- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350515
Effects of Social Exclusion in The Context of Chronic Embitterment (EMBEX)
March 27, 2023 updated by: University of Bern
Effects of Social Exclusion in The Context of Chronic Embitterment: How Social Exclusion Experiences Affect Chronic Embittered People in Their Behaviour and Physiology
This experimental, anonymous labor study aims to examine how experiences of social exclusion influence individuals in their fairness-behaviour, psychophysical reactions, and emotion regulation depending on their extent of bitterness.
Points given for fairness reasons, just world belief, rejection sensitivity, well-being, cognitive emotion regulation strategies, and heart rate variability (HRV) are measured and analyzed using structural equation modeling and multiple regression.
Study Overview
Status
Completed
Conditions
Detailed Description
Embitterment is defined as an emotional response due to an event which is subjectively perceived as unjust.
Nonetheless, there is little empiric evidence of unjust behaviour by others in the interpersonal context that triggers embitterment reactions.
Ostracism, is an act where a person is excluded from a social environment without any reasons.
This experimental labor study examines how the experiences of this form of social exclusion influences individuals depending on their self-evaluated embitterment.
That is, fairness-behaviour is assessed as well as changes in hearth rate variability.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
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
-
-
BE
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Bern, BE, Switzerland, 3012
- University of Bern, Institute of Psychology
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- German language, 18 years old, no cardiovascular disease
- The participation in the anonymous labor study is voluntary, participants gave consent to use the data with their participation.
Exclusion Criteria:
- None
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cyberball: Other Exclusion
Cyberball Paradigm - the avatar will be excluded by the player
|
A cyberball paradigm, whereas 2 avatars and the subject are playing a virtual ball tossing game.
In this condition, one of the avatars is excluded.
Other Names:
In this task, subjects listen to an audio file containing a scripted emotion regulation exercise.
This exercise is based by the authors Nissen & Sturm (2018).
It takes around 14 minutes to complete the whole task.
Other Names:
In this task, subjects listen to an audio file containing a scripted word recognition exercise.
It contains both contrary words recognition (e.g.
"The opposite of loud is ...") and completion of german sayings (e.g.
"That's where the dog is...").
It takes around 14 minutes to complete the whole task.
Other Names:
|
|
Experimental: Cyberball: Player Exclusion
Cyberball Paradigm - the player will be excluded by the other players
|
In this task, subjects listen to an audio file containing a scripted emotion regulation exercise.
This exercise is based by the authors Nissen & Sturm (2018).
It takes around 14 minutes to complete the whole task.
Other Names:
In this task, subjects listen to an audio file containing a scripted word recognition exercise.
It contains both contrary words recognition (e.g.
"The opposite of loud is ...") and completion of german sayings (e.g.
"That's where the dog is...").
It takes around 14 minutes to complete the whole task.
Other Names:
A cyberball paradigm, whereas 2 avatars and the subject are playing a virtual ball tossing game.
In this condition, the subject is excluded by the avatars.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Points for Fairness
Time Frame: After the second Cyberball intervention (exclusion of the subject or the avatar), at approx. 30 minutes from baseline.
|
Asked after the second Cyberball game session.
Each participant will be asked, how many of their "earned" points (from the first Cyberball round) they are willing to compensate for fairness reasons towards the group.
This is assessed by a Likert scale ranging from 0 - 14; giving zero points it the least one can give, 14 is the maximum.
|
After the second Cyberball intervention (exclusion of the subject or the avatar), at approx. 30 minutes from baseline.
|
|
Changes in Heart Rate Variability (HRV; RMSSD) from baseline (t0)
Time Frame: After approx. 15, 20, 25, 30, 35, 40, 45, and 50 minutes from baseline.
|
Changes in Heart Rate Variability (RMSSDs) are assessed using the hardware of BIOPAC Systems.
The extraction and analysis of the RMSSDs are performed with Kubios HRV premium (software).
|
After approx. 15, 20, 25, 30, 35, 40, 45, and 50 minutes from baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Belief in a Just World
Time Frame: Baseline questionnaires at the beginning of the experiment.
|
Belief in a Just World is assessed using the german version of the "Beliefs in a just world questionnaire" (Dalbert, Montada, & Schmitt, 1987).
It contains six items, ranging from 1-6, whereas lower numbers indicate a lower belief in a just/rightful world and vice versa.
|
Baseline questionnaires at the beginning of the experiment.
|
|
Rejection Sensitivity
Time Frame: Baseline questionnaires at the beginning of the experiment.
|
Rejection Sensitivity is assessed using the german version of the "Rejection Sensitivity Questionnaire" (Feldman & Downey, 1994) - based on 18 items describe interpersonal interactions, where the subject has to ask someone to do something for him or her, further how much distress these interactions would provoke and the other person would decline the request.
Each item can be answered on a Likert-Scale from 1-6, whereas lower numbers indicate less personal distress and expected rejection by the interacting person when being in that particular scenario.
Higher Numbers indicate more distress from the scenario as well as the more is a rejection expected.
|
Baseline questionnaires at the beginning of the experiment.
|
|
Cognitive Emotion Regulation (Strategies) - Basic
Time Frame: Baseline questionnaires at the beginning of the experiment.
|
Emotion Regulation are assessed using the german version of the "Emotion Regulation Questionnaire" (ERQ; Gross & John, 2003; Abler & Kessler, 2011).
This questionnaire assesses basic tendencies of the two strategies "reappraisal" and/or "Suppression" with regards to emotion regulation.
It has 10 items which can be answered based on a Likert-Scale ranging from 1 - 7. The higher the number the more the person tends to use this particular strategy and vice versa.
|
Baseline questionnaires at the beginning of the experiment.
|
|
Cognitive Emotion Regulation (Strategies) - Specific
Time Frame: Baseline questionnaires at the beginning of the experiment.
|
Specific Cognitive Emotion Regulation Strategies are assessed using the german version of the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2001).
This questionnaire assesses nine dimensions of cognitive coping styles (e.g.
"other-blame") in response to distress.
It contains 36 items which can be answered on a Likert-Scale ranging from "(almost) never" (0) to "(almost) every time" (4).
Higher number indicate the higher the tendency of usage of the specific strategy and vice versa.
|
Baseline questionnaires at the beginning of the experiment.
|
|
Mindfulness Experiences
Time Frame: Baseline questionnaires at the beginning of the experiment.
|
Mindfulness Experiences is assessed using the Comprehensive Mindfulness Scale (CHIME; Bergomi, Tschacher, & Kupper, 2014).
It assesses different aspects of mindfulness experiences in daily life based on 37 items, ranging from 0 - 5. Higher number indicate the higher the awareness towards the particular experience and vice versa.
|
Baseline questionnaires at the beginning of the experiment.
|
|
Change from baseline in subject's well-being - overall
Time Frame: After 15, 20, 30, 45, and 50 minutes from baseline.
|
Overall subjective well-being is assessed by asking the participant five times "How do you feel right now?"
The subject can answer by the use of a bipolar scale (-2 "very bad", 0 "neutral", +2 "very good").
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After 15, 20, 30, 45, and 50 minutes from baseline.
|
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Change from baseline in subject's well-being - specific
Time Frame: After the mindfulness task (50 minutes) from baseline
|
Specific subjective well-being is assessed the "Mehrdimensionale Befindlichkeitsfragebogen" (MDBF; Steyer, Notz, Schwenkmezger, & Michael Eid, 1997).
This questionnaire contains 24 items and measures on three bipolar dimensions (mood, vigilance, and distress) present mental state.
Answers can be made on a Likert-Scale ranging from "absolutely not" (-2) till "very much" (+2).
The lower the number the worse the mood, or the weariness, or the distress, depending on the dimension, and vice versa.
|
After the mindfulness task (50 minutes) from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dennis Koroma, M.Sc., University of Bern, Department of Psychology
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.
Helpful Links
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 (Actual)
December 20, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
December 20, 2019
First Submitted That Met QC Criteria
April 14, 2020
First Posted (Actual)
April 17, 2020
Study Record Updates
Last Update Posted (Actual)
March 30, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EMBEX
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.
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