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Trial record 3 of 8 for:    Not yet recruiting Studies | Loneliness

Me and the Others: Expectations and Evaluation of Social Relationships

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ClinicalTrials.gov Identifier: NCT03764566
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Brief Summary:
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.

Condition or disease Intervention/treatment
Life Change Events Loneliness Behavioral: Questionnaires

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

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Loneliness, Social Belonging, and Adverse Childhood Experiences: "Me and the Others: Expectations and Evaluation of Social Relationships"
Estimated Study Start Date : July 31, 2019
Estimated Primary Completion Date : April 13, 2020
Estimated Study Completion Date : March 31, 2021

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.
Behavioral: Questionnaires
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.
Behavioral: Questionnaires
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.
Behavioral: Questionnaires
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)




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals who are German speaker, willing to participate in the study and meet the inclusion criteria.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764566


Contacts
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Contact: Ezgi Erol, M.Sc. +496211703 ext 4409 ezgi.erol@zi-mannheim.de
Contact: Konstantina Atanasova, M.Sc. +496211703 ext 4409 konstantina.atanasova@zi-mannheim.de

Locations
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Germany
Zentralinstitut für Seelische Gesundheit Not yet recruiting
Mannheim, Baden-Württemberg, Germany, 68159
Contact: Stefanie Engelhardt, Dr.rer.nat.    +496211703 ext 1326    stefanie.engelhardt@zi-mannheim.de   
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Research Foundation
Investigators
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Principal Investigator: Stefanie Lis, PD Dr. Zentralinstitut für Seelische Gesundheit (ZI), Mannheim

Additional Information:
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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT03764566     History of Changes
Other Study ID Numbers: GRK_B3
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Institute of Mental Health, Mannheim:
childhood adversities
childhood neglect
childhood abuse
rejection sensitivity
justice sensitivity
loneliness