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| ID | Type | Description | Link |
|---|---|---|---|
| 2KR961706 | Other Grant/Funding Number | NCTraCS |
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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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Purpose: In this preparatory study, the investigators will demonstrate the feasibility of using a structured MT intervention as a treatment for MDD by measuring stress hormone levels and HRV before and after interventions.
Participants: Participants will be healthy controls ages 18 to 34 years old, both male and female, english speakers, with no history or cardiovascular or neurological diseases.
Procedures: A passive listening control will be used in conjunction with an active music therapy intervention to assess whether the physiological correlates can be targeted by active music-making. Participants will experience both the control and the intervention in separate sessions for a within participants design. HRV and saliva samples will be recorded pre and post intervention for both sessions. The investigators anticipate that the active MT intervention will produce greater physiological changes (pre intervention to post intervention) than the passive listening control. Model-based estimation of treatment effects and components of variance will inform our choice of the sample size deemed necessary for a subsequent grant-funded MT-MDD clinical trial.
Music therapy (MT) interventions are a cost-effective, accessible, and holistic treatment option with social, rhythmic, creative, sensorimotor, and respiratory components, giving them the potential to improve the quality of life for a diverse array of disorders. Despite this, the literature surrounding MT is controversial due to the lack of standardization in clinical and research practice. Interventions range from passive listening of participant selected music to clinician lead improvisational sessions. This inhibits a mechanistic understanding of how MT functions, and what components produce therapeutic effects. Controlled studies that target physiological outcomes are vital for the development of evidence-based MT treatments.
Major depressive disorder (MDD) is a leading cause of disability for U.S. and affects more than 16 million Americans each year. Existing interventions struggle to combat this societal burden and fail to reach the large number of treatment resistant patients, creating an urgent need for the development of new treatment paradigms. Hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis and dysregulation of the autonomic nervous system (ANS) have been implicated in MDD. Listening to music has been shown to alter stress hormone levels and heart rate variability (HRV), physiological correlates of the HPA axis and ANS respectively. Active music-making's effects on these correlates has yet to be studied. Since active musical engagement involves multiple sensory inputs-proprioceptive and motor in addition to auditory-it has the potential to heighten physiological changes associated with listening to music alone. By contrasting a structured participation MT intervention with a listening control, the investigators will target the effects of active participation in music-making as a potential treatment for MDD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Music Therapy | Experimental |
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| Passive Music Therapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Music Therapy | Behavioral | The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude | Five minute heart-rate variability (HRV) recordings will be taken before and after each intervention session through two electrodes placed on the participant's right collarbone and left rib cage. The recordings will be analyzed for HF and LF/HF components, which correspond with sympathetic and parasympathetic autonomic nervous system (ANS) activity. | Before and after 40-minute intervention |
| Change From Baseline to Post Intervention Cortisol | Stress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs. | Before and after 40-minute intervention |
| Change From Baseline to Post Intervention Alpha-amylase (A-amylase) | Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs. | Before and after 40-minute intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude | Post intervention HRV recordings, assessed through two electrodes placed on the participant's right collarbone and left rib cage, will be compared between the Active and Passive intervention conditions. | Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich, PhD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill Medical School Wing C | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20805929 | Background | Rafieyan R, Ries R. A description of the use of music therapy in consultation-liaison psychiatry. Psychiatry (Edgmont). 2007 Jan;4(1):47-52. | |
| 25774137 | Background | Thaut MH, McIntosh GC, Hoemberg V. Neurobiological foundations of neurologic music therapy: rhythmic entrainment and the motor system. Front Psychol. 2015 Feb 18;5:1185. doi: 10.3389/fpsyg.2014.01185. eCollection 2014. |
| Label | URL |
|---|---|
| National Institute of Mental Health (2015). Major Depression Among Adults | View source |
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No participants were excluded from the study prior to assignment to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Music Therapy Followed by Passive Music Therapy | Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse. Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse. Interventions were spaced at minimum one week apart. |
| FG001 | Passive Music Therapy Followed by Active Music Therapy | Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse. Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse. Interventions were spaced at minimum one week apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Single Week Washout Period |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Includes all participants in both treatment arms:
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse. Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse. For each arm interventions were spaced at minimum one week apart. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude | Five minute heart-rate variability (HRV) recordings will be taken before and after each intervention session through two electrodes placed on the participant's right collarbone and left rib cage. The recordings will be analyzed for HF and LF/HF components, which correspond with sympathetic and parasympathetic autonomic nervous system (ANS) activity. | Posted | Mean | Standard Deviation | Decibels | Before and after 40-minute intervention |
|
Collection of adverse events ranged from enrollment to the completion of the second intervention. This time course was approximately 1 month for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Music Therapy | Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trevor McPherson | Frohlich Lab - University of North Carolina at Chapel HIll | 919-966-4755 | trevor_mcpherson@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2017 | Oct 29, 2018 | Prot_SAP_000.pdf |
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| Passive Music Therapy | Behavioral | The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse. |
|
| Active and Passive Music Therapy Post Intervention Cortisol | Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions. | Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame. |
| Active and Passive Music Therapy Post Intervention A-amylase | Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions. | Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame. |
| 21197136 | Background | Ellis RJ, Thayer JF. Music and Autonomic Nervous System (Dys)function. Music Percept. 2010 Apr;27(4):317-326. doi: 10.1525/mp.2010.27.4.317. |
| 26142566 | Background | Linnemann A, Ditzen B, Strahler J, Doerr JM, Nater UM. Music listening as a means of stress reduction in daily life. Psychoneuroendocrinology. 2015 Oct;60:82-90. doi: 10.1016/j.psyneuen.2015.06.008. Epub 2015 Jun 21. |
| 28558878 | Background | Dean J, Keshavan M. The neurobiology of depression: An integrated view. Asian J Psychiatr. 2017 Jun;27:101-111. doi: 10.1016/j.ajp.2017.01.025. Epub 2017 Jan 29. |
| 23763714 | Background | Mikutta CA, Schwab S, Niederhauser S, Wuermle O, Strik W, Altorfer A. Music, perceived arousal, and intensity: psychophysiological reactions to Chopin's "Tristesse". Psychophysiology. 2013 Sep;50(9):909-19. doi: 10.1111/psyp.12071. Epub 2013 Jun 14. |
| 17111118 | Background | Rajendra Acharya U, Paul Joseph K, Kannathal N, Lim CM, Suri JS. Heart rate variability: a review. Med Biol Eng Comput. 2006 Dec;44(12):1031-51. doi: 10.1007/s11517-006-0119-0. Epub 2006 Nov 17. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse. |
|
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| Primary | Change From Baseline to Post Intervention Cortisol | Stress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs. | Posted | Mean | Standard Deviation | Micrograms per deciliter | Before and after 40-minute intervention |
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|
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| Primary | Change From Baseline to Post Intervention Alpha-amylase (A-amylase) | Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs. | Posted | Mean | Standard Deviation | units per milliliter | Before and after 40-minute intervention |
|
|
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| Secondary | Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude | Post intervention HRV recordings, assessed through two electrodes placed on the participant's right collarbone and left rib cage, will be compared between the Active and Passive intervention conditions. | Posted | Mean | Standard Deviation | Decibels | Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame. |
|
|
|
| Secondary | Active and Passive Music Therapy Post Intervention Cortisol | Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions. | Posted | Mean | Standard Deviation | micrograms per deciliter | Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame. |
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|
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| Secondary | Active and Passive Music Therapy Post Intervention A-amylase | Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions. | Posted | Mean | Standard Deviation | Units per milliliter | Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame. |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Passive Music Therapy | Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse. | 0 | 16 | 0 | 16 | 0 | 16 |
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