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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04350515
Other study ID # EMBEX
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2019
Est. completion date December 31, 2021

Study information

Verified date March 2023
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date December 31, 2021
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Cyberball: Other Exclusion
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.
Cyberball: Player Exclusion
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.
Mindfulness: Emotion Regulation Task
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.
Mindfulness: Word Recognition Task
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.

Locations

Country Name City State
Switzerland University of Bern, Institute of Psychology Bern BE

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Points for Fairness 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.
Primary Changes in Heart Rate Variability (HRV; RMSSD) from baseline (t0) 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 Belief in a Just World 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.
Secondary Rejection Sensitivity 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.
Secondary Cognitive Emotion Regulation (Strategies) - Basic 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.
Secondary Cognitive Emotion Regulation (Strategies) - Specific 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.
Secondary Mindfulness Experiences 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.
Secondary Change from baseline in subject's well-being - overall 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"). After 15, 20, 30, 45, and 50 minutes from baseline.
Secondary Change from baseline in subject's well-being - specific 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
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