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AzTrials

Emotional StressEMBEXNCT04350515

Effects of Social Exclusion in The Context of Chronic Embitterment

A study testing Cyberball: Other Exclusion, Cyberball: Player Exclusion and Mindfulness: Emotion Regulation Task in people with Emotional Stress and Embitterment, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Emotional Stress, Embitterment
What is being tested?
Cyberball: Other Exclusion, Cyberball: Player Exclusion and Mindfulness: Emotion Regulation Task
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteSwitzerland
Study dates
20 Dec 2019to 31 Dec 2021
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Bern, Institute of Psychology

    Bern, Canton of Bern, 3012

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
Cyberball: Other Exclusion, Cyberball: Player Exclusion, Mindfulness: Emotion Regulation Task, Mindfulness: Word Recognition Task
Medical subject headings
Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyberball: Other ExclusionOther

    Also called In terms of outcome measure 'points for fairness': intervention condition, In terms of outcome measure 'changes in HRV': control condition

    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 ExclusionOther

    Also called In terms of outcome measure 'points for fairness': control condition, In terms of outcome measure 'changes in HRV': intervention condition

    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 TaskOther

    Also called Intervention Condition

    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 TaskOther

    Also called Control Condition

    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.

Study groups in NCT04350515
Study groupRoleWhat they receive
Cyberball: Other ExclusionExperimentalCyberball Paradigm - the avatar will be excluded by the player
Receives: Other: Cyberball: Other Exclusion; Other: Mindfulness: Emotion Regulation Task; Other: Mindfulness: Word Recognition Task
Cyberball: Player ExclusionExperimentalCyberball Paradigm - the player will be excluded by the other players
Receives: Other: Cyberball: Player Exclusion; Other: Mindfulness: Emotion Regulation Task; Other: Mindfulness: Word Recognition Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After the second Cyberball intervention (exclusion of the subject or the avatar), at approx. 30 minutes from baseline.

  2. 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).

    Measured: After approx. 15, 20, 25, 30, 35, 40, 45, and 50 minutes from baseline.

Secondary outcomes (7)

  1. 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.

    Measured: Baseline questionnaires at the beginning of the experiment.

  2. 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.

    Measured: Baseline questionnaires at the beginning of the experiment.

  3. 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.

    Measured: Baseline questionnaires at the beginning of the experiment.

  4. 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.

    Measured: Baseline questionnaires at the beginning of the experiment.

  5. 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.

    Measured: Baseline questionnaires at the beginning of the experiment.

  6. 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").

    Measured: After 15, 20, 30, 45, and 50 minutes from baseline.

  7. 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.

    Measured: After the mindfulness task (50 minutes) from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2020
  2. Study start20 Dec 2019
  3. Primary completion30 Jun 2020
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04350515
Sponsor's protocol ID
EMBEX
Acronym
EMBEX
Status last verified
Mar 2023
First submitted
20 Dec 2019
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Cyberball: Other Exclusion, Cyberball: Player Exclusion and Mindfulness: Emotion Regulation Task in people with Emotional Stress and Embitterment, run by University of Bern at 1 site in Switzerland.

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 2 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: finished, as of the sponsor's last update on 30 Mar 2023. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Points for Fairness (time frame: After the second Cyberball intervention (exclusion of the subject or the avatar), at approx. 30 minutes from baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04350515.

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 30 Mar 2023.

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