<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/NCT01721356</url>
  </required_header>
  <id_info>
    <org_study_id>W81XWH-09-1-0730</org_study_id>
    <nct_id>NCT01721356</nct_id>
  </id_info>
  <brief_title>Neurobiological Basis of Emotional Intelligence</brief_title>
  <acronym>EQ</acronym>
  <official_title>The Neurobiological Basis and Potential Modification of Emotional Intelligence Through Affective / Behavioral Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emotional Intelligence (EI) is defined as the ability to accurately perceive and identify&#xD;
      emotions in oneself and others, understand and use emotions to enhance cognitive processes,&#xD;
      and effectively manage one's own emotions as well as those of others. Two major approaches to&#xD;
      the construct of emotional intelligence have emerged. These two approaches can be broadly&#xD;
      defined as the Trait and Ability Approaches. The Trait Approach, which is typically assessed&#xD;
      via self-report measures such as that Bar-On Emotional Quotient Inventory, appears to be&#xD;
      strongly related to existing models of personality and coping. The other major approach to EI&#xD;
      follows an Ability Model, assuming that EI is similar to but distinct from other types of&#xD;
      cognitive intelligence, and involves measurement of a variety of skills and abilities related&#xD;
      to emotional processing. An understanding of the neurobiological substrate of emotional&#xD;
      intelligence is beginning to emerge. One influential theory that is particularly relevant to&#xD;
      the neurobiology of emotional intelligence is the &quot;somatic marker hypothesis,&quot; yet there&#xD;
      still remains a limited understanding of the neurobiological basis of EI. The proposed&#xD;
      investigation will attempt to provide the most comprehensive study to date examining the&#xD;
      behavioral, psychological, functional, and brain structural correlates of EI. The proposed&#xD;
      study will use neuroimaging techniques to examine the relationship between current measures&#xD;
      of EI, behavioral expression of emotionally competent capacities, brain functional responses,&#xD;
      and structural cerebral organization.&#xD;
&#xD;
      The specific questions to be addressed and their associated hypotheses are:&#xD;
&#xD;
        1. The two major approaches to EI (i.e., Trait vs. Ability) will show only modest, though&#xD;
           significant positive correlations with one another.&#xD;
&#xD;
        2. EI Trait measures will be highly correlated with measures of personality but weakly&#xD;
           correlated with specific skills such as facial affect identification, emotional&#xD;
           decision-making, and affectively based judgments, whereas EI Ability measures will&#xD;
           correlate more highly with specific emotional skill measures.&#xD;
&#xD;
        3. During functional MRI affective challenge tasks, EI scores will be negatively correlated&#xD;
           with activity within the Somatic Marker Circuitry suggested by Damasio and colleagues&#xD;
           (i.e., ventromedial prefrontal cortex, amygdala, insular cortex), as suggested by the&#xD;
           neural efficiency hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Score on ability measure (MSCEIT) of emotional intelligence</measure>
    <time_frame>Measure administered on the day of the MRI scan</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Emotional Intelligence</condition>
  <arm_group>
    <arm_group_label>Healthy individuals</arm_group_label>
    <description>Healthy individuals ranging in age, race, ethnicity, socioeconomic status, and years of education</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Between 70 and 80 healthy, English speaking, right-handed, adults between the ages of 18&#xD;
        and 45 participated. Attempts were made to include equal numbers of men and women to permit&#xD;
        the broadest generalization to the population and to permit direct assessment of gender&#xD;
        effects, an issue that has received considerable attention recently regarding the&#xD;
        neurobiology of affective processes. Subjects were not excluded on the basis of ethnicity,&#xD;
        gender, or sexual orientation. Healthy participants were recruited via local&#xD;
        advertisements, including email broadcasts such as the Harvard Hospital and Partners&#xD;
        Healthcare systems, internet advertisements, and posting of IRB-approved flyers in various&#xD;
        community centers. IRB-approved print advertisements were posted in local newspapers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range between 18 and 45&#xD;
&#xD;
          -  Right handed&#xD;
&#xD;
          -  Primary language must be English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of neurological illness, current DSM-IV Axis I disorder, lifetime history&#xD;
             of major depression or psychotic disorder, or head injury with loss of consciousness &gt;&#xD;
             30 minutes&#xD;
&#xD;
          -  Complicating medical conditions that may influence the outcome of neuropsychological&#xD;
             assessment or functional imaging (e.g., HIV)&#xD;
&#xD;
          -  Mixed or left-handedness&#xD;
&#xD;
          -  Current score of 15 or greater on Beck Depression Inventory&#xD;
&#xD;
          -  Abnormal visual acuity that is not corrected by contact lenses&#xD;
&#xD;
          -  Metal within the body, claustrophobia, or other contraindications for neuroimaging&#xD;
&#xD;
          -  Less than 9th grade education&#xD;
&#xD;
          -  Evidence of impaired reading comprehension&#xD;
&#xD;
          -  Excess alcohol use (Males: regular intake of 5+ drinks on one occasion or &gt;2 drinks&#xD;
             per day on average for past 2 months; Females: 4+ drinks per day or &gt;1 drink per day&#xD;
             on average for past 2 months)&#xD;
&#xD;
          -  History of alcoholism or substance use disorder&#xD;
&#xD;
          -  Use of illicit drugs&#xD;
&#xD;
          -  Best of 4 learning trials of Memory Suppression Task Training below 85%&#xD;
&#xD;
          -  Indication of invalid responding, potentially including elevated Omission Rate,&#xD;
             Inconsistency Index, or Positive/Negative Impression scales on EQi, or elevated&#xD;
             Omission Rate or Scatter score on MSCEIT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William D Killgore, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>November 1, 2012</last_update_submitted>
  <last_update_submitted_qc>November 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>William Killgore</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01721356
org study id: W81XWH-09-1-0730
nct id: NCT01721356
lead sponsor: 
has dmc: No
Emotional Intelligence (EI) is defined as the ability to accurately perceive and identify
      emotions in oneself and others, understand and use emotions to enhance cognitive processes,
      and effectively manage one's own emotions as well as those of others. Two major approaches to
      the construct of emotional intelligence have emerged. These two approaches can be broadly
      defined as the Trait and Ability Approaches. The Trait Approach, which is typically assessed
      via self-report measures such as that Bar-On Emotional Quotient Inventory, appears to be
      strongly related to existing models of personality and coping. The other major approach to EI
      follows an Ability Model, assuming that EI is similar to but distinct from other types of
      cognitive intelligence, and involves measurement of a variety of skills and abilities related
      to emotional processing. An understanding of the neurobiological substrate of emotional
      intelligence is beginning to emerge. One influential theory that is particularly relevant to
      the neurobiology of emotional intelligence is the "somatic marker hypothesis," yet there
      still remains a limited understanding of the neurobiological basis of EI. The proposed
      investigation will attempt to provide the most comprehensive study to date examining the
      behavioral, psychological, functional, and brain structural correlates of EI. The proposed
      study will use neuroimaging techniques to examine the relationship between current measures
      of EI, behavioral expression of emotionally competent capacities, brain functional responses,
      and structural cerebral organization.

      The specific questions to be addressed and their associated hypotheses are:

        1. The two major approaches to EI (i.e., Trait vs. Ability) will show only modest, though
           significant positive correlations with one another.

        2. EI Trait measures will be highly correlated with measures of personality but weakly
           correlated with specific skills such as facial affect identification, emotional
           decision-making, and affectively based judgments, whereas EI Ability measures will
           correlate more highly with specific emotional skill measures.

        3. During functional MRI affective challenge tasks, EI scores will be negatively correlated
           with activity within the Somatic Marker Circuitry suggested by Damasio and colleagues
           (i.e., ventromedial prefrontal cortex, amygdala, insular cortex), as suggested by the
           neural efficiency hypothesis.
observational model: Cohort
time perspective: Cross-Sectional
measure: Score on ability measure (MSCEIT) of emotional intelligence
time frame: Measure administered on the day of the MRI scan
arm group label: Healthy individuals
description: Healthy individuals ranging in age, race, ethnicity, socioeconomic status, and years of education
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William D Killgore, PhD
role: Principal Investigator
affiliation: Mclean Hospital
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: William Killgore
investigator title: Associate Professor