- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06924892
Assessment of Music Experiences in Navigating Depression (AMEND)
October 15, 2025 updated by: Joanne Loewy, Icahn School of Medicine at Mount Sinai
Assessment of Music Experiences in Navigating Depression (AMEND)
The study team sought to scientifically investigate strategic subsets of depressed individuals or people prone to or at-risk of depression through music experiences of individual, group, and blended supported contexts.
Meetings with the study multi-disciplinary team, included member of the Carnegie Hall Weill Music Institute and University affiliates, where the study team gathered quantitative and qualitative data in individual and group forums, measuring disease process and levels of participation.
Through tabulation of participatory options with standardized depression and resilience measurements, the study team studied how live music could alter depressive symptoms over time and/ or change negative influencers of mood, shift quality of life, and lead toward possibly enhanced disease trajectory outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Mount Sinai Union Square
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants between the ages of 8-70 years with a clinical diagnosis of Major Depressive Disorder (MOD) who met the DSM-5 (2013) criteria for a Major Depressive Episode, and/or who identify themselves, or are identified by family, or referring clinicians as depressed, or are prone to depression
- Depressive episodes and/or showing symptoms of mild to moderate depression intensity
- Self-reported satisfactory bilateral hearing
- English or Spanish language fluency sufficient to complete the interviews and questionnaires
Exclusion Criteria:
- Axis I diagnosis, aside from MOD, considered the primary diagnosis
- Bipolar Disorder Type I or II,
- Axis II diagnosis such as antisocial or borderline.
- Arrhythmia,
- Pacemaker
- Prolapsed vertebral disc, and
- Recent back or neck injuries.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Therapy
Music therapy session for 3 months once a week
|
Independent music therapy 45-minute sessions provided weekly for 3 months
Other Names:
|
|
Other: Wellness Concerts
Participants attended wellness concerts.
|
Wellness Concerts provided at partner sites (Carnegie Hall Weill Music Institute, Cooper Union College, Third Street Music Settlement).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: end of study at 3 months
|
The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency.
The 10-item instrument has high internal consistency.
Each item consists of a 5-point Likert scale (scored from zero to four).
Ranging from 0-40 with higher scores reflecting greater perceived resilience.
|
end of study at 3 months
|
|
Child Depression Inventory
Time Frame: end of study at 3 months
|
The total score range 0 to 54 which is converted to a T-Score, higher score indicates more symptoms.
|
end of study at 3 months
|
|
The Beck Depression Inventory Second Edition (BDI-II) score
Time Frame: end of study at 3 months
|
The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression.
The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms).
The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.
|
end of study at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joanne Loewy, Icahn School of Medicine at Mount Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2023
Primary Completion (Actual)
March 24, 2025
Study Completion (Actual)
March 30, 2025
Study Registration Dates
First Submitted
April 4, 2025
First Submitted That Met QC Criteria
April 4, 2025
First Posted (Actual)
April 11, 2025
Study Record Updates
Last Update Posted (Actual)
October 20, 2025
Last Update Submitted That Met QC Criteria
October 15, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-22-01609
- 1909623-38 (Other Grant/Funding Number: National Endowment for the Arts)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
To achieve aims in the approved proposal.
Proposals should be directed to Joanne.Loewy@mountsinai.org.
To gain access, data requestors will need to sign a data access agreement.
Data are available for 5 years at a third-party website (Link included in the URL field below)
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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