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NCT Number: NCT06505226

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.

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Key information

Conditions

Mental Health Issue COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BLOOM, New Haven, Connecticut, United States

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About this study

Investigators hypothesize that this intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.

Participants will be screened, consented, and enrolled into either a 2-week pilot study (to test the feasibility of the experiment) or an 8-week full length study. The focus of this registration is the 8-week full length study.

Upon completion of the study, participants will be asked to take part in a focus group that will provide valuable feedback on their experience with the mindfulness intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

in person meditation

Behavioral

in person guided meditation

in person meditation using headphones

Behavioral

in person meditation using headphones

virtual meditation

Behavioral

virtually guided meditation via Zoom

Primary outcomes

  1. Mean Score Perceived Stress Scale

    Time frame: 8 weeks

    The Perceived Stress Scale (PSS-10) is a 10-item, validated, self-report, questionnaire used to assess perceived control and confidence in managing stressful situations over the past month. Scores range from 0 to 40, with higher scores indicated higher levels of perceived stress.

Secondary outcomes

  1. Mean Score Social Connectedness Scale

    Time frame: 8 weeks

    The Social Connectedness Scale (SCS) is a self-report questionnaire that measures the extent to which individuals feel connected to others in their social environment. 20 items on a 6-point Likert scale, from 1 (strongly disagree) to 6 (strongly agree). Total score is achieved by summing all items with total score range from 20-120. Higher scores indicate a greater sense of social connectedness.

Study contacts

Contact information is provided by the study sponsor or research team.

AZA Allsop, MD, PhD

CONTACT

[email protected]

240-422-3289

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Music Mindfulness Study 2a.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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