Me and the Others: Expectations and Evaluation of Social Relationships

NCT03764566 | Withdrawn

• 1 other identifier: GRK_B3
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Life Change Events; Loneliness

Keywords

childhood adversities; childhood neglect; childhood abuse; rejection sensitivity; justice sensitivity; loneliness

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

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

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

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

Interventions

Questionnaires BEHAVIORAL

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.

Also known as: Multimodal emotion recognition task, Virtual maze task with the use of Virtual Reality (VR)

Clinical control group; Healthy control group; Trauma control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• German Research Foundation: collaborator

Study Sites (1)

Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Links

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

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stefanie Lis, PD Dr.

  Zentralinstitut für Seelische Gesundheit (ZI), Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 5, 2018
• Study Start: January 31, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

DE (1)