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

NCT ID: NCT07009977

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Alcohol Abuse Substance Abuse Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group based MBSR training with BrEAtHe App (No Feedback)

self-guided mHealth app only

Group Type EXPERIMENTAL

self-guided mHealth app only

Intervention Type BEHAVIORAL

Mindfulness based stress reduction

Group based MBSR training with BrEAtHe App (Feedback)

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Mindfulness based stress reduction with mobile app feedback

Interventions

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self-guided mHealth app only

Mindfulness based stress reduction

Intervention Type BEHAVIORAL

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

Mindfulness based stress reduction with mobile app feedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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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);

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Wizdom Powell

Director of Health Disparities Institute, Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Wizdom Powell, PhD

Role: CONTACT

860.679.3990

Susan Gaylord, PhD

Role: CONTACT

919.698.2745

Facility Contacts

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Susan A Gaylord, PhD

Role: primary

919-966-8586

Wizdom A Powell, PhD, MPH

Role: backup

510-289-3940

Other Identifiers

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R34DA054412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-232O-1

Identifier Type: -

Identifier Source: org_study_id

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