NCT05727514

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

February 8, 2023

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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?

    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?

    Data was collected at one time point, within two weeks following the end of the music performance

Study Arms (1)

enrolled participants

OTHER

participation in 4-session music composition program with optional viewing of performance at the end

Other: music composition

Interventions

4-session music composition program for participants lead by a composer-mentor, includes optional viewing of online string quartet performances of final musical scores

enrolled participants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • neuropsychiatric illness impeding participation in the study including suicidality, psychosis, active substance use, and dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Nomi Levy-Carrick, MD, MPhil

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
participants identity was not disclosed during the program
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist; Vice Chair, Clinical Program, Dept Psychiatry

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 14, 2023

Study Start

April 22, 2021

Primary Completion

November 30, 2022

Study Completion

February 1, 2023

Last Updated

March 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations