Me and the Others: Expectations and Evaluation of Social Relationships

February 13, 2020 updated by: Central Institute of Mental Health, Mannheim

Loneliness, Social Belonging, and Adverse Childhood Experiences: "Me and the Others: Expectations and Evaluation of Social Relationships"

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68159
        • Zentralinstitut für seelische Gesundheit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals who are German speaker, willing to participate in the study and meet the inclusion criteria.

Description

Inclusion Criteria:

  • Healthy individuals with and without adverse childhood experiences + clinical control group (i.e. individuals with borderline personality disorder)

Exclusion Criteria:

  • A lifetime history of psychotic or bipolar I disorders, current pregnancy, history of organic brain disease, skull or brain damage, or severe neurological illnesses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trauma control group
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.
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.
Other Names:
  • Multimodal emotion recognition task
  • Virtual maze task with the use of Virtual Reality (VR)
Healthy control group
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.
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.
Other Names:
  • Multimodal emotion recognition task
  • Virtual maze task with the use of Virtual Reality (VR)
Clinical control group
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.
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.
Other Names:
  • Multimodal emotion recognition task
  • Virtual maze task with the use of Virtual Reality (VR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
University of California, Los Angeles (UCLA) Loneliness Scale
Time Frame: 10 mins
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.
10 mins
Rejection Sensitivity Questionnaire (RSQ)
Time Frame: 10 mins
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.
10 mins
Justice Sensitivity Inventory (JSI)
Time Frame: 10 mins
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.
10 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stefanie Lis, PD Dr., Zentralinstitut für Seelische Gesundheit (ZI), Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 31, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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