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

NCT07009977 | Terminated

• 2 other identifiers: 21-232O-1R34DA054412
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; Substance Abuse; Post Traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Daily Marijuana use levels

  Daily 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.

  immediately before and after the intervention

• Daily Alcohol use levels

  Daily 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.

  immediately before and after the intervention

• Daily Racism-Related and General Stress

  Daily 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)

  immediately before and after the intervention

Secondary Outcomes (4)

• Trauma Symptomatology

  immediately before and after the intervention

• Affect Regulation (i.e., emotion suppression)

  immediately before and after the intervention

• Stress Reactivity (i.e., Heart Rate Variability (HRV))

  immediately before and after the intervention

• Acceptability (User Satisfaction, Intent to Continue, Perceived Appropriateness, Fit, & Demand of Use)

  immediately after the intervention

Other Outcomes (4)

• Feasibility (Recruitment, Daily Completion, & Drop-out Rates)

  immediately after the intervention

• Perceptions of Delivery modalities

  immediately after the intervention

• Changes in Daily Substance Use

  Immediately after the 8-9 week intervention

Study Arms (2)

Group based MBSR training with BrEAtHe App (No Feedback)

EXPERIMENTAL

self-guided mHealth app only

Behavioral: self-guided mHealth app only

Group based MBSR training with BrEAtHe App (Feedback)

EXPERIMENTAL

self-guided mHealth app + 'real-time' feedback.

Behavioral: self-guided mHealth app + 'real-time' feedback

Interventions

self-guided mHealth app only BEHAVIORAL

Mindfulness based stress reduction

Group based MBSR training with BrEAtHe App (No Feedback)

self-guided mHealth app + 'real-time' feedback BEHAVIORAL

Mindfulness based stress reduction with mobile app feedback

Group based MBSR training with BrEAtHe App (Feedback)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead
• RTI International: collaborator
• University of North Carolina, Chapel Hill: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders; Stress Disorders, Post-Traumatic; Alcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Health Disparities Institute, Associate Professor of Psychiatry

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: June 8, 2025
• Study Start: September 27, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2025-11

Locations

US (1)