Threat SensitivityREDNCT07016945
Reactions to Distress (RED) In Louisville, KY Study
A study testing Stress and Mindfulness Intervention in people with Threat Sensitivity, run by University of Louisville at 1 site in United States.
Trial summary
The goal of this study is to understand whether race-related stress can impact the way people direct their attention and what interventions may be helpful for attention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Threat Sensitivity
- What is being tested?
- Stress and Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Eligibility for this study will include a positive response to the following questions: 1) Do you identify as Black or African American? 2) Have you ever in your lifetime personally experienced or witnessed another person experience any acts of racism or racial microaggressions? 3) Are you willing to complete a 1.5-hour study at the University of Louisville in the next 2 weeks? 4) Are you 18 or older?
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Davidson Hall
Louisville, Kentucky, 40208
Yara Mekawi, PhD, 630-863-6375, yara.mekawi@louisville.edu
About this study
Official title: Reactions to Experiencing Distress (RED) Study
The goal of this study is to understand whether race-related stress can impact the way people direct their attention and what interventions may be helpful for attention.
Read the detailed description
Race-related stress is a public health problem and a known predictor of severe psychological symptoms in Black Americans. Although there is a strong link between race-related stress and adverse mental health outcomes, limited research has examined the transdiagnostic mechanisms that explain how experiencing race-related stress contributes to psychological symptoms or what interventions might effectively target these mechanisms. The scientific premise of this study is that race-related stress may contribute to disproportionate allocation of attention toward threatening stimuli (i.e., attention bias to threat), a known predictor of stress-related symptoms. This attentional bias may be modifiable through a brief, culturally-informed mindfulness intervention.
Racial identity is hypothesized to be a key individual difference factor that influences the extent to which race-related stress affects attention bias to threat, as well as the degree to which a mindfulness intervention can mitigate these biases. The study will recruit 200 Black adults from the community who have experienced race-related stress to participate in a laboratory study targeting three specific aims:
To use eye-tracking methods to examine whether race-related stress (compared to non-race-related stress) leads to greater attention bias to threat;
To test whether a brief mindfulness meditation (compared to a neutral audio condition) reduces attention bias to threat;
To investigate whether racial identity moderates (a) the effect of the race-related stress manipulation on attention bias to threat and (b) the efficacy of the mindfulness intervention in reducing attention bias to threat.
This project includes a strong undergraduate training component designed to promote student engagement in psychological research and provide hands-on experience and comprehensive mentorship to support future research careers.
This research addresses critical gaps in the literature by investigating how race-related stress influences threat-related attentional processes, evaluating whether these processes can be altered by mindfulness-based strategies, and identifying for whom such interventions are most effective. The study utilizes a novel manipulation of race-related stress, an objective and theoretically grounded psychological mechanism (attention bias), precise assessment tools (eye-tracking), and an experimentally manipulated intervention (mindfulness), thereby addressing key limitations in existing research. Findings are expected to advance understanding of the psychological effects of racism and inform strategies to reduce mental health disparities among historically marginalized and underserved populations.
- Conditions
- Threat Sensitivity
- Being tested
- Stress and Mindfulness Intervention
- Keywords
- attention bias, mindfulness, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress and Mindfulness InterventionBehavioural
Participants will be randomized to either the race-related stress condition or the non-race-related stress condition and the experimental group (7-minute pre-recorded audio file of a guided mindfulness practice) or the control group (7-minute pre-recorded neutral audio file). Thus there are four conditions total (RRS/Control Audio, RRS/Mindfulness Audio, Control Stress/Control Audio, Control Stress/Mindfulness Audio)
| Study group | Role | What they receive |
|---|---|---|
| Main sample | Experimental | Participants are randomized to experimental and intervention conditions. They are either in: race stress/mindfulness, race stress/control audio, control stress/mindfulness, or control stress/control audio. Receives: Behavioral: Stress and Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free viewing task
Free Viewing Task. This is the outcome measure for both manipulations listed above. To assess attention bias to threat, we will use a free-viewing task in which participants are instructed to freely view a pair of images side by side across two blocks of 60 trials each. In Block 1, participants will view two types of image pairs: one threatening (i.e., angry face) and one neutral (i.e., neutral facial expression) or both neutral.
Measured: 10 minutes
Affect
To ensure that the manipulations outlined above are having the intended effect (increase in NA/ decrease in PA after stress manipulation and the opposite after the mindfulness manipulation), participants will complete the 20-item PANAS after each manipulation. The items ask participants to indicate how they are feeling in the moment in terms of both negative affect (e.g., distressed, interested) and positive affect (e.g., strong, inspired) on a scale of 1 (very slightly or not at all) to 5 (very much). Scores are summed to create a total negative affect and positive affect score.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start25 Jul 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threat SensitivityStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016945
- Sponsor's protocol ID
- iRIS234741
- Acronym
- RED
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All relevant data are regularly uploaded to NIH NDA system.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactions to Experiencing Distress (RED) Study
- ClinicalTrials.gov ID
- NCT07016945
- Acronym / sponsor ID
- RED / iRIS234741
- Conditions
- Threat Sensitivity
- Keywords
- attention bias, mindfulness, stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 Jun 2025 (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.
The goal of this study is to understand whether race-related stress can impact the way people direct their attention and what interventions may be helpful for attention.
Detailed description
Race-related stress is a public health problem and a known predictor of severe psychological symptoms in Black Americans. Although there is a strong link between race-related stress and adverse mental health outcomes, limited research has examined the transdiagnostic mechanisms that explain how experiencing race-related stress contributes to psychological symptoms or what interventions might effectively target these mechanisms. The scientific premise of this study is that race-related stress may contribute to disproportionate allocation of attention toward threatening stimuli (i.e., attention bias to threat), a known predictor of stress-related symptoms. This attentional bias may be modifiable through a brief, culturally-informed mindfulness intervention.
Racial identity is hypothesized to be a key individual difference factor that influences the extent to which race-related stress affects attention bias to threat, as well as the degree to which a mindfulness intervention can mitigate these biases. The study will recruit 200 Black adults from the community who have experienced race-related stress to participate in a laboratory study targeting three specific aims:
To use eye-tracking methods to examine whether race-related stress (compared to non-race-related stress) leads to greater attention bias to threat;
To test whether a brief mindfulness meditation (compared to a neutral audio condition) reduces attention bias to threat;
To investigate whether racial identity moderates (a) the effect of the race-related stress manipulation on attention bias to threat and (b) the efficacy of the mindfulness intervention in reducing attention bias to threat.
This project includes a strong undergraduate training component designed to promote student engagement in psychological research and provide hands-on experience and comprehensive mentorship to support future research careers.
This research addresses critical gaps in the literature by investigating how race-related stress influences threat-related attentional processes, evaluating whether these processes can be altered by mindfulness-based strategies, and identifying for whom such interventions are most effective. The study utilizes a novel manipulation of race-related stress, an objective and theoretically grounded psychological mechanism (attention bias), precise assessment tools (eye-tracking), and an experimentally manipulated intervention (mindfulness), thereby addressing key limitations in existing research. Findings are expected to advance understanding of the psychological effects of racism and inform strategies to reduce mental health disparities among historically marginalized and underserved populations.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main sample | Experimental | Behavioral: Stress and Mindfulness InterventionParticipants are randomized to experimental and intervention conditions. They are either in: race stress/mindfulness, race stress/control audio, control stress/mindfulness, or control stress/control audio. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligibility for this study will include a positive response to the following questions: 1) Do you identify as Black or African American? 2) Have you ever in your lifetime personally experienced or witnessed another person experience any acts of racism or racial microaggressions? 3) Are you willing to complete a 1.5-hour study at the University of Louisville in the next 2 weeks? 4) Are you 18 or older?
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Stress and Mindfulness InterventionParticipants will be randomized to either the race-related stress condition or the non-race-related stress condition and the experimental group (7-minute pre-recorded audio file of a guided mindfulness practice) or the control group (7-minute pre-recorded neutral audio file). Thus there are four conditions total (RRS/Control Audio, RRS/Mindfulness Audio, Control Stress/Control Audio, Control Stress/Mindfulness Audio) | Behavioural | Main sample |
Primary outcome
Free viewing task
Time frame: 10 minutes
Free Viewing Task. This is the outcome measure for both manipulations listed above. To assess attention bias to threat, we will use a free-viewing task in which participants are instructed to freely view a pair of images side by side across two blocks of 60 trials each. In Block 1, participants will view two types of image pairs: one threatening (i.e., angry face) and one neutral (i.e., neutral facial expression) or both neutral.
Affect
Time frame: 5 minutes
To ensure that the manipulations outlined above are having the intended effect (increase in NA/ decrease in PA after stress manipulation and the opposite after the mindfulness manipulation), participants will complete the 20-item PANAS after each manipulation. The items ask participants to indicate how they are feeling in the moment in terms of both negative affect (e.g., distressed, interested) and positive affect (e.g., strong, inspired) on a scale of 1 (very slightly or not at all) to 5 (very much). Scores are summed to create a total negative affect and positive affect score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No. All relevant data are regularly uploaded to NIH NDA system.
Related trials for Threat Sensitivity
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingPhase 4
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
Depression, Anxiety, Fear
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress and Mindfulness Intervention in people with Threat Sensitivity, run by University of Louisville 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 1 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara Mekawi, PhD (16308636375, yara.mekawi@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free viewing task (time frame: 10 minutes). 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 12 Jun 2025.