<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/NCT04408274</url>
  </required_header>
  <id_info>
    <org_study_id>R-764-13</org_study_id>
    <nct_id>NCT04408274</nct_id>
  </id_info>
  <brief_title>Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury</brief_title>
  <official_title>Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury: A Piolt Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kessler Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kessler Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the efficacy of a clinical intervention for improving emotional&#xD;
      processing in individuals with MS and TBI.(1)The main outcome measure will be changes in&#xD;
      emotional processing measures from pre to post treatment.&#xD;
&#xD;
      (2)This study will also assess the impact of the emotional processing intervention on changes&#xD;
      in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will&#xD;
      additionally measure the impact of the emotional processing intervention on cognitive&#xD;
      functioning, specifically processing speed, attention and executive abilities. This will be&#xD;
      accomplished through the completion of a neuropsychological battery prior to and following&#xD;
      the completion of treatment.(4)Finally, the investigators will measure the impact of the&#xD;
      intervention on quality of life and social functioning, utilizing a pre and post treatment&#xD;
      assessment consisting of measures of self-efficacy, quality of life, functional abilities,&#xD;
      and awareness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in scores on Facial Expression Identification Task (FEIT)</measure>
    <time_frame>Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)</time_frame>
    <description>The FEIT assesses one's ability to correctly identify and discriminate emotions from faces</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in scores on Emotion Regulation Questionnaire (ERQ)</measure>
    <time_frame>Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)</time_frame>
    <description>The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)</time_frame>
    <description>The SWLS is a self-report measure of quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Computerized Tests</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotional Processing Training</intervention_name>
    <arm_group_label>Computerized Tests</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo Control</intervention_name>
    <arm_group_label>Placebo Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Multiple Sclerosis or Traumatic Brain Injury&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  processing speed impairment (based on evaluation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently taking steroids and/or benzodiazepines&#xD;
&#xD;
          -  prior stroke or neurological diease&#xD;
&#xD;
          -  history of significant pyschiatric illness (for example, bipolar disorder,&#xD;
             schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder,&#xD;
             Schizophrenia, Epilepsy, Bipolar Disorder&#xD;
&#xD;
          -  significant alcohol or drug abuse history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kessler Foundation</name>
      <address>
        <city>East Hanover</city>
        <state>New Jersey</state>
        <zip>07936</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>April 17, 2018</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kessler Foundation</investigator_affiliation>
    <investigator_full_name>Jean Lengenfelder</investigator_full_name>
    <investigator_title>Associate Director, Traumatic Brain Injury Lab</investigator_title>
  </responsible_party>
  <keyword>Processing Speed</keyword>
  <keyword>Intervention</keyword>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04408274
org study id: R-764-13
nct id: NCT04408274
lead sponsor: 
has dmc: No
This study will examine the efficacy of a clinical intervention for improving emotional
      processing in individuals with MS and TBI.(1)The main outcome measure will be changes in
      emotional processing measures from pre to post treatment.

      (2)This study will also assess the impact of the emotional processing intervention on changes
      in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will
      additionally measure the impact of the emotional processing intervention on cognitive
      functioning, specifically processing speed, attention and executive abilities. This will be
      accomplished through the completion of a neuropsychological battery prior to and following
      the completion of treatment.(4)Finally, the investigators will measure the impact of the
      intervention on quality of life and social functioning, utilizing a pre and post treatment
      assessment consisting of measures of self-efficacy, quality of life, functional abilities,
      and awareness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in scores on Facial Expression Identification Task (FEIT)
time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
description: The FEIT assesses one's ability to correctly identify and discriminate emotions from faces
measure: Change in scores on Emotion Regulation Questionnaire (ERQ)
time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
description: The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression
measure: Change in scores on Satisfaction with Life Scale (SWLS)
time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
description: The SWLS is a self-report measure of quality of life
arm group label: Computerized Tests
arm group type: Experimental
arm group label: Placebo Control
arm group type: Placebo Comparator
intervention type: Behavioral
intervention name: Emotional Processing Training
arm group label: Computerized Tests
intervention type: Behavioral
intervention name: Placebo Control
arm group label: Placebo Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Kessler Foundation
investigator full name: Jean Lengenfelder
investigator title: Associate Director, Traumatic Brain Injury Lab
mesh term: Multiple Sclerosis
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Sclerosis
mesh term: Wounds and Injuries