypothesized to be superior, but are aware of the intervention they are assigned to. All assessments are self-report and do not require interpretation by study investigators.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>Change between baseline and 12-weeks</time_frame>
    <description>The RMDQ has 23 questions asking about limitations experienced with daily activities. The scale is reliable and well validated. It has been used in other yoga studies. Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI)</measure>
    <time_frame>Change between baseline and 12-weeks</time_frame>
    <description>The short version of the Brief Pain Inventory is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Traumatic Stress Disorder Checklist- version 5 (PCL-5)</measure>
    <time_frame>Change between baseline and 12-weeks</time_frame>
    <description>The PCL-5 is a 20-item self-report measure assessing 20 DSM-5 symptoms of PTSD. Each question is rated on a scale from 0-4 and the total score ranges from 0-80 with higher scores indicating a greater severity of PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Change between baseline and 12-weeks</time_frame>
    <description>Insomnia Severity Index is a 7-item instrument that assesses the impact of insomnia. Each question is rated on a scale from 0-4 and the total score ranges from 0-28 with higher scores indicating a greater severity of insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form 36 (SF-36)</measure>
    <time_frame>Change between baseline and 12-weeks</time_frame>
    <description>Health-related Quality of Life will be measured with the SF-36, a descriptive measure providing eight domains of HRQOL. SF-36 norms, reliability and validity are well established. The measure has 8 subscales and 2 summary scales. Each scale score is standardized and thus range from 0-100, with higher scores indicating better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUDIT-C</measure>
    <time_frame>Change between baseline and 12-weeks</time_frame>
    <description>AUDIT-C is a 3-item screen for problem drinking and will refer to alcohol use over the past 3-month period. The measure has questions on typical consumption and binge drinking frequency. Each question is rated on a scale from 0-4 and the total score ranges from 0-12 with higher scores indicating a greater likelihood of alcohol use problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-VA Medications/Treatments</measure>
    <time_frame>12-weeks</time_frame>
    <description>The investigators will assess medications and self-care treatments used outside of VA via a questionnaire. The data are not scored but are added to VA data to provide a Yes/No indication of whether each participant is using pain medications or treatments at the end of intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Post-Traumatic Stress Disorder</condition>
  <condition>Chronic Low Back Pain</condition>
  <condition>Chronic Neck Pain</condition>
  <arm_group>
    <arm_group_label>Yoga and Mantram Repetition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation/Health Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga and Mantram Repetition</intervention_name>
    <description>An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.</description>
    <arm_group_label>Yoga and Mantram Repetition</arm_group_label>
    <other_name>Yoga _+ MR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Veteran Calm</intervention_name>
    <description>A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.</description>
    <arm_group_label>Relaxation/Health Education</arm_group_label>
    <other_name>VC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans Affairs (VA) patients&#xD;
&#xD;
          -  age &gt; 18&#xD;
&#xD;
          -  current diagnosis of PTSD&#xD;
&#xD;
          -  score of 25 on Montreal Cognitive Assessment (MoCA)&#xD;
&#xD;
          -  willing to reduce or cease opioid medications&#xD;
&#xD;
          -  willing to attend 12-weeks of mind-body interventions and complete 3 assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  serious or unstable psychiatric illness&#xD;
&#xD;
               -  e.g. psychosis, mania&#xD;
&#xD;
          -  suicidal or homicidal ideation&#xD;
&#xD;
          -  &lt; 3 months since major trauma event&#xD;
&#xD;
          -  moderate or severe cognitive impairment&#xD;
&#xD;
          -  practiced yoga or mantram repetition &gt; 2x in the last 6 months&#xD;
&#xD;
          -  coexisting medical illness with yoga contraindicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erik J. Groessl, PhD BA BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>chronic pain</keyword>
  <keyword>yoga</keyword>
  <keyword>mantram repetition</keyword>
  <keyword>mind-body interventions</keyword>
  <keyword>complementary and integrative medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Neck Pain</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A de-identified, anonymized dataset will be created and shared. Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the investigator leave the VASDHS the requests may be sent to the VA San Diego Associate Chief of Staff for Research.&#xD;
One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore sufficient to reproduce or verify any published findings. Publications will specify the statistical analytic methods used, thereby enabling recipients to analyze the same data and validate study results.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be made available within 12 months of the end of the study.</ipd_time_frame>
    <ipd_access_criteria>Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the investigator leave the VASDHS the requests may be sent to the VA San Diego Associate Chief of Staff for Research.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03816007/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>December 16, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03816007
org study id: D3009-P
nct id: NCT03816007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
PTSD is prevalent among Veterans and is associated with physical and functional impairments
      in addition to PTSD symptoms. Veterans with PTSD experience more chronic pain and
      pain-related functional limitations than Veterans without PTSD. Mind-body interventions such
      as yoga and meditation are non-pharmacological options for treating both chronic pain and
      PTSD. This pilot study will add an existing mantram repetition (MR) component designed for
      Veterans with PTSD to an active yoga intervention known to improve function in chronic back
      pain patients. The study will examine the acceptability of the interventions, adverse events,
      and the feasibility of recruitment, attendance, retention, treatment fidelity, and
      assessments by recruiting and randomizing 32 VA patients with PTSD to either yoga plus MR or
      to a relaxation/health education control. Health outcomes including pain-related function,
      pain, and PTSD symptoms will be measured. If feasible, the data will be used to plan a
      full-scale trial of enhanced yoga for pain in VA patients with PTSD.
The objectives of the proposed project are to examine the feasibility of delivering a
      combined yoga and MR intervention to VA patients with PTSD and cLBP and/or cNP within a
      randomized controlled trial study design. MR enhances the active yoga intervention for this
      specific population by providing a portable tool for managing stress and anxiety, and
      improving mental and emotional functioning in situations of daily life. The investigators
      will recruit and randomize 32 Veterans with PTSD to either enhanced yoga interventions or a
      relaxation/health education (R/HE) comparison intervention. The goal of the pilot randomized
      trial is to demonstrate the acceptability of the interventions, to study the feasibility of
      recruitment, retention, adherence, randomization, and assessments with military Veterans with
      PTSD, and to measure any adverse events. Data will inform plans for a full-scale
      effectiveness RCT.

      Researchers and content experts will adapt and blend two manualized interventions (MR and
      yoga) into a single manualized and acceptable intervention. In addition, the existing yoga
      intervention and MR manuals will be adapted to provide a structured intervention guide for
      instructors. Next, the investigators will recruit and screen 32 Veterans with PTSD. Eligible
      participants will be randomized to either the enhanced yoga interventions or the (R/HE)
      comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks
      after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x
      weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home
      practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and
      will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework
      assignments will be included. The investigators will track and measure adverse events,
      recruitment rates, attendance and home practice rates, use of MR and yoga principles in daily
      life, attrition rates, and time to complete assessments. Questionnaires will assess
      pain-related function, pain, PTSD symptoms, insomnia/sleep, alcohol use, and quality of life.
      The investigators will also conduct qualitative interviews with 12 study participants to
      examine acceptability, recommendations, and factors affecting attendance and attrition. The
      investigators will target 7-8 yoga participants and 4-5 control participants. Data will be
      used to plan a full-scale RCT powered to detect differences in health outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible participants will be randomized to either the enhanced yoga interventions or the (R/HE) comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework assignments will be included.
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants are blinded to which intervention is hypothesized to be superior, but are aware of the intervention they are assigned to. All assessments are self-report and do not require interpretation by study investigators.
measure: Roland-Morris Disability Questionnaire (RMDQ)
time frame: Change between baseline and 12-weeks
description: The RMDQ has 23 questions asking about limitations experienced with daily activities. The scale is reliable and well validated. It has been used in other yoga studies. Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
measure: Brief Pain Inventory (BPI)
time frame: Change between baseline and 12-weeks
description: The short version of the Brief Pain Inventory is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.
measure: Post-Traumatic Stress Disorder Checklist- version 5 (PCL-5)
time frame: Change between baseline and 12-weeks
description: The PCL-5 is a 20-item self-report measure assessing 20 DSM-5 symptoms of PTSD. Each question is rated on a scale from 0-4 and the total score ranges from 0-80 with higher scores indicating a greater severity of PTSD symptoms.
measure: Insomnia Severity Index (ISI)
time frame: Change between baseline and 12-weeks
description: Insomnia Severity Index is a 7-item instrument that assesses the impact of insomnia. Each question is rated on a scale from 0-4 and the total score ranges from 0-28 with higher scores indicating a greater severity of insomnia.
measure: Short-Form 36 (SF-36)
time frame: Change between baseline and 12-weeks
description: Health-related Quality of Life will be measured with the SF-36, a descriptive measure providing eight domains of HRQOL. SF-36 norms, reliability and validity are well established. The measure has 8 subscales and 2 summary scales. Each scale score is standardized and thus range from 0-100, with higher scores indicating better health-related quality of life.
measure: AUDIT-C
time frame: Change between baseline and 12-weeks
description: AUDIT-C is a 3-item screen for problem drinking and will refer to alcohol use over the past 3-month period. The measure has questions on typical consumption and binge drinking frequency. Each question is rated on a scale from 0-4 and the total score ranges from 0-12 with higher scores indicating a greater likelihood of alcohol use problems.
measure: Non-VA Medications/Treatments
time frame: 12-weeks
description: The investigators will assess medications and self-care treatments used outside of VA via a questionnaire. The data are not scored but are added to VA data to provide a Yes/No indication of whether each participant is using pain medications or treatments at the end of intervention.
arm group label: Yoga and Mantram Repetition
arm group type: Experimental
description: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
arm group label: Relaxation/Health Education
arm group type: Active Comparator
description: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
intervention type: Behavioral
intervention name: Yoga and Mantram Repetition
description: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
arm group label: Yoga and Mantram Repetition
other name: Yoga _+ MR
intervention type: Behavioral
intervention name: Veteran Calm
description: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
arm group label: Relaxation/Health Education
other name: VC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erik J. Groessl, PhD BA BS
role: Principal Investigator
affiliation: VA San Diego Healthcare System, San Diego, CA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Low Back Pain
mesh term: Neck Pain
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Yes
ipd description: A de-identified, anonymized dataset will be created and shared. Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the investigator leave the VASDHS the requests may be sent to the VA San Diego Associate Chief of Staff for Research.
One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore sufficient to reproduce or verify any published findings. Publications will specify the statistical analytic methods used, thereby enabling recipients to analyze the same data and validate study results.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be made available within 12 months of the end of the study.
ipd access criteria: Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the investigator leave the VASDHS the requests may be sent to the VA San Diego Associate Chief of Staff for Research.
provided document: 
submitted: December 16, 2022