Clinical trial NCT07009977: Project BrEAtHe: A Culturally Tailored MBSR Intervention for Young Adult Black Men
Official title: Project BrEAtHe: Brothers, Reclaiming Emotional Awareness Tranquility Healing & Ex-istence): Disrupting Racism-related Stress, Trauma, & Problematic Substance Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Substance Abuse
Post Traumatic Stress Disorder
Keywords: Black Men
Mindfulness-Based Stress Reduction
Substance Use
Alcohol Use
Prevention
Ecological Momentary Assessment
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: RTI International
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily Marijuana use levels
timeFrame: immediately before and after the intervention
measure: Daily Alcohol use levels
timeFrame: immediately before and after the intervention
measure: Daily Racism-Related and General Stress
timeFrame: immediately before and after the intervention
Secondary outcomes:
measure: Trauma Symptomatology
timeFrame: immediately before and after the intervention
measure: Affect Regulation (i.e., emotion suppression)
timeFrame: immediately before and after the intervention
measure: Stress Reactivity (i.e., Heart Rate Variability (HRV))
timeFrame: immediately before and after the intervention
measure: Acceptability (User Satisfaction, Intent to Continue, Perceived Appropriateness, Fit, & Demand of Use)
timeFrame: immediately after the intervention
Other outcomes:
measure: Feasibility (Recruitment, Daily Completion, & Drop-out Rates)
timeFrame: immediately after the intervention
measure: Perceptions of Delivery modalities
timeFrame: immediately after the intervention
measure: Changes in Daily Substance Use
timeFrame: Immediately after the 8-9 week intervention
measure: Changes in Daily Stress-Affective and Trauma Response
timeFrame: Immediately after the 8-9 week intervention
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
References: