Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34DA054412 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| RTI International | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to create a program focused on mindfulness and stress reduction specifically tailored to young adult Black males.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group based MBSR training with BrEAtHe App (No Feedback) | Experimental | self-guided mHealth app only |
|
| Group based MBSR training with BrEAtHe App (Feedback) | Experimental | self-guided mHealth app + 'real-time' feedback. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-guided mHealth app only | Behavioral | Mindfulness based stress reduction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately before and after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Recruitment, Daily Completion, & Drop-out Rates) | Feasibility will be assessed by examining logged days of training derived from attendance records and app usage (the number of participant-initiated and app-initiated practices). | immediately after the intervention |
| Perceptions of Delivery modalities |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| self-guided mHealth app + 'real-time' feedback | Behavioral | Mindfulness based stress reduction with mobile app feedback |
|
| immediately before and after the intervention |
| 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. | immediately before and after the intervention |
| 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. | immediately before and after the intervention |
| 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). | immediately after the intervention |
Post-intervention questionnaires will be used to gather insights about young adult Black men's intervention participation experiences and perceptions of the delivery modalities. |
| immediately after the intervention |
| Changes in Daily Substance Use | Investigators will explore whether participation in the mindfulness based intervention led to reductions in daily non-problematic and problematic usage of alcohol or marijuana as determined by criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). A separate summed score will be created from dichotomous responses ("YES" or "NO") to questions about the frequency and impact of daily alcohol and marijuana use with higher scores indicating more frequent and problematic alcohol or marijuana use. | Immediately after the 8-9 week intervention |
| Changes in Daily Stress-Affective and Trauma Response | Investigators will explore whether the intervention led to reductions in intermediary stress, trauma symptomatology, emotion regulation, and Heart Rate Variability (HRV). Investigators will examine changes between baseline and post-intervention scores on the PCL-5 (trauma symptomatology), ERQ (emotion regulation), and HRV assessments (Faros monitoring). | Immediately after the 8-9 week intervention |
| D000068099 | Trauma and Stressor Related Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |