Music Mindfulness Study 2a.

NCT ID: NCT06505226

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mental Health Issue COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Screening prior to the consent process will include assessing the age and relevant medical history of each prospective participant.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

in person meditation

Intervention Type BEHAVIORAL

in person guided meditation

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.

Group Type EXPERIMENTAL

in person meditation using headphones

Intervention Type BEHAVIORAL

in person meditation using headphones

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.

Group Type EXPERIMENTAL

virtual meditation

Intervention Type BEHAVIORAL

virtually guided meditation via Zoom

Interventions

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in person meditation

in person guided meditation

Intervention Type BEHAVIORAL

in person meditation using headphones

in person meditation using headphones

Intervention Type BEHAVIORAL

virtual meditation

virtually guided meditation via Zoom

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AZA Allsop, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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BLOOM

New Haven, Connecticut, United States

Site Status RECRUITING

Musical Intervention Studios

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AZA Allsop, MD, PhD

Role: CONTACT

240-422-3289

Other Identifiers

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2R25MH071584-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000028866_a

Identifier Type: -

Identifier Source: org_study_id

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