DepressionAMENDNCT06924892
Assessment of Music Experiences in Navigating Depression
A study testing Music therapy and Wellness Concerts in people with Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Music therapy and Wellness Concerts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to 30 Mar 2025
- 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 8 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Music therapy, Wellness Concerts
- Keywords
- Depression, Music Assessment, Music Therapy, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Also called Music
Independent music therapy 45-minute sessions provided weekly for 3 months
Wellness ConcertsOther
Wellness Concerts provided at partner sites (Carnegie Hall Weill Music Institute, Cooper Union College, Third Street Music Settlement).
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Music therapy session for 3 months once a week Receives: Behavioral: Music therapy |
| Wellness Concerts | Other | Participants attended wellness concerts. Receives: Other: Wellness Concerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: end of study at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start5 Apr 2023
- Primary completion24 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Music therapy or no intervention provided for all consented participants
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Hall Weill Music Institute, Cooper Union, Third Street Music Settlement
- Responsible party
- Principal investigator, Joanne Loewy, Icahn School of Medicine at Mount Sinai
- Investigators
- Joanne Loewy, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924892
- Sponsor's protocol ID
- STUDY-22-01609
- Other IDs
- 1909623-38
- Acronym
- AMEND
- Status last verified
- Oct 2025
- First submitted
- 4 Apr 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Music Experiences in Navigating Depression (AMEND)
- ClinicalTrials.gov ID
- NCT06924892
- Acronym / sponsor ID
- AMEND / STUDY-22-01609
- Conditions
- Depression
- Keywords
- Depression, Music Assessment, Music Therapy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Carnegie Hall Weill Music Institute, Cooper Union, Third Street Music Settlement
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 11 Apr 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Music therapy or no intervention provided for all consented participants
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music therapyMusic therapy session for 3 months once a week |
| Wellness Concerts | Other | Other: Wellness ConcertsParticipants attended wellness concerts. |
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 therapyAlso: MusicIndependent music therapy 45-minute sessions provided weekly for 3 months | Behavioural | Music Therapy |
| Wellness ConcertsWellness Concerts provided at partner sites (Carnegie Hall Weill Music Institute, Cooper Union College, Third Street Music Settlement). | Other | Wellness Concerts |
Primary outcome
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.
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.
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.
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 20 Oct 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification.
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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.
Joanne Loewy principal investigator
Icahn School of Medicine at Mount Sinai
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 therapy and Wellness Concerts in people with Depression, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 7 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 20 Oct 2025. 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?
Connor-Davidson Resilience Scale (CD-RISC) (time frame: end of study at 3 months). 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 20 Oct 2025.