<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/NCT03302312</url>
  </required_header>
  <id_info>
    <org_study_id>SGB-201a</org_study_id>
    <nct_id>NCT03302312</nct_id>
  </id_info>
  <brief_title>Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Acceptability</brief_title>
  <official_title>A Randomized, Sham-procedure-controlled, Blinded Study to Evaluate the Effectiveness and Acceptability of Right-sided Stellate Ganglion Block for Treatment of Posttraumatic Stress Disorder Symptoms - Acceptability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Womack Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tripler Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Landstuhl Regional Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>RTI International</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This qualitative study will use focus groups, small group interviews, and individual&#xD;
      interviews (both in person and over the phone) to compile a range of perspectives on service&#xD;
      members' decision-making processes and information needs related to Stellate Ganglion Block&#xD;
      (SGB). Participants will include service members, spouses, and providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The qualitative (acceptability) study will use focus groups, small group interviews, and&#xD;
      individual interviews (both in person and telephonic) to compile a range of perspectives on&#xD;
      service members' decision-making processes and information needs related to SGB. Participants&#xD;
      will include service members, spouses, and providers. Data collection will occur at each&#xD;
      study site because attitudes conveyed by leadership and chain of command may vary across&#xD;
      installation. Scheduling will be based on the accumulation of ample service members&#xD;
      indicating an interest in participating.&#xD;
&#xD;
      All service members enrolled in the clinical effectiveness trial (Study Number: NCT03077919)&#xD;
      will be eligible for the qualitative study if they have received at least one SGB study&#xD;
      procedure during the three months prior to qualitative data collection. When qualitative data&#xD;
      collection is scheduled, the study team will approach service members who indicated initial&#xD;
      interest in participating in the acceptability if they still meet the eligibility criteria.&#xD;
      Service members will not be contacted for qualitative study participation if the Research&#xD;
      Coordinator or treating provider considers that participation would cause undue distress&#xD;
      based on their most recent contact with the individual.&#xD;
&#xD;
      Service members who did not participate in the clinical effectiveness trial are eligible for&#xD;
      the qualitative study if they have received at least one SGB for PTSD symptoms at a study&#xD;
      site in the three months prior to qualitative data collection and if participation would not&#xD;
      cause undue distress. These participants will be recruited in the clinic as well as through a&#xD;
      medical record search conducted by the Site PI or other clinical staff.&#xD;
&#xD;
      Assignment to specific focus groups will be based on pay grade and subjective assessment of&#xD;
      change as reported at the 4-Week assessment or at the time of screening for the qualitative&#xD;
      study. In order to maximize homogeneity, lower enlisted service members and non-commissioned&#xD;
      officers (NCOs) will be assigned to different groups. These groups will be further divided so&#xD;
      that those reporting positive change since the procedure will be assigned to a different&#xD;
      group than those reporting no change or feeling worse than at the time of the procedure.&#xD;
      Depending on the number of eligible participants by pay grade, officers may be interviewed&#xD;
      individually.&#xD;
&#xD;
      Eligible service members, both clinical trial and non-clinical trial participants, may be&#xD;
      assigned to a service member/spouse dyad subgroup if they meet the above criteria and their&#xD;
      spouse has expressed an interest in participating in the qualitative study. Those service&#xD;
      members who participate as part of the dyad subgroup will not be eligible to participate in&#xD;
      the service member only focus groups.&#xD;
&#xD;
      Eligible participants for the provider focus groups will be Behavioral Health or other (e.g.,&#xD;
      Family Medicine) clinicians who have referred or could potentially refer service members for&#xD;
      SGB for PTSD symptoms, as well as physicians who provide SGBs.&#xD;
&#xD;
      The planned focus group interviews will be structured discussions on a particular topic&#xD;
      involving a small number of people under the direction of a moderator (Krueger &amp; Casey,&#xD;
      2000). The method relies on both the interactive social context of the discussion and on the&#xD;
      individual experiences of each of the group members to produce a rich discussion in which&#xD;
      shared experiences stimulate individual contributions.&#xD;
&#xD;
      The qualitative study will explore participants' perceptions of SGB in relation to other&#xD;
      options for treatment of PTSD, from the perspectives of service members, service&#xD;
      member/spouse couples, and providers. Broad topics covered in service member focus groups,&#xD;
      service members/spouse interviews, and provider focus group are:&#xD;
&#xD;
        -  Context for mental health and treatment&#xD;
&#xD;
        -  Advantages and drawbacks of treatment options&#xD;
&#xD;
        -  Information and decision-making&#xD;
&#xD;
        -  Experience and expectations&#xD;
&#xD;
      Focus groups and small group interviews will take approximately 90 minutes, service&#xD;
      member-significant other interviews will take approximately 60 minutes, and individual&#xD;
      interviews will take approximately 45 minutes.&#xD;
&#xD;
      All focus groups and interviews will be led by a study team member with prior experience in&#xD;
      qualitative data collection with clinicians and service members engaged in mental health&#xD;
      treatment. Real-time notes will be collected by a second team member but each focus group or&#xD;
      interview will also be audio-recorded if all participants give permission to do so. The&#xD;
      purpose of the audio recordings is to augment any notes taken by the second team member.&#xD;
&#xD;
      Data from focus groups and interviews will be summarized in topline notes as soon as feasible&#xD;
      after data collection. In-depth analysis will employ standard qualitative methods. All notes&#xD;
      will be entered into qualitative data base software such as NVivo 9 (QSR International Pty&#xD;
      Ltd. Version 9, 2010) to facilitate coding and retrieval. Analysis will be both deductive,&#xD;
      following a hierarchical coding structure based on topic guide questions, and inductive,&#xD;
      creating queries to assess patterns observed in the data and hypotheses emerging from&#xD;
      preliminary analyses. Analytical matrixes to compare responses across respondent types will&#xD;
      also be constructed. Comparisons of interest include enlisted, NCO, officer; service member,&#xD;
      spouse; service member, provider; self-assessed improvement, no self-assessed improvement;&#xD;
      Behavioral Health clinicians, Family Medicine physicians; and study sites&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2017</start_date>
  <completion_date type="Actual">March 2, 2018</completion_date>
  <primary_completion_date type="Actual">March 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of service members or service member/spouse couples.</measure>
    <time_frame>Within three month of receiving one SGB study procedure for PTSD symptoms</time_frame>
    <description>Discussion topic areas:&#xD;
Context for mental health and treatment&#xD;
Advantages and drawbacks of treatment options&#xD;
Information and decision-making&#xD;
Experience and expectations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of providers</measure>
    <time_frame>Through study completion, approximately six months</time_frame>
    <description>Discussion topic areas:&#xD;
Context for mental health and treatment&#xD;
Advantages and drawbacks of treatment options&#xD;
Information and decision-making&#xD;
Experience and expectations</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <description>Service members who received at least one SGB study procedure as part of the clinical effectiveness trial during the three months prior to qualitative data collection or service members who received at least one SGB for PTSD symptoms at a study site in the three months prior to qualitative data collection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Providers</arm_group_label>
    <description>Behavioral Health or other (e.g., Family Medicine) clinicians who have referred or could potentially have referred service members for SGB for PTSD symptoms, as well as physicians who provide SGBs.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        -  participants in effectiveness clinical trial and their spouses&#xD;
&#xD;
          -  service members who have received SGB for PTSD symptoms at the participating study&#xD;
             sites outside of the clinical trial and their spouse&#xD;
&#xD;
          -  providers who have referred or could potentially have referred patients for SGB for&#xD;
             PTSD symptoms at the study sites&#xD;
&#xD;
          -  clinicians who provide SGB for PTSD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Service members must have received at least one SGB and/or study procedure for PTSD&#xD;
             symptoms during the past three months at a participating study site (as a participant&#xD;
             in the clinical effectiveness trial or outside of the study).&#xD;
&#xD;
          -  Clinical trial participants must have indicated willingness to participate in the&#xD;
             qualitative study when asked by the Research Coordinator (RC) at baseline data&#xD;
             collection.&#xD;
&#xD;
          -  Non-clinical trial participants must be active-duty status.&#xD;
&#xD;
          -  A service member/spouse dyad will consist of a service member meeting an above&#xD;
             criterion and his/her spouse.&#xD;
&#xD;
          -  Providers will be Behavioral Health or other (e.g., Family Medicine) clinicians who&#xD;
             have referred or could potentially have referred service members to the study, and&#xD;
             physicians who administer SGBs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Service members will be excluded from the qualitative study if participation would cause&#xD;
        them undue distress, in the opinion of the RC or treating clinician.&#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>Bradford B Walters, MD, PhD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTI International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tripler Army Medical Center (TAMC)</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96859</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womack Army Medical Center (WAMC)</name>
      <address>
        <city>Fort Bragg</city>
        <state>North Carolina</state>
        <zip>28310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landstuhl Regional Medical Center (LRMC)</name>
      <address>
        <city>Landstuhl</city>
        <zip>66849</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Krueger, R.A., &amp; M.A. Casey, M. A. (2000). Focus groups. A practical guide for applied research. Thousand Oaks, CA: Sage.</citation>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>Generalized Anxiety Disorder</keyword>
  <keyword>Depression</keyword>
  <keyword>Distress</keyword>
  <keyword>Alcohol Use</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <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/NCT03302312
org study id: SGB-201a
nct id: NCT03302312
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This qualitative study will use focus groups, small group interviews, and individual
      interviews (both in person and over the phone) to compile a range of perspectives on service
      members' decision-making processes and information needs related to Stellate Ganglion Block
      (SGB). Participants will include service members, spouses, and providers.
The qualitative (acceptability) study will use focus groups, small group interviews, and
      individual interviews (both in person and telephonic) to compile a range of perspectives on
      service members' decision-making processes and information needs related to SGB. Participants
      will include service members, spouses, and providers. Data collection will occur at each
      study site because attitudes conveyed by leadership and chain of command may vary across
      installation. Scheduling will be based on the accumulation of ample service members
      indicating an interest in participating.

      All service members enrolled in the clinical effectiveness trial (Study Number: NCT03077919)
      will be eligible for the qualitative study if they have received at least one SGB study
      procedure during the three months prior to qualitative data collection. When qualitative data
      collection is scheduled, the study team will approach service members who indicated initial
      interest in participating in the acceptability if they still meet the eligibility criteria.
      Service members will not be contacted for qualitative study participation if the Research
      Coordinator or treating provider considers that participation would cause undue distress
      based on their most recent contact with the individual.

      Service members who did not participate in the clinical effectiveness trial are eligible for
      the qualitative study if they have received at least one SGB for PTSD symptoms at a study
      site in the three months prior to qualitative data collection and if participation would not
      cause undue distress. These participants will be recruited in the clinic as well as through a
      medical record search conducted by the Site PI or other clinical staff.

      Assignment to specific focus groups will be based on pay grade and subjective assessment of
      change as reported at the 4-Week assessment or at the time of screening for the qualitative
      study. In order to maximize homogeneity, lower enlisted service members and non-commissioned
      officers (NCOs) will be assigned to different groups. These groups will be further divided so
      that those reporting positive change since the procedure will be assigned to a different
      group than those reporting no change or feeling worse than at the time of the procedure.
      Depending on the number of eligible participants by pay grade, officers may be interviewed
      individually.

      Eligible service members, both clinical trial and non-clinical trial participants, may be
      assigned to a service member/spouse dyad subgroup if they meet the above criteria and their
      spouse has expressed an interest in participating in the qualitative study. Those service
      members who participate as part of the dyad subgroup will not be eligible to participate in
      the service member only focus groups.

      Eligible participants for the provider focus groups will be Behavioral Health or other (e.g.,
      Family Medicine) clinicians who have referred or could potentially refer service members for
      SGB for PTSD symptoms, as well as physicians who provide SGBs.

      The planned focus group interviews will be structured discussions on a particular topic
      involving a small number of people under the direction of a moderator (Krueger & Casey,
      2000). The method relies on both the interactive social context of the discussion and on the
      individual experiences of each of the group members to produce a rich discussion in which
      shared experiences stimulate individual contributions.

      The qualitative study will explore participants' perceptions of SGB in relation to other
      options for treatment of PTSD, from the perspectives of service members, service
      member/spouse couples, and providers. Broad topics covered in service member focus groups,
      service members/spouse interviews, and provider focus group are:

        -  Context for mental health and treatment

        -  Advantages and drawbacks of treatment options

        -  Information and decision-making

        -  Experience and expectations

      Focus groups and small group interviews will take approximately 90 minutes, service
      member-significant other interviews will take approximately 60 minutes, and individual
      interviews will take approximately 45 minutes.

      All focus groups and interviews will be led by a study team member with prior experience in
      qualitative data collection with clinicians and service members engaged in mental health
      treatment. Real-time notes will be collected by a second team member but each focus group or
      interview will also be audio-recorded if all participants give permission to do so. The
      purpose of the audio recordings is to augment any notes taken by the second team member.

      Data from focus groups and interviews will be summarized in topline notes as soon as feasible
      after data collection. In-depth analysis will employ standard qualitative methods. All notes
      will be entered into qualitative data base software such as NVivo 9 (QSR International Pty
      Ltd. Version 9, 2010) to facilitate coding and retrieval. Analysis will be both deductive,
      following a hierarchical coding structure based on topic guide questions, and inductive,
      creating queries to assess patterns observed in the data and hypotheses emerging from
      preliminary analyses. Analytical matrixes to compare responses across respondent types will
      also be constructed. Comparisons of interest include enlisted, NCO, officer; service member,
      spouse; service member, provider; self-assessed improvement, no self-assessed improvement;
      Behavioral Health clinicians, Family Medicine physicians; and study sites
observational model: Other
time perspective: Retrospective
measure: Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of service members or service member/spouse couples.
time frame: Within three month of receiving one SGB study procedure for PTSD symptoms
description: Discussion topic areas:
Context for mental health and treatment
Advantages and drawbacks of treatment options
Information and decision-making
Experience and expectations
measure: Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of providers
time frame: Through study completion, approximately six months
description: Discussion topic areas:
Context for mental health and treatment
Advantages and drawbacks of treatment options
Information and decision-making
Experience and expectations
arm group label: Participants
description: Service members who received at least one SGB study procedure as part of the clinical effectiveness trial during the three months prior to qualitative data collection or service members who received at least one SGB for PTSD symptoms at a study site in the three months prior to qualitative data collection.
arm group label: Providers
description: Behavioral Health or other (e.g., Family Medicine) clinicians who have referred or could potentially have referred service members for SGB for PTSD symptoms, as well as physicians who provide SGBs.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bradford B Walters, MD, PhD, MBA
role: Principal Investigator
affiliation: RTI International
facility: 
facility: 
facility: 
country: Germany
country: United States
citation: Krueger, R.A., & M.A. Casey, M. A. (2000). Focus groups. A practical guide for applied research. Thousand Oaks, CA: Sage.
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No