- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764566
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Withdrawn
Conditions
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:
|
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:
|
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:
|
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.
Collaborators
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
Keywords
Other Study ID Numbers
- GRK_B3
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.
Clinical Trials on Loneliness
-
University of RochesterNational Institute on Aging (NIA)Recruiting
-
Vladimíra DostálováBarcelona Institute for Global HealthRecruiting
-
Taipei Medical UniversityCompleted
-
Linkoeping UniversityUniversity College, LondonCompleted
-
KTO Karatay UniversityCompleted
-
Florida State UniversityCompleted
-
Heartfulness InstituteCompletedLonelinessUnited States
-
Trustees of Dartmouth CollegeRecruiting
-
University of OregonNational Institute on Drug Abuse (NIDA); HopeLab FoundationCompleted
Clinical Trials on Questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount Sinai; Hackensack Meridian Health; Derald H...CompletedLeukemia | Multiple Myeloma | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States