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

Sponsor

Harvard University (Other)

Overall Status

Completed

CT.gov ID

NCT05746312

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

48.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: healing attempt	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 16, 2023

Actual Primary Completion Date :

Jan 21, 2023

Actual Study Completion Date :

Jan 21, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard University	Cambridge	Massachusetts	United States	02138

Sponsors and Collaborators

Harvard University

Investigators

Principal Investigator: Grant Jones, Harvard University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Grant Jones, Principal Investigator, Harvard University

ClinicalTrials.gov Identifier:

NCT05746312

Other Study ID Numbers:

IRB21-0256

First Posted:

Feb 27, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Feb 27, 2023