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

NCT05746312 | Completed

• 1 other identifier: IRB21-0256
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• State anxiety

  Assessed with the State-Trait Anxiety Inventory - 6 \[Higher Score = More Anxiety\]

  Duration of study visit (60-90 minutes)

Study Arms (1)

Multiple-baseline study

EXPERIMENTAL

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

Interventions

healing attempt BEHAVIORAL

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.

Multiple-baseline study

Eligibility Criteria

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

You may qualify if:

• 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?")."

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Grant Jones

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 27, 2023
• Study Start: January 16, 2023
• Primary Completion: January 21, 2023
• Study Completion: January 21, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

US (1)