Back to resultsMusic-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
healing attempt
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria: Familiarity with meditation Turns to music for emotional support Elevated trait anxiety (>=12 on the State Trait Anxiety Inventory - Trait [STAIT]-5) Majority of anxiety comes from racism or discrimination (>=60 on a scale of 0 [not at all] to 100 [entirely] for the following question; "If you are a racial or ethnic minority, how much do you feel that racism and/or discrimination contribute to your elevated anxiety levels?")." Exclusion Criteria: -
Sites / Locations
- Harvard University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multiple-baseline study
Arm Description
All participants in this study received the same protocol. First, we had a baseline control period (no intervention) during which we assessed state anxiety levels every two minutes. Subsequently, we administered the intervention and continued to assess state anxiety at two minute intervals. Participants were randomized to baseline periods that varied in length (10,12,14, or 16 minutes of baseline).
Outcomes
Primary Outcome Measures
State anxiety
Assessed with the State-Trait Anxiety Inventory - 6 [Higher Score = More Anxiety]
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05746312
Brief Title
Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community
Official Title
A Digital Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community: a Replication and Extension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 21, 2023 (Actual)
Study Completion Date
January 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study uses a multiple-baseline design and aims to replicate findings that a digital music-based mindfulness intervention can reduce elevated race-based state anxiety in Black Americans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We recruited 8 Black American adults to participate in this multiple baseline study. In a multiple-baseline design, one takes repeated measurements of one's outcomes of interest across time, and subsequently compares these outcomes of interest between an initial baseline control period with no intervention and a subsequent intervention period. This is a within-subjects study design for which participants serve as their own control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple-baseline study
Arm Type
Experimental
Arm Description
All participants in this study received the same protocol. First, we had a baseline control period (no intervention) during which we assessed state anxiety levels every two minutes. Subsequently, we administered the intervention and continued to assess state anxiety at two minute intervals. Participants were randomized to baseline periods that varied in length (10,12,14, or 16 minutes of baseline).
Intervention Type
Behavioral
Intervention Name(s)
healing attempt
Intervention Description
The intervention consists of pre-composed and pre-recorded guided meditations, songs, and poems that total 25 minutes in duration. The elements of the intervention were set to background music tracks that were informed by Black diasporic music traditions and anxiety reduction principles from the music therapy literature.
Primary Outcome Measure Information:
Title
State anxiety
Description
Assessed with the State-Trait Anxiety Inventory - 6 [Higher Score = More Anxiety]
Time Frame
Duration of study visit (60-90 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Familiarity with meditation
Turns to music for emotional support
Elevated trait anxiety (>=12 on the State Trait Anxiety Inventory - Trait [STAIT]-5)
Majority of anxiety comes from racism or discrimination (>=60 on a scale of 0 [not at all] to 100 [entirely] for the following question; "If you are a racial or ethnic minority, how much do you feel that racism and/or discrimination contribute to your elevated anxiety levels?")."
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Jones
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard University
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community
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