<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/NCT03271398</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1001</org_study_id>
    <nct_id>NCT03271398</nct_id>
  </id_info>
  <brief_title>Intensive Therapy Archival Research</brief_title>
  <official_title>Intensive Therapy Archival Research</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 internal treatment evaluation to determine whether eye movement desensitization&#xD;
      and reprocessing (EMDR) or progressive counting (PC) should become the preferred trauma&#xD;
      treatment for the investigator's clients. The investigator is using routine/existing in-house&#xD;
      measures and case files to track symptom reduction, trauma treatment time, rate of treatment&#xD;
      switching (from EMDR to PC or vice versa), and rate of trauma treatment refusal. This is&#xD;
      retrospective as well as prospective archival research.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>12 Weeks</target_duration>
  <primary_outcome>
    <measure>Change in TSI-2 following treatment</measure>
    <time_frame>Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment</time_frame>
    <description>Trauma Symptom Inventory-2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in TSCC following treatment</measure>
    <time_frame>Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment</time_frame>
    <description>Trauma Symptom Checklist for Children</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>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Trauma, Psychological</condition>
  <arm_group>
    <arm_group_label>Adult victims of sexual assault</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Children who have been exposed to domestic abuse</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Women with perinatal emotional complications</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Teens with behavior problems and histories of abuse</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Veterans with military-related trauma</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Survivors of intimate partner violence</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EMDR</intervention_name>
    <description>Eye movement desensitization and reprocessing (intensive format)</description>
    <arm_group_label>Adult victims of sexual assault</arm_group_label>
    <arm_group_label>Children who have been exposed to domestic abuse</arm_group_label>
    <arm_group_label>Survivors of intimate partner violence</arm_group_label>
    <arm_group_label>Teens with behavior problems and histories of abuse</arm_group_label>
    <arm_group_label>Veterans with military-related trauma</arm_group_label>
    <arm_group_label>Women with perinatal emotional complications</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PC</intervention_name>
    <description>Progressive counting (intensive format)</description>
    <arm_group_label>Adult victims of sexual assault</arm_group_label>
    <arm_group_label>Children who have been exposed to domestic abuse</arm_group_label>
    <arm_group_label>Survivors of intimate partner violence</arm_group_label>
    <arm_group_label>Teens with behavior problems and histories of abuse</arm_group_label>
    <arm_group_label>Veterans with military-related trauma</arm_group_label>
    <arm_group_label>Women with perinatal emotional complications</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All participants in the Trauma Institute &amp; Child Trauma Institute Victims of Crime program&#xD;
        will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Victims of crimes, including assault, rape, robbery, intimate partner violence, child&#xD;
             abuse, kidnapping, vehicular homicide, and suicide&#xD;
&#xD;
          -  Witnesses and family members of victims&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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/NCT03271398
org study id: 2017-1001
nct id: NCT03271398
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is an internal treatment evaluation to determine whether eye movement desensitization
      and reprocessing (EMDR) or progressive counting (PC) should become the preferred trauma
      treatment for the investigator's clients. The investigator is using routine/existing in-house
      measures and case files to track symptom reduction, trauma treatment time, rate of treatment
      switching (from EMDR to PC or vice versa), and rate of trauma treatment refusal. This is
      retrospective as well as prospective archival research.
observational model: Cohort
time perspective: Other
measure: Change in TSI-2 following treatment
time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
description: Trauma Symptom Inventory-2
measure: Change in TSCC following treatment
time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
description: Trauma Symptom Checklist for Children
measure: Change in PRS following treatment
time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
description: Problem Rating Scale
arm group label: Adult victims of sexual assault
arm group label: Children who have been exposed to domestic abuse
arm group label: Women with perinatal emotional complications
arm group label: Teens with behavior problems and histories of abuse
arm group label: Veterans with military-related trauma
arm group label: Survivors of intimate partner violence
intervention type: Behavioral
intervention name: EMDR
description: Eye movement desensitization and reprocessing (intensive format)
arm group label: Adult victims of sexual assault
arm group label: Children who have been exposed to domestic abuse
arm group label: Survivors of intimate partner violence
arm group label: Teens with behavior problems and histories of abuse
arm group label: Veterans with military-related trauma
arm group label: Women with perinatal emotional complications
intervention type: Behavioral
intervention name: PC
description: Progressive counting (intensive format)
arm group label: Adult victims of sexual assault
arm group label: Children who have been exposed to domestic abuse
arm group label: Survivors of intimate partner violence
arm group label: Teens with behavior problems and histories of abuse
arm group label: Veterans with military-related trauma
arm group label: Women with perinatal emotional complications
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
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