Assessment of Music Experiences in Navigating Depression

NCT06924892 | Completed DMC

• 2 other identifiers: STUDY-22-016091909623-38
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Music Assessment; Music Therapy; Anxiety

Outcome Measures

Primary Outcomes (3)

• Connor-Davidson Resilience Scale (CD-RISC)

  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

• The Beck Depression Inventory Second Edition (BDI-II) score

  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

• Child Depression Inventory

  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

Study Arms (2)

Music Therapy

EXPERIMENTAL

Music therapy session for 3 months once a week

Behavioral: Music therapy

Wellness Concerts

OTHER

Participants attended wellness concerts.

Other: Wellness Concerts

Interventions

Music therapy BEHAVIORAL

Independent music therapy 45-minute sessions provided weekly for 3 months

Also known as: Music

Music Therapy

Wellness Concerts OTHER

Wellness Concerts provided at partner sites (Carnegie Hall Weill Music Institute, Cooper Union College, Third Street Music Settlement).

Wellness Concerts

Eligibility Criteria

• Age: 8 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Carnegie Hall Weill Music Institute: collaborator
• Cooper Union College: collaborator
• Third Street Music Settlement: collaborator

Study Sites (1)

Mount Sinai Union Square

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joanne Loewy

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants were provided options for various music study inclusions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Director

Model Details: Music therapy or no intervention provided for all consented participants

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: April 5, 2023
• Primary Completion: March 24, 2025
• Study Completion: March 30, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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)

Locations

US (1)