Behavior, SocialNCT03974282
Brain Function and Decision-Making
A study testing Psychological task in people with Behavior, Social and Psychology, Social, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is about how brain function and structure is different between two universities. Participant in this project will contribute to a better understanding of how universities affect the brain. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Social, Psychology, Social, Social Interaction
- What is being tested?
- Psychological task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergraduate students aged 18 - 35 years of age
- No current or regular use of prescribed or illicit psychoactive drugs
- Free of major health problems (e.g., diabetes, HIV, Parkinson's disease)
- Free of a neurological or psychiatric disorders
- No current drug abuse (e.g., recreational drug use, average alcohol intake in excess of 4 drinks per day).
- Right hand dominant
Show all 11Show fewer
- Free of claustrophobia
- Free of pregnancy or suspected pregnancy
- Absent MRI risk factors (e.g., implanted medical device, body mass index > 35, braces)
- Free of medical conditions that render individuals with overly sensitive hearing
- No colorblindness
Who cannot join
- Not meeting the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This study is about how brain function and structure is different between two universities. Participant in this project will contribute to a better understanding of how universities affect the brain.
Read the detailed description
Some study details are purposely omitted at this time to preserve scientific integrity. Now that the study is completed, full details are included below.
The true purpose of this study was to investigate the psychometric properties of the two computer tasks that participants completed. Specifically, researchers wanted to know if they would be able to accurately measure motivated empathy. To better understand this, participants were asked to rate images of people expressing pain and were told that these were either students from their university or students from a different university. This was not the case. The faces shown were random images produced for a research study.
Researchers also wanted to know if they could accurately measure moral decision making and how those judgments relate to aggression. To examine this, participants were asked whether various scenarios were immoral and then asked about aggressive tendencies.
- Being tested
- Psychological task
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological taskBehavioural
Participants will complete a psychological task that evokes antisocially- and prosocially-motivated empathic responding
| Study group | Role | What they receive |
|---|---|---|
| Low psychopathy distribution | Other | Participants who score at the low end of the psychopathy distribution Receives: Behavioral: Psychological task |
| High psychopathy distribution | Other | Participants who score at the high end of the psychopathy distribution Receives: Behavioral: Psychological task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prefrontal Cortex Brain Activity Assessed by fMRI
Blood-Oxygen-Level-Dependent signal change in the cognitive empathy brain network will be assessed using functional MRI
Measured: Baseline to 3 hours
Change in Accuracy of Empathic Pain Judgments
Difference in pain judgment scores rated from 1 (low) to 4 (high) between antisocial vs prosocial empathy trials
Measured: Baseline to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start20 Jun 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Behavior, SocialStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- David Chester, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974282
- Sponsor's protocol ID
- HM20015724
- Other IDs
- UL1TR002649
- Status last verified
- Feb 2023
- First submitted
- 31 May 2019
- Last updated
- 6 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Function and Decision-Making
- ClinicalTrials.gov ID
- NCT03974282
- Acronym / sponsor ID
- HM20015724
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 6 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is about how brain function and structure is different between two universities. Participant in this project will contribute to a better understanding of how universities affect the brain.
Detailed description
Some study details are purposely omitted at this time to preserve scientific integrity. Now that the study is completed, full details are included below.
The true purpose of this study was to investigate the psychometric properties of the two computer tasks that participants completed. Specifically, researchers wanted to know if they would be able to accurately measure motivated empathy. To better understand this, participants were asked to rate images of people expressing pain and were told that these were either students from their university or students from a different university. This was not the case. The faces shown were random images produced for a research study.
Researchers also wanted to know if they could accurately measure moral decision making and how those judgments relate to aggression. To examine this, participants were asked whether various scenarios were immoral and then asked about aggressive tendencies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low psychopathy distribution | Other | Behavioral: Psychological taskParticipants who score at the low end of the psychopathy distribution |
| High psychopathy distribution | Other | Behavioral: Psychological taskParticipants who score at the high end of the psychopathy distribution |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Undergraduate students aged 18 - 35 years of age
- No current or regular use of prescribed or illicit psychoactive drugs
- Free of major health problems (e.g., diabetes, HIV, Parkinson's disease)
- Free of a neurological or psychiatric disorders
- No current drug abuse (e.g., recreational drug use, average alcohol intake in excess of 4 drinks per day).
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria listed above.
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 |
|---|---|---|
| Psychological taskParticipants will complete a psychological task that evokes antisocially- and prosocially-motivated empathic responding | Behavioural | High psychopathy distribution, Low psychopathy distribution |
Primary outcome
Change in Prefrontal Cortex Brain Activity Assessed by fMRI
Time frame: Baseline to 3 hours
Blood-Oxygen-Level-Dependent signal change in the cognitive empathy brain network will be assessed using functional MRI
Change in Accuracy of Empathic Pain Judgments
Time frame: Baseline to 3 hours
Difference in pain judgment scores rated from 1 (low) to 4 (high) between antisocial vs prosocial empathy trials
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David Chester, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological task in people with Behavior, Social and Psychology, Social, run by Virginia Commonwealth University at 1 site in United States.
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 11 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 6 Feb 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Prefrontal Cortex Brain Activity Assessed by fMRI (time frame: Baseline to 3 hours). 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 6 Feb 2023.