Music Mindfulness Study 2a.

Yale University

Status: Enrolling

Conditions: COVID-19; Mental Health Issue

Treatments: Behavioral: virtual meditation; Behavioral: in person meditation using headphones; Behavioral: in person meditation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06505226

2000028866_a

2R25MH071584-11 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

In person with live music

Experimental group

Description:

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.

Treatment:

Behavioral: in person meditation

In person with headphones

Experimental group

Description:

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.

Treatment:

Behavioral: in person meditation using headphones

Virtual participation

Experimental group

Description:

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.

Treatment:

Behavioral: virtual meditation