Music Mindfulness Study 2a.

NCT06505226 | Recruiting

• 2 other identifiers: 2000028866_a2R25MH071584-11
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Keywords

Mindfulness; Meditation; Music

Outcome Measures

Primary Outcomes (1)

• Mean Score Perceived Stress Scale

  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.

  8 weeks

Secondary Outcomes (1)

• Mean Score Social Connectedness Scale

  8 weeks

Study Arms (3)

In person with live music

EXPERIMENTAL

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.

Behavioral: in person meditation

In person with headphones

EXPERIMENTAL

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.

Behavioral: in person meditation using headphones

Virtual participation

EXPERIMENTAL

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.

Behavioral: virtual meditation

Interventions

in person meditation BEHAVIORAL

in person guided meditation

In person with live music

in person meditation using headphones BEHAVIORAL

in person meditation using headphones

In person with headphones

virtual meditation BEHAVIORAL

virtually guided meditation via Zoom

Virtual participation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptoms of anxiety or depression assessed by PHQ9 (\>9) and GAD7 (\>9)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

BLOOM

New Haven, Connecticut, 06515, United States

RECRUITING

Musical Intervention Studios

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• AZA Allsop, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AZA Allsop, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Screening prior to the consent process will include assessing the age and relevant medical history of each prospective participant.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)