Me and the Others: Expectations and Evaluation of Social Relationships

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03764566
• Other study ID #: GRK_B3
• Status: Withdrawn
• Start date: January 31, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2020
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Life Change Events
• Loneliness

Intervention

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.

Locations

Country	Name	City	State
Germany	Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	University of California, Los Angeles (UCLA) Loneliness Scale	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
Primary	Rejection Sensitivity Questionnaire (RSQ)	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
Primary	Justice Sensitivity Inventory (JSI)	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

External Links

•   Official website of the research training program that this study is a part of.