<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/NCT01723410</url>
  </required_header>
  <id_info>
    <org_study_id>GGSC-GRAT</org_study_id>
    <nct_id>NCT01723410</nct_id>
  </id_info>
  <brief_title>Neural and Physiological Responses to Real-World Experiences</brief_title>
  <official_title>Neural and Physiological Responses to Real-World Experiences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with&#xD;
      internet access, are not pregnant, planning to become pregnant, or currently breastfeeding&#xD;
      (if female), to participate in a study investigating whether real-world experiences alter the&#xD;
      brain and body. This study takes place over an eight week period and involves providing the&#xD;
      names of 8 close friends or family members, completing a neuroimaging session, providing&#xD;
      blood and saliva (for genetic analysis), and a 6-week period in which participants login&#xD;
      twice a week to complete online questionnaires. Compensation is up to $210 for those who&#xD;
      complete all aspects of the study. Please email realworld.ucla@gmail.com for more&#xD;
      information.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>inflammatory gene expression</measure>
    <time_frame>baseline, six weeks post manipulation</time_frame>
    <description>Changes in inflammatory gene expression from pre- to post-intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neural activity</measure>
    <time_frame>baseline, six weeks post-intervention</time_frame>
    <description>Changes in neural activity from pre- to post-intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Gene Expression</condition>
  <arm_group>
    <arm_group_label>Writing condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be asked to write about other individuals in their lives.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Writing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be asked to write about places or objects in their lives.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Writing about people</intervention_name>
    <description>Subjects will be asked to write about other people in their lives once a week for 6-weeks.</description>
    <arm_group_label>Writing condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Writing about places, objects</intervention_name>
    <arm_group_label>Writing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults between the ages of 35-50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Following a structured telephone interview, prospective participants with the following&#xD;
        conditions will not be able to participate:&#xD;
&#xD;
          1. claustrophobia, left-handedness, or presence of metal in their body (for the&#xD;
             neuroimaging procedures),&#xD;
&#xD;
          2. possible presence of a depressive disorder, which may interfere with the gratitude&#xD;
             intervention (assessed by the Patient Health Questionnaire; Spitzer et al., 1999),&#xD;
&#xD;
          3. regular use of medications that may impact inflammatory processes (anti-inflammatory&#xD;
             drugs, steroids, opioids),&#xD;
&#xD;
          4. current smokers or excessive caffeine users (&gt; 600 mg/day) because of known effects on&#xD;
             inflammation, and&#xD;
&#xD;
          5. pregnancy (which would affect oxytocin gene expression).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi I Eisenberger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA CTRC &amp; Brain Mapping Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Naomi Eisenberger</investigator_full_name>
    <investigator_title>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/NCT01723410
org study id: GGSC-GRAT
nct id: NCT01723410
lead sponsor: 
has dmc: Yes
UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with
      internet access, are not pregnant, planning to become pregnant, or currently breastfeeding
      (if female), to participate in a study investigating whether real-world experiences alter the
      brain and body. This study takes place over an eight week period and involves providing the
      names of 8 close friends or family members, completing a neuroimaging session, providing
      blood and saliva (for genetic analysis), and a 6-week period in which participants login
      twice a week to complete online questionnaires. Compensation is up to $210 for those who
      complete all aspects of the study. Please email realworld.ucla@gmail.com for more
      information.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: inflammatory gene expression
time frame: baseline, six weeks post manipulation
description: Changes in inflammatory gene expression from pre- to post-intervention.
measure: neural activity
time frame: baseline, six weeks post-intervention
description: Changes in neural activity from pre- to post-intervention.
arm group label: Writing condition
arm group type: Experimental
description: Subjects will be asked to write about other individuals in their lives.
arm group label: Writing
arm group type: Placebo Comparator
description: Subjects will be asked to write about places or objects in their lives.
intervention type: Behavioral
intervention name: Writing about people
description: Subjects will be asked to write about other people in their lives once a week for 6-weeks.
arm group label: Writing condition
intervention type: Other
intervention name: Writing about places, objects
arm group label: Writing
criteria: 
gender: All
minimum age: 35 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naomi I Eisenberger, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Naomi Eisenberger
investigator title: Professor