NOT_YET_RECRUITING
Music Mindfulness Study 2a.
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.
Conditions:
🦠 Mental Health Issue 🦠 COVID-19
🗓️ Study Start (Actual) July 2024
🗓️ Primary Completion (Estimated) July 2025
✅ Study Completion (Estimated) July 2025
👥 Enrollment (Estimated) 70
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New Haven, Connecticut, United States
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 July 2024
  • First Submitted that Met QC Criteria 16 July 2024
  • First Posted 17 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 July 2024
  • Last Update Posted 26 July 2024
  • Last Verified July 2024