Recruiting

Music Mindfulness

Sponsor:

Yale University

Code:

NCT06505226

Conditions

Mental Health Issue

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

in person meditation

in person meditation using headphones

virtual meditation

Study Details

Brief summary:

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 ID

NCT06505226

Start date

Aug 1, 2024

Status verified date

Feb, 2026

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: In person with live music

Cohort 1 will be guided through in-person meditation. Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.

experimental: In person with headphones

Cohort 2 (also in-person) will experience this same meditation as Cohort 1 concurrently through headphones (in a space separate from Cohort 1). Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.

experimental: Virtual participation

Cohort 3 will be participating virtually by following along to the guided meditation via a password-protected Zoom room. Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.

Interventions

in person meditation

in person guided meditation

in person meditation using headphones

in person meditation using headphones

virtual meditation

virtually guided meditation via Zoom

Primary outcome measure

  • Mean Score Perceived Stress Scale [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

AZA Allsop, MD, PhD

240-422-3289Aza.allsop@yale.edu

Locations

BLOOM

Recruiting

New Haven, Connecticut, United States, 06515

Musical Intervention Studios

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Mindfulness
  • Meditation
  • Music

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Yale University on 2026-02-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.