Problems Related to Life-Management DifficultyNCT05727514
Beyond COVID-19: Supporting Resilience With a Trauma-informed Music Composition Program
A study testing music composition in people with Problems Related to Life-Management Difficulty, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Problems Related to Life-Management Difficulty
- What is being tested?
- music composition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to 1 Feb 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 60 years of age
- Massachusetts residents
- exhibiting English fluency
- in care with an MGB provider
- admitted as an inpatient for at least 3 days to an MGB hospital between March 15, 2020 and July 21, 2022
- not hospitalized within the month before starting the study.
Who cannot join
- neuropsychiatric illness impeding participation in the study including suicidality, psychosis, active substance use, and dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Trauma-Informed Music Composition Program Supporting Resilience in Individuals Hospitalized During the COVID-19 Pandemic
This study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic.
Read the detailed description
This study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic. The pandemic introduced widespread trauma for patients facing hospitalization. Therapeutic music interventions have demonstrated positive psychological effects, but none have explored the specific trauma-informed aspects of a composition-mentor program, as well as the specific impact of music composition on resilience-related traits.
Researchers implemented an adapted version of the New York Philharmonic Very Young Composers program (VYC): trained composer-mentors guide participants through four web-based sessions to elicit and develop participants' unique musical ideas into finished compositions. Participants are then invited to view a string quartet performance of their compositions. The Brief Resilience Scale [BRS] and New General Self-Efficacy Scale [NGSE] are administered pre-intervention, post-intervention, and post-performance.
- Being tested
- music composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music compositionOther
4-session music composition program for participants lead by a composer-mentor, includes optional viewing of online string quartet performances of final musical scores
| Study group | Role | What they receive |
|---|---|---|
| enrolled participants | Other | participation in 4-session music composition program with optional viewing of performance at the end Receives: Other: music composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
New General Self-Efficacy Scale [NGSE]
The New General Self-Efficacy (NGSE) scale evaluates one's perception of their overall ability to perform successfully in a variety of common scenarios by rating each item from 1-"Strongly Disagree" to 5-"Strongly Agree". Responses were scored by averaging the ratings across items.
Min possible score: 1 Max possible score: 5
Min study score: 3.125 Max study score: 5.00
Higher scores mean a better outcome.
Measured: Data was collected at three time points over 5 months: Pre-Intervention (Baseline: upon enrollment), Post-Intervention (after the final intervention session), and Post-performance (after the final performance).
Post-musical composition program questionnaire
Four questions designed for this study elicited open-ended feedback regarding the participant experience of the program: (1) What did you enjoy about this program? (2) What did you find challenging about this program? (3) What did you learn about yourself through this program? (4) Would you recommend this program to other survivors of serious illness?
Measured: Data was collected at one time point, within one week following the final session of the music composition intervention
Post-musical performance program questionnaire
Four questions designed for this study elicited open-ended feedback regarding the participant experience of listening to their music composition performed by professional musicians: (1) What was it like to hear your composition performed by professional musicians? (2) How did participating in this performance increase the impact of this program overall? (3) Does this program make you feel more confident about being able to be creative in the future? (4) Would you recommend attending the performance as part of this program to other survivors of serious illness?
Measured: Data was collected at one time point, within two weeks following the end of the music performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start22 Apr 2021
- Primary completion30 Nov 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problems Related to Life-Management DifficultyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case series
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Berklee College of Music
- Responsible party
- Principal investigator, Nomi Levy-Carrick, MD, MPHIL, Brigham and Women's Hospital
- Investigators
- Nomi Levy-Carrick, MD, MPhil, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727514
- Sponsor's protocol ID
- 2021P000904
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trauma-Informed Music Composition Program Supporting Resilience in Individuals Hospitalized During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05727514
- Acronym / sponsor ID
- 2021P000904
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Berklee College of Music
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 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 explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic.
Detailed description
This study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic. The pandemic introduced widespread trauma for patients facing hospitalization. Therapeutic music interventions have demonstrated positive psychological effects, but none have explored the specific trauma-informed aspects of a composition-mentor program, as well as the specific impact of music composition on resilience-related traits.
Researchers implemented an adapted version of the New York Philharmonic Very Young Composers program (VYC): trained composer-mentors guide participants through four web-based sessions to elicit and develop participants' unique musical ideas into finished compositions. Participants are then invited to view a string quartet performance of their compositions. The Brief Resilience Scale [BRS] and New General Self-Efficacy Scale [NGSE] are administered pre-intervention, post-intervention, and post-performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series
| Arm | Type | Receives |
|---|---|---|
| enrolled participants | Other | Other: music compositionparticipation in 4-session music composition program with optional viewing of performance at the end |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 60 years of age
- Massachusetts residents
- exhibiting English fluency
- in care with an MGB provider
- admitted as an inpatient for at least 3 days to an MGB hospital between March 15, 2020 and July 21, 2022
Key exclusion criteria (1 listed)
- neuropsychiatric illness impeding participation in the study including suicidality, psychosis, active substance use, and dementia
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 |
|---|---|---|
| music composition4-session music composition program for participants lead by a composer-mentor, includes optional viewing of online string quartet performances of final musical scores | Other | enrolled participants |
Primary outcome
New General Self-Efficacy Scale [NGSE]
Time frame: Data was collected at three time points over 5 months: Pre-Intervention (Baseline: upon enrollment), Post-Intervention (after the final intervention session), and Post-performance (after the final performance).
The New General Self-Efficacy (NGSE) scale evaluates one's perception of their overall ability to perform successfully in a variety of common scenarios by rating each item from 1-"Strongly Disagree" to 5-"Strongly Agree". Responses were scored by averaging the ratings across items. Min possible score: 1 Max possible score: 5 Min study score: 3.125 Max study score: 5.00 Higher scores mean a better outcome.
Post-musical composition program questionnaire
Time frame: Data was collected at one time point, within one week following the final session of the music composition intervention
Four questions designed for this study elicited open-ended feedback regarding the participant experience of the program: (1) What did you enjoy about this program? (2) What did you find challenging about this program? (3) What did you learn about yourself through this program? (4) Would you recommend this program to other survivors of serious illness?
Post-musical performance program questionnaire
Time frame: Data was collected at one time point, within two weeks following the end of the music performance
Four questions designed for this study elicited open-ended feedback regarding the participant experience of listening to their music composition performed by professional musicians: (1) What was it like to hear your composition performed by professional musicians? (2) How did participating in this performance increase the impact of this program overall? (3) Does this program make you feel more confident about being able to be creative in the future? (4) Would you recommend attending the performance as part of this program to other survivors of serious illness?
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 8 Mar 2023.
- Individual participant dataSharing planned: No
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.
Nomi Levy-Carrick, MD, MPhil principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music composition in people with Problems Related to Life-Management Difficulty, run by Brigham and Women's Hospital 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 6 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 8 Mar 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?
New General Self-Efficacy Scale [NGSE] (time frame: Data was collected at three time points over 5 months: Pre-Intervention (Baseline: upon enrollment), Post-Intervention (after the final intervention session), and Post-performance (after the final performance).). The study lists 3 primary outcomes in all. 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 8 Mar 2023.