- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05727514
Beyond COVID-19: Supporting Resilience With a Trauma-informed Music Composition Program
A Trauma-Informed Music Composition Program Supporting Resilience in Individuals Hospitalized During the COVID-19 Pandemic
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (1) 18 to 60 years of age, (2) Massachusetts residents, (3) exhibiting English fluency, (4) in care with an MGB provider, (5) admitted as an inpatient for at least 3 days to an MGB hospital between March 15, 2020 and July 21, 2022, and (6) not hospitalized within the month before starting the study.
Exclusion Criteria:
- neuropsychiatric illness impeding participation in the study including suicidality, psychosis, active substance use, and dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: enrolled participants
participation in 4-session music composition program with optional viewing of performance at the end
|
4-session music composition program for participants lead by a composer-mentor, includes optional viewing of online string quartet performances of final musical scores
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
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).
|
|
Qualitative Outcomes: post-intervention and performance questions
Time Frame: Data was collected at two time points over 5 months, post-intervention and post-performance
|
Post-Intervention (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-Performance: (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? |
Data was collected at two time points over 5 months, post-intervention and post-performance
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nomi Levy-Carrick, MD, MPhil, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021P000904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.