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Alcohol AbuseBrEAtHeNCT07009977

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

A study testing self-guided mHealth app only and self-guided mHealth app + 'real-time' feedback in people with Alcohol Abuse and Substance Abuse, run by UConn Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 29 years, men onlyHealthy volunteers can take part
What is being tested?
self-guided mHealth app only and self-guided mHealth app + 'real-time' feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
27 Sep 2023to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 29 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

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

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

Read the 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.

Being tested
self-guided mHealth app only, self-guided mHealth app + 'real-time' feedback
Keywords
Black Men, Mindfulness-Based Stress Reduction, Substance Use, Alcohol Use, Prevention, Ecological Momentary Assessment
Medical subject headings
Alcoholism, Substance-Related Disorders, Stress Disorders, Post-Traumatic, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • self-guided mHealth app onlyBehavioural

    Mindfulness based stress reduction

  • self-guided mHealth app + 'real-time' feedbackBehavioural

    Mindfulness based stress reduction with mobile app feedback

Study groups in NCT07009977
Study groupRoleWhat they receive
Group based MBSR training with BrEAtHe App (No Feedback)Experimentalself-guided mHealth app only
Receives: Behavioral: self-guided mHealth app only
Group based MBSR training with BrEAtHe App (Feedback)Experimentalself-guided mHealth app + 'real-time' feedback.
Receives: Behavioral: self-guided mHealth app + 'real-time' feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: immediately before and after the intervention

  2. 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.

    Measured: immediately before and after the intervention

  3. 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)

    Measured: immediately before and after the intervention

Secondary outcomes (4)

  1. Trauma Symptomatology

    Trauma 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.

    Measured: immediately before and after the intervention

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

    Investigators 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.

    Measured: immediately before and after the intervention

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

    Heart 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.

    Measured: immediately before and after the intervention

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

    Acceptability 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).

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start27 Sep 2023
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Why it stopped: Phase 1 of the clinical trial completed (Delphi Panel adaptation of the MBSR trial curriculum and MBSR mhealth app development). Too few participants enrolled into the intervention (Phase 2) to continue.

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07009977
Sponsor's protocol ID
21-232O-1
Other IDs
R34DA054412
Acronym
BrEAtHe
Status last verified
Nov 2025
First submitted
16 Feb 2024
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing self-guided mHealth app only and self-guided mHealth app + 'real-time' feedback in people with Alcohol Abuse and Substance Abuse, run by UConn Health 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Jan 2026. 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?

The study was stopped early (reason given: Phase 1 of the clinical trial completed (Delphi Panel adaptation of the MBSR trial curriculum and MBSR mhealth app development). Too few participants enrolled into the intervention (Phase 2) to continue.). Results are not available in the source record.

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?

Daily Marijuana use levels (time frame: immediately before and after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07009977.

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 26 Jan 2026.

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