Community-based music mindfulness program for stress management in African Americans
Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Music Mindfulness Study 2a.
NA · Yale University · NCT06505226
This study is testing a music mindfulness program to see if it can help African Americans manage stress and anxiety during COVID-19.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06505226 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a virtual, community-based music mindfulness program aimed at reducing stress in People of African Descent (PADs) experiencing anxiety and depression during COVID-19. Participants will be enrolled in either a 2-week pilot or an 8-week full-length program, where they will engage in various forms of meditation, including in-person and virtual sessions. The study aims to gather data on the program's feasibility and its impact on stress management, with a focus on culturally relevant approaches. Participants will also provide feedback through focus groups after completing the program.
Who should consider this trial
Good fit: Ideal candidates are People of African Descent experiencing symptoms of anxiety or depression.
Not a fit: Patients with a history of regular meditation practice or those with severe mental health issues such as suicidal ideation or psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide a culturally relevant method for managing stress and improving mental health outcomes in marginalized communities.
How similar studies have performed: While mindfulness and music interventions have shown promise in other populations, this specific approach targeting PADs is novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * symptoms of anxiety or depression assessed by PHQ9 (\>9) and GAD7 (\>9) Exclusion Criteria: * Component 2a * PHQ-9 \<9, GAD7 \< 9 * regular meditation practice of at least once a week * has taken meditation course or intervention in the past year * any hospitalizations in the last 6 months * suicidal ideation, self-injurious behavior, or homicidal ideation at screening * active audio-visual hallucinations or other signs of psychosis * diagnosis of a seizure disorder or other neurological disorder that precludes outpatient participation * history of thyroid or cardiovascular disease * current substance use disorder
Where this trial is running
New Haven, Connecticut and 1 other locations
- BLOOM — New Haven, Connecticut, United States (RECRUITING)
- Musical Intervention Studios — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: AZA Allsop, MD, PhD — Yale University
- Study coordinator: AZA Allsop, MD, PhD
- Email: Aza.allsop@yale.edu
- Phone: 240-422-3289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mental Health Issue, COVID-19, Mindfulness, Meditation, Music