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Project BrEAtHe: A Culturally Tailored MBSR Intervention for Young Adult Black Men

Project BrEAtHe: Brothers, Reclaiming Emotional Awareness Tranquility Healing & Ex-istence): Disrupting Racism-related Stress, Trauma, & Problematic Substance Use

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07009977
Acronym
BrEAtHe
Enrollment
22
Registered
2025-06-08
Start date
2023-09-27
Completion date
2025-06-30
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Post Traumatic Stress Disorder, Substance Abuse

Keywords

Black Men, Mindfulness-Based Stress Reduction, Substance Use, Alcohol Use, Prevention, Ecological Momentary Assessment

Brief summary

The purpose of this study is to create a program focused on mindfulness and stress reduction specifically tailored to young adult Black males.

Detailed description

Project Brothers reclaiming Emotional Awareness, tranquility, Healing, and Ex-istence (BrEAtHe) is a research study to create a program focused on mindfulness and stress reduction specifically tailored to young adult Black males (18 to 29 years old) residing in Durham, NC and in Hartford, CT. The investigators plan to use a mobile app on a cell phone to better understand 'real-time' feedback of experiences of stress due to racism. The investigators are interested in learning about the recruitment and retention of Black males participating in mindfulness based practices. The investigators are also interested in receiving feedback about options to modify and scale a Mindfulness Based Stress Reduction intervention and its preliminary effects on reducing physical and emotional stress reactions and poor coping mechanisms like marijuana and alcohol use linked to everyday racism and discrimination.

Interventions

BEHAVIORALself-guided mHealth app only

Mindfulness based stress reduction

BEHAVIORALself-guided mHealth app + 'real-time' feedback

Mindfulness based stress reduction with mobile app feedback

Sponsors

UConn Health
Lead SponsorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
RTI International
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* Age: 18-29 * Ethnicity: non-Hispanic Black * Gender: Male * does not meet the DSM-V criteria for substance use disorder or dependence or severe post-traumatic stress disorder (PTSD); * Neighborhood Inclusion Criteria: must live in a high VAOD neighborhood in Durham County, NC, or North Hartford Promise Zone, CT and have resided in the selected neighborhood for at least 6 months.

Exclusion criteria

* non-English speakers, * meet the DSM-V criteria for substance use disorder or dependence or severe post-traumatic stress disorder (PTSD); * women; * men of other racial/ethnic groups; * neighborhood outside of high VAOD neighborhood in Durham County, NC or North Hartford Promise Zone, CT.

Design outcomes

Primary

MeasureTime frameDescription
Daily Marijuana use levelsimmediately before and after the interventionDaily marijuana use will be assessed with ecological momentary assessment (EMA). Participants will be asked to respond to random digital prompts on a handheld mobile device about recent substance use. Questions will include "Within the past hour, have you: (used marijuana)?" The response anchors for these questions will be "NO" or "YES." To classify alcohol or marijuana use confirmed with a "YES" response as problematic, The Drug Abuse Screening Test (DAST-10) will be administered. A separate summed score will be created for alcohol and marijuana use levels based on DSM-V criteria with higher scores indicating more problematic alcohol or marijuana use.
Daily Alcohol use levelsimmediately before and after the interventionDaily alcohol use will be assessed with ecological momentary assessment (EMA). Participants will be asked to respond to random digital prompts on a handheld mobile device about recent alcohol use (drank alcohol)?" The response anchors for these questions will be "NO" or "YES." To classify alcohol or marijuana use confirmed with a "YES" response as problematic, The Alcohol Use Disorders Identification Test (AUDIT-C) will be administered. A separate summed score will be created for alcohol and marijuana use levels based on DSM-V criteria with higher scores indicating more problematic alcohol or marijuana use.
Daily Racism-Related and General Stressimmediately before and after the interventionDaily racism-related and general stress will be assessed with questions about asked the occurrence and impact of stress related to general experiences (i.e., had money troubles; argued with spouse or partner; had transportation problems) and those attributed to experiences of everyday racism (i.e., been followed by police officers or neighborhood security patrols because of your race). The response anchors for these questions will be "NO" or "YES." The impact of these experiences will be rated on a 5-point scale (1=not at all to 5=very stressful). Higher scores on these measures indicate more frequent and impactful stress experiences. Participants will also be asked to initiate an entry when they experience an impactful everyday racism or general stress experience at times not coinciding with Random Digital Prompts or RDPs (also called event-contingent entries)

Secondary

MeasureTime frameDescription
Trauma Symptomatologyimmediately before and after the interventionTrauma symptomatology will be assessed with items from a shortened, 7-item version of the Civilian Version of the Post-Traumatic Stress Disorder Checklist for the Diagnostic Statistical Manual 5 or (PCL-5). This scale uses a dichotomous scoring scheme of 1 "yes" or 0 "no" for each item. Higher scores will indicate the presence of higher trauma symptomatology.
Affect Regulation (i.e., emotion suppression)immediately before and after the interventionInvestigators will assess affect regulation using the 10-item Emotion Regulation Questionnaire (ERQ) continuous measure assesses individual differences in the habitual use of emotion suppression and cognitive reappraisal. Consistent with previous EMA research, participants will be asked to indicate their affect regulation strategies (emotion suppression vs. reappraisal) for experiences they rate as highly stressful (3 or more rating) by responding to questions derived from the ERQ described above, "Try to remember how you responded to your feelings about this experience; Did you keep your feelings about the experience to yourself, or try to think about your feelings and the experience in a different way?" Higher scores indicate a higher participant use of and reliance on emotion suppression.
Stress Reactivity (i.e., Heart Rate Variability (HRV))immediately before and after the interventionHeart Rate Variability (HRV) will be assessed with a Faros monitor, which captures ECG at a 1000 Hz sampling frequency. A mechanism will be set on this device to assure synchrony between physiological and behavioral data. HRV monitoring will be conducted on Day 1 and post intervention for 15 minutes each.
Acceptability (User Satisfaction, Intent to Continue, Perceived Appropriateness, Fit, & Demand of Use)immediately after the interventionAcceptability will be assessed with quantitative survey measures (user satisfaction, intent to continue, perceived appropriateness, fit within disadvantaged neighborhood settings and among young adult Black males, and demand or use of BrEAtHe intervention strategies and app).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026