Music Mindfulness Study 2a.
- Conditions
- COVID-19Mental Health Issue
- Interventions
- Behavioral: in person meditation using headphonesBehavioral: virtual meditationBehavioral: in person meditation
- Registration Number
- NCT06505226
- Lead Sponsor
- Yale University
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- symptoms of anxiety or depression assessed by PHQ9 (>9) and GAD7 (>9)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description In person with headphones in person meditation using 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. Virtual participation virtual meditation 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. In person with live music in person meditation 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.
- Primary Outcome Measures
Name Time Method Mean Score Perceived Stress Scale 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 Outcome Measures
Name Time Method Mean Score Social Connectedness Scale 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.
Trial Locations
- Locations (2)
BLOOM
🇺🇸New Haven, Connecticut, United States
Musical Intervention Studios
🇺🇸New Haven, Connecticut, United States