Life Change EventsNCT03764566
Me and the Others: Expectations and Evaluation of Social Relationships
An observational study of Life Change Events and Loneliness, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Change Events, Loneliness
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals who are German speaker, willing to participate in the study and meet the inclusion criteria.
Who may be able to join
- Healthy individuals with and without adverse childhood experiences + clinical control group (i.e. individuals with borderline personality disorder)
Who cannot join
- A lifetime history of psychotic or bipolar I disorders, current pregnancy, history of organic brain disease, skull or brain damage, or severe neurological illnesses.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: 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.
Read the 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
- Conditions
- Life Change Events, Loneliness
- Being tested
- Questionnaires
- Keywords
- childhood adversities, childhood neglect, childhood abuse, rejection sensitivity, justice sensitivity, loneliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Multimodal emotion recognition task, Virtual maze task with the use of Virtual Reality (VR)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start31 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Why it stopped: project has been cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life Change EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Stefanie Lis, PD Dr., Principal investigator, Zentralinstitut für Seelische Gesundheit (ZI), Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764566
- Sponsor's protocol ID
- GRK_B3
- Status last verified
- Feb 2020
- First submitted
- 27 Nov 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loneliness, Social Belonging, and Adverse Childhood Experiences: "Me and the Others: Expectations and Evaluation of Social Relationships"
- ClinicalTrials.gov ID
- NCT03764566
- Acronym / sponsor ID
- GRK_B3
- Conditions
- Life Change Events, Loneliness
- Keywords
- childhood adversities, childhood neglect, childhood abuse, rejection sensitivity, justice sensitivity, loneliness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: project has been cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 31 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trauma control group | – | Behavioral: QuestionnairesIndividuals 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. |
| Healthy control group | – | Behavioral: QuestionnairesIndividuals 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. |
| Clinical control group | – | Behavioral: QuestionnairesIndividuals 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals who are German speaker, willing to participate in the study and meet the inclusion criteria.
Key inclusion criteria (1 listed)
- Healthy individuals with and without adverse childhood experiences + clinical control group (i.e. individuals with borderline personality disorder)
Key exclusion criteria (1 listed)
- A lifetime history of psychotic or bipolar I disorders, current pregnancy, history of organic brain disease, skull or brain damage, or severe neurological illnesses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: Multimodal emotion recognition task, Virtual maze task with the use of Virtual Reality (VR)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. | Behavioural | Clinical control group, Healthy control group, Trauma control group |
Primary outcome
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Official website of the research training program that this study is a part of.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Life Change Events
Active, not recruiting
Longitudinal Study of Neighborhood Social Event Attendance at Renovated Parks and Changes in Sleep, Stress, and Well-being
Sleep, Well-being
RecruitingObservational study
Impact of the Coronavirus (COVID-19) on Patients With Cancer
Cancer, COVID-19
Not yet recruitingObservational study
Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study
Infant, Premature, Infant, Low Birth Weight
RecruitingObservational study
The Lake Nona Life Project
Health Behavior, Quality of Life
RecruitingObservational study
Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults
Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanie Lis, PD Dr. principal investigator
Zentralinstitut für Seelische Gesundheit (ZI), Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Life Change Events and Loneliness, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of California, Los Angeles (UCLA) Loneliness Scale (time frame: 10 mins). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.