Clinical trial NCT03764566: Me and the Others: Expectations and Evaluation of Social Relationships
Official title: Loneliness, Social Belonging, and Adverse Childhood Experiences: "Me and the Others: Expectations and Evaluation of Social Relationships"
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Life Change Events
Loneliness
Keywords: childhood adversities
childhood neglect
childhood abuse
rejection sensitivity
justice sensitivity
loneliness
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2018-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are German speaker, willing to participate in the study and meet the inclusion criteria.

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.

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

Eligibility 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.

Primary outcomes:
measure: University of California, Los Angeles (UCLA) Loneliness Scale
timeFrame: 10 mins
measure: Rejection Sensitivity Questionnaire (RSQ)
timeFrame: 10 mins
measure: Justice Sensitivity Inventory (JSI)
timeFrame: 10 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit
state: Baden-Württemberg
Study officials:
affiliation: Zentralinstitut für Seelische Gesundheit (ZI), Mannheim
name: Stefanie Lis, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: