Study Results
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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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-08-01
2025-08-31
Brief Summary
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Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
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.
in person meditation
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.
in person meditation using headphones
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.
virtual meditation
virtually guided meditation via Zoom
Interventions
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in person meditation
in person guided meditation
in person meditation using headphones
in person meditation using headphones
virtual meditation
virtually guided meditation via Zoom
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Yale University
OTHER
Responsible Party
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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
Musical Intervention Studios
New Haven, Connecticut, United States
Countries
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Central Contacts
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Other Identifiers
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2000028866_a
Identifier Type: -
Identifier Source: org_study_id
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