AnxietyNCT05746312
Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community
A study testing healing attempt in people with Anxiety, run by Harvard University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- healing attempt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 21 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?")."
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety
- Being tested
- healing attempt
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healing attemptBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: healing attempt |
What is being measured
The primary outcome is the main question the study is designed to answer.
State anxiety
Assessed with the State-Trait Anxiety Inventory - 6 [Higher Score = More Anxiety]
Measured: Duration of study visit (60-90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start16 Jan 2023
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant Jones, Harvard University
- Investigators
- Grant Jones, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746312
- Sponsor's protocol ID
- IRB21-0256
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community: a Replication and Extension
- ClinicalTrials.gov ID
- NCT05746312
- Acronym / sponsor ID
- IRB21-0256
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multiple-baseline study | Experimental | Behavioral: healing attemptAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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?")."
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healing attemptThe 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. | Behavioural | Multiple-baseline study |
Primary outcome
State anxiety
Time frame: Duration of study visit (60-90 minutes)
Assessed with the State-Trait Anxiety Inventory - 6 [Higher Score = More Anxiety]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
Related trials for Anxiety
Recruiting
Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students
Anxiety, Depression
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Jones principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healing attempt in people with Anxiety, run by Harvard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State anxiety (time frame: Duration of study visit (60-90 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.