<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/NCT03764566</url>
  </required_header>
  <id_info>
    <org_study_id>GRK_B3</org_study_id>
    <nct_id>NCT03764566</nct_id>
  </id_info>
  <brief_title>Me and the Others: Expectations and Evaluation of Social Relationships</brief_title>
  <official_title>Loneliness, Social Belonging, and Adverse Childhood Experiences: &quot;Me and the Others: Expectations and Evaluation of Social Relationships&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Institute of Mental Health, Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Institute of Mental Health, Mannheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic and pervasive loneliness has been identified as an important factor in the&#xD;
      relationship between adverse childhood experiences (ACE) (e.g. abuse and neglect) and mental&#xD;
      disorders. However, the mechanisms determining loneliness after ACE are still needed to be&#xD;
      disentangled. Therefore, this study aims to investigate the differential effect of ACE on&#xD;
      alterations in cognition and the link between ACE and loneliness with an emphasis on the&#xD;
      effect of type and timing of ACE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the rationale of the detrimental effects of loneliness on mental and physical health may&#xD;
      be based on the interactions between genetic predispositions and social-environmental&#xD;
      influences (e.g. ACE) via affecting neurobiological and cognitive processing, goals of this&#xD;
      project are 1) characterization of loneliness to understand whether people suffer from&#xD;
      mental/somatic disorders, feel lonelier and this effect is particularly strong in those with&#xD;
      a history of ACE, 2) understanding the determinants of chronic loneliness by investigating&#xD;
      certain personality dispositions such as rejection sensitivity and justice sensitivity,&#xD;
      genetic predisposition for loneliness and social environments during childhood and&#xD;
      adolescence and 3) inquiring into the social-cognitive correlates of these potential&#xD;
      determinants in people's life today&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    project has been cancelled&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 31, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>University of California, Los Angeles (UCLA) Loneliness Scale</measure>
    <time_frame>10 mins</time_frame>
    <description>A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from 1 (Never) to 4 (Often). Ratings are summed up by taking the reversed items into consideration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rejection Sensitivity Questionnaire (RSQ)</measure>
    <time_frame>10 mins</time_frame>
    <description>Rejection Sensitivity Questionnaire will be used to measure the cognitive and affective components of the rejection experience, namely rejection expectancy and rejection concern. RSQ involves nine hypothetical interpersonal situations to measure how respondents would feel or think in stated situations. Items are answered on a 6-point Likert scale from 1= &quot;very unconcerned&quot; to 6= &quot;very concerned&quot; for the rejection concern and 1= &quot;very unlikely&quot; to 6= &quot;very likely&quot; for the rejection expectancy. By multiplying the results of the two levels, total rejection sensitivity score is calculated and higher scores indicate higher sensitivity to rejection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Justice Sensitivity Inventory (JSI)</measure>
    <time_frame>10 mins</time_frame>
    <description>JSI includes for questionnaire scales assessing victim, observer, beneficiary and perpetrator sensitivity on four subscales. Scores for each subscale range from 0 to 50 based on 10 items (6-point rating scale ranging from 0 to 5). Higher scores indicate a higher sensitivity to justice. JSI involves 4 each have 2 dimensions in terms of the applicability of the question for the self and the others.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Life Change Events</condition>
  <condition>Loneliness</condition>
  <arm_group>
    <arm_group_label>Trauma control group</arm_group_label>
    <description>Individuals with adverse childhood experiences (e.g.childhood abuse or neglect) will be included as the experimental group of participants. Individuals will fill out the designated questionnaires (e.g. Childhood Trauma Questionnaire, Rejection Sensitivity Questionnaire, Loneliness questionnaires), will participate in a multimodal emotion recognition experiment as well as a virtual reality (VR) task.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <description>Individuals with no trauma history will be added as the healthy control group of participants. Individuals will fill out the designated questionnaires (e.g. Childhood Trauma Questionnaire, Rejection Sensitivity Questionnaire, Loneliness questionnaires), will participate in a multimodal emotion recognition experiment as well as a virtual reality (VR) task.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical control group</arm_group_label>
    <description>Individuals with Borderline Personality Disorder (BPD) will be added as a clinical control group. Individuals will fill out the designated questionnaires (e.g. Childhood Trauma Questionnaire, Rejection Sensitivity Questionnaire, Loneliness questionnaires), will participate in a multimodal emotion recognition experiment as well as a virtual reality (VR) task.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>The intervention will include the implication of related questionnaires, followed by a lab experiment for social belonging with multiple modalities. Participants will be shown pictures of different faces and asked to judge their feelings towards them. Further, a VR task will include finding the way through a virtual maze with the help of two virtual characters.</description>
    <arm_group_label>Clinical control group</arm_group_label>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_label>Trauma control group</arm_group_label>
    <other_name>Multimodal emotion recognition task</other_name>
    <other_name>Virtual maze task with the use of Virtual Reality (VR)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who are German speaker, willing to participate in the study and meet the&#xD;
        inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy individuals with and without adverse childhood experiences + clinical control&#xD;
             group (i.e. individuals with borderline personality disorder)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A lifetime history of psychotic or bipolar I disorders, current pregnancy, history of&#xD;
             organic brain disease, skull or brain damage, or severe neurological illnesses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefanie Lis, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zentralinstitut für Seelische Gesundheit (ZI), Mannheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zentralinstitut für Seelische Gesundheit</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.grk2350.de/</url>
    <description>Official website of the research training program that this study is a part of.</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>childhood adversities</keyword>
  <keyword>childhood neglect</keyword>
  <keyword>childhood abuse</keyword>
  <keyword>rejection sensitivity</keyword>
  <keyword>justice sensitivity</keyword>
  <keyword>loneliness</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03764566
org study id: GRK_B3
nct id: NCT03764566
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic and pervasive loneliness has been identified as an important factor in the
      relationship between adverse childhood experiences (ACE) (e.g. abuse and neglect) and mental
      disorders. However, the mechanisms determining loneliness after ACE are still needed to be
      disentangled. Therefore, this study aims to investigate the differential effect of ACE on
      alterations in cognition and the link between ACE and loneliness with an emphasis on the
      effect of type and timing of ACE.
With the rationale of the detrimental effects of loneliness on mental and physical health may
      be based on the interactions between genetic predispositions and social-environmental
      influences (e.g. ACE) via affecting neurobiological and cognitive processing, goals of this
      project are 1) characterization of loneliness to understand whether people suffer from
      mental/somatic disorders, feel lonelier and this effect is particularly strong in those with
      a history of ACE, 2) understanding the determinants of chronic loneliness by investigating
      certain personality dispositions such as rejection sensitivity and justice sensitivity,
      genetic predisposition for loneliness and social environments during childhood and
      adolescence and 3) inquiring into the social-cognitive correlates of these potential
      determinants in people's life today
observational model: Case-Control
time perspective: Cross-Sectional
measure: University of California, Los Angeles (UCLA) Loneliness Scale
time frame: 10 mins
description: A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from 1 (Never) to 4 (Often). Ratings are summed up by taking the reversed items into consideration.
measure: Rejection Sensitivity Questionnaire (RSQ)
time frame: 10 mins
description: Rejection Sensitivity Questionnaire will be used to measure the cognitive and affective components of the rejection experience, namely rejection expectancy and rejection concern. RSQ involves nine hypothetical interpersonal situations to measure how respondents would feel or think in stated situations. Items are answered on a 6-point Likert scale from 1= "very unconcerned" to 6= "very concerned" for the rejection concern and 1= "very unlikely" to 6= "very likely" for the rejection expectancy. By multiplying the results of the two levels, total rejection sensitivity score is calculated and higher scores indicate higher sensitivity to rejection.
measure: Justice Sensitivity Inventory (JSI)
time frame: 10 mins
description: JSI includes for questionnaire scales assessing victim, observer, beneficiary and perpetrator sensitivity on four subscales. Scores for each subscale range from 0 to 50 based on 10 items (6-point rating scale ranging from 0 to 5). Higher scores indicate a higher sensitivity to justice. JSI involves 4 each have 2 dimensions in terms of the applicability of the question for the self and the others.
arm group label: Trauma control group
description: Individuals with adverse childhood experiences (e.g.childhood abuse or neglect) will be included as the experimental group of participants. Individuals will fill out the designated questionnaires (e.g. Childhood Trauma Questionnaire, Rejection Sensitivity Questionnaire, Loneliness questionnaires), will participate in a multimodal emotion recognition experiment as well as a virtual reality (VR) task.
arm group label: Healthy control group
description: Individuals with no trauma history will be added as the healthy control group of participants. Individuals will fill out the designated questionnaires (e.g. Childhood Trauma Questionnaire, Rejection Sensitivity Questionnaire, Loneliness questionnaires), will participate in a multimodal emotion recognition experiment as well as a virtual reality (VR) task.
arm group label: Clinical control group
description: Individuals with Borderline Personality Disorder (BPD) will be added as a clinical control group. Individuals will fill out the designated questionnaires (e.g. Childhood Trauma Questionnaire, Rejection Sensitivity Questionnaire, Loneliness questionnaires), will participate in a multimodal emotion recognition experiment as well as a virtual reality (VR) task.
intervention type: Behavioral
intervention name: Questionnaires
description: The intervention will include the implication of related questionnaires, followed by a lab experiment for social belonging with multiple modalities. Participants will be shown pictures of different faces and asked to judge their feelings towards them. Further, a VR task will include finding the way through a virtual maze with the help of two virtual characters.
arm group label: Clinical control group
arm group label: Healthy control group
arm group label: Trauma control group
other name: Multimodal emotion recognition task
other name: Virtual maze task with the use of Virtual Reality (VR)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefanie Lis, PD Dr.
role: Principal Investigator
affiliation: Zentralinstitut für Seelische Gesundheit (ZI), Mannheim
facility: 
country: Germany
url: http://www.grk2350.de/
description: Official website of the research training program that this study is a part of.
responsible party type: Sponsor
sharing ipd: Undecided