General PopulationNCT04288908
Trait Injustice, Social Exclusion, and Anger
A study testing Cyberball experimental task in people with General Population, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Participants will be randomly allocated to one of two experimental conditions: social exclusion or social inclusion. Participants, but not experimenters will be blind to the assignment. Pre- and post-tests will be administered. Participants will be offered 7 euros in compensation for participating. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- General Population
- What is being tested?
- Cyberball experimental task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jan 2020to 15 Feb 2020
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being over 18 years of age
- Signs the informed consent
- Can read and understand Spanish
Who cannot join
- Being younger than 18 years of age
- Does not sign the informed consent
- Cannot read or understand Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trait Injustice and Its Effects on Anger Induced by Social Exclusion
Participants will be randomly allocated to one of two experimental conditions: social exclusion or social inclusion. Participants, but not experimenters will be blind to the assignment. Pre- and post-tests will be administered. Participants will be offered 7 euros in compensation for participating.
- Conditions
- General Population
- Being tested
- Cyberball experimental task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberball experimental taskOther
Cyberball is an experimental task in which participants have to pass a ball to two virtual players during 60 passes in total
| Study group | Role | What they receive |
|---|---|---|
| Social exclusion | Experimental | Cyberball is a ball-passing task in which the participant plays with two virtual players. In this condition, the user receives fewer passes than the other two participants (i.e., 10 out of 60). Receives: Other: Cyberball experimental task |
| Social inclusion | Active comparator | Cyberball is a ball-passing task in which the participant plays with two virtual players. In this condition, the user receives a comparable number of passes than the other two participants (i.e., 20 out of 60). Receives: Other: Cyberball experimental task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anger State from baseline to end of the experiment
The STAXI-2 includes a measure of anger state (15 items) with responses ranging from 1="Absolutely not" to 3="A lot"
Measured: The STAXI-2 will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
Trait Injustice
The Trait Injustice Experiences Questionnaire is a measure of perceived trait injustice beliefs that has 12 items, with responses ranging from 0="never" to 4="always". This measure will be used as moderator of the effects of the experiment on anger
Measured: This measure will be administered at Baseline
Secondary outcomes (4)
Frustration Discomfort Scale
This is a measure of frustration intolerance. The scale has 28 items that are gouped in 4 subscales. Items have a 1-to-5 response scale ranging from "nothing" to "a lot". In addition to trait injustice, this measure will also be used in secondary analyses as a moderator of the effects of the experiment on anger
Measured: This measure will be administered at Baseline
Change in State Injustice from baseline to end of the experiment
The State Injustice Experiences Questionnaire is a measure of perceived state injustice beliefs that has 12 items, with responses ranging from 0="never" to 4="always". This measure will be used as an experimental check (whether exclusion in the experiment effectively increased the sense of injustice in the short term)
Measured: This measure will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
Change in State Anxiety from baseline to end of the experiment
The STAI-S is a measure of perceived state anxiety that has 20 items, with responses ranging from 0="not at all" to 3="a lot". This measure will be used as an experimental check (whether exclusion in the experiment effectively increased anxiety in the short term)
Measured: This measure will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
Cyberball Experiences post-experimental check Questionnaire
In addition to exploring the effects of the experimental task on anxiety and anger, the Cyberball includes a measure of impact of the task on perceived inclusion and related concepts (isolation, belonging, perceived number of passes received, etc.). This will also be used as an experimental check
Measured: This measure will be administered at the same day of Baseline assessment just after the experimental task (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start5 Jan 2020
- Primary completion8 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General PopulationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two conditions, based on the experimental task called Cyberball, will be: social inclusion and social exclusion.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288908
- Sponsor's protocol ID
- InjusticeUJI
- Status last verified
- Jun 2020
- First submitted
- 20 Jan 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the main PI will have access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trait Injustice and Its Effects on Anger Induced by Social Exclusion
- ClinicalTrials.gov ID
- NCT04288908
- Acronym / sponsor ID
- InjusticeUJI
- Conditions
- General Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 28 Feb 2020 (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.
Participants will be randomly allocated to one of two experimental conditions: social exclusion or social inclusion. Participants, but not experimenters will be blind to the assignment. Pre- and post-tests will be administered. Participants will be offered 7 euros in compensation for participating.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The two conditions, based on the experimental task called Cyberball, will be: social inclusion and social exclusion.
| Arm | Type | Receives |
|---|---|---|
| Social exclusion | Experimental | Other: Cyberball experimental taskCyberball is a ball-passing task in which the participant plays with two virtual players. In this condition, the user receives fewer passes than the other two participants (i.e., 10 out of 60). |
| Social inclusion | Active comparator | Other: Cyberball experimental taskCyberball is a ball-passing task in which the participant plays with two virtual players. In this condition, the user receives a comparable number of passes than the other two participants (i.e., 20 out of 60). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being over 18 years of age
- Signs the informed consent
- Can read and understand Spanish
Key exclusion criteria (3 listed)
- Being younger than 18 years of age
- Does not sign the informed consent
- Cannot read or understand Spanish
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 |
|---|---|---|
| Cyberball experimental taskCyberball is an experimental task in which participants have to pass a ball to two virtual players during 60 passes in total | Other | Social exclusion, Social inclusion |
Primary outcome
Change in Anger State from baseline to end of the experiment
Time frame: The STAXI-2 will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
The STAXI-2 includes a measure of anger state (15 items) with responses ranging from 1="Absolutely not" to 3="A lot"
Trait Injustice
Time frame: This measure will be administered at Baseline
The Trait Injustice Experiences Questionnaire is a measure of perceived trait injustice beliefs that has 12 items, with responses ranging from 0="never" to 4="always". This measure will be used as moderator of the effects of the experiment on anger
4 secondary outcomes
Frustration Discomfort Scale
Time frame: This measure will be administered at Baseline
Change in State Injustice from baseline to end of the experiment
Time frame: This measure will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
Change in State Anxiety from baseline to end of the experiment
Time frame: This measure will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)
Cyberball Experiences post-experimental check Questionnaire
Time frame: This measure will be administered at the same day of Baseline assessment just after the experimental task (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Individual participant dataSharing planned: No. Only the main PI will have access to the data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyberball experimental task in people with General Population, run by Universitat Jaume I at 1 site in Spain.
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 3 inclusion and 3 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 19 Jun 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 Spain. 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?
Change in Anger State from baseline to end of the experiment (time frame: The STAXI-2 will be administered twice: at Baseline and at the same day of Baseline assessment just after the experimental task (end of study)). 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?
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 19 Jun 2020.