Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community

A Digital Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community: a Replication and Extension

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: healing attempt

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Harvard University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multiple-baseline study; 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).

Behavioral: healing attempt; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State anxiety	Assessed with the State-Trait Anxiety Inventory - 6 [Higher Score = More Anxiety]	Duration of study visit (60-90 minutes)

Collaborators and Investigators

• Sponsor: Harvard University
• Investigators: Principal Investigator: Grant Jones, Harvard University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): January 21, 2023
• Study Completion (Actual): January 21, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRB21-0256

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No