<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/NCT03271437</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1003</org_study_id>
    <nct_id>NCT03271437</nct_id>
  </id_info>
  <brief_title>Flash Open Trial With Therapists In Training</brief_title>
  <official_title>Flash Open Trial With Therapists In Training</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 study will test the eye movement desensitization and reprocessing (EMDR) based Flash&#xD;
      technique and a progressive counting (PC) based variant. EMDR-trained therapists will be&#xD;
      trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each&#xD;
      group they will try it with a minor upsetting memory, and then with two more significant&#xD;
      upsetting memories. Participants will use the subjective units of distress scale (SUDS) to&#xD;
      rate distress pre- and post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SUDS following treatment</measure>
    <time_frame>Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment</time_frame>
    <description>Subjective units of distress scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Trauma, Psychological</condition>
  <arm_group>
    <arm_group_label>PC-trained therapists</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>EMDR-trained therapists</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PC-based Flash</intervention_name>
    <description>Progressive counting with Flash technique</description>
    <arm_group_label>PC-trained therapists</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EMDR-based Flash</intervention_name>
    <description>Eye movement desensitization and reprocessing with Flash technique</description>
    <arm_group_label>EMDR-trained therapists</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Therapist trained by Trauma Institute &amp; Child Trauma Institute in EMDR or PC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>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/NCT03271437
org study id: 2017-1003
nct id: NCT03271437
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will test the eye movement desensitization and reprocessing (EMDR) based Flash
      technique and a progressive counting (PC) based variant. EMDR-trained therapists will be
      trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each
      group they will try it with a minor upsetting memory, and then with two more significant
      upsetting memories. Participants will use the subjective units of distress scale (SUDS) to
      rate distress pre- and post-treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in SUDS following treatment
time frame: Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment
description: Subjective units of distress scale
arm group label: PC-trained therapists
arm group type: Experimental
arm group label: EMDR-trained therapists
arm group type: Experimental
intervention type: Behavioral
intervention name: PC-based Flash
description: Progressive counting with Flash technique
arm group label: PC-trained therapists
intervention type: Behavioral
intervention name: EMDR-based Flash
description: Eye movement desensitization and reprocessing with Flash technique
arm group label: EMDR-trained therapists
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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: Psychological Trauma