<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/NCT03271411</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1002</org_study_id>
    <nct_id>NCT03271411</nct_id>
  </id_info>
  <brief_title>Extension of EMDR vs. PC For Motor Vehicle Accident Trauma</brief_title>
  <official_title>Extension of EMDR vs. PC For Motor Vehicle Accident Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trauma Institute &amp; Child Trauma Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Trauma Institute &amp; Child Trauma Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an extension of a randomized clinical trial comparing eye movement desensitization&#xD;
      and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who&#xD;
      are distressed by the memory of a motor vehicle accident. The purpose of this extension is to&#xD;
      add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to&#xD;
      see a) if that has any impact on participant retention, treatment effectiveness, or treatment&#xD;
      efficiency; and b) if such impact is equivalent with EMDR and PC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SUDS following treatment</measure>
    <time_frame>Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment</time_frame>
    <description>Subjective Units of Distress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PRS following treatment</measure>
    <time_frame>Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment</time_frame>
    <description>Problem Rating Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PDS following treatment</measure>
    <time_frame>Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment</time_frame>
    <description>PTSD Diagnostic Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Trauma, Psychological</condition>
  <condition>Motor Vehicle Accident</condition>
  <arm_group>
    <arm_group_label>Eye movement desensitization and reprocessing (EMDR) arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Progressive counting (PC) arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EMDR-based Flash technique</intervention_name>
    <description>Initial EMDR session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour</description>
    <arm_group_label>Eye movement desensitization and reprocessing (EMDR) arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PC-based Flash technique</intervention_name>
    <description>Initial PC session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour</description>
    <arm_group_label>Progressive counting (PC) arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult reporting distress related to motor vehicle accident-related trauma&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  already in therapy in which the memory of interest is being actively addressed with a&#xD;
             structured/focused trauma resolution method&#xD;
&#xD;
          -  any obvious/urgent need for more comprehensive psychotherapy (based on initial&#xD;
             screening interview)&#xD;
&#xD;
          -  any indication of instability during interactions prior to the therapy session&#xD;
&#xD;
          -  an average score on the Dissociative Experiences Scale of 30 or greater, if (as per&#xD;
             follow-up questions) indicating a likely dissociative disorder&#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>Ricky Greenwald, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Trauma Institute &amp; Child Trauma Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ricky Greenwald, PsyD</last_name>
    <phone>413-774-2340</phone>
    <email>cti@childtrauma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Trauma Institute &amp; Child Trauma Institute</name>
      <address>
        <city>Northampton</city>
        <state>Massachusetts</state>
        <zip>01060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ricky Greenwald, PsyD</last_name>
      <phone>413-774-2340</phone>
      <email>cti@childtrauma.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</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>Wounds and Injuries</mesh_term>
    <mesh_term>Psychological Trauma</mesh_term>
  </condition_browse>
  <!-- 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/NCT03271411
org study id: 2017-1002
nct id: NCT03271411
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is an extension of a randomized clinical trial comparing eye movement desensitization
      and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who
      are distressed by the memory of a motor vehicle accident. The purpose of this extension is to
      add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to
      see a) if that has any impact on participant retention, treatment effectiveness, or treatment
      efficiency; and b) if such impact is equivalent with EMDR and PC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in SUDS following treatment
time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
description: Subjective Units of Distress Scale
measure: Change in PRS following treatment
time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
description: Problem Rating Scale
measure: Change in PDS following treatment
time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
description: PTSD Diagnostic Scale
arm group label: Eye movement desensitization and reprocessing (EMDR) arm
arm group type: Experimental
arm group label: Progressive counting (PC) arm
arm group type: Experimental
intervention type: Behavioral
intervention name: EMDR-based Flash technique
description: Initial EMDR session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
arm group label: Eye movement desensitization and reprocessing (EMDR) arm
intervention type: Behavioral
intervention name: PC-based Flash technique
description: Initial PC session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
arm group label: Progressive counting (PC) arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ricky Greenwald, PsyD
role: Principal Investigator
affiliation: Trauma Institute & Child Trauma Institute
last name: Ricky Greenwald, PsyD
phone: 413-774-2340
email: cti@childtrauma.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Psychological Trauma