Active and Passive Music Therapy Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Physiological Correlates of Active Music-making and Passive Listening in Music Based Interventions

Conditions
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Autonomic Nervous System Imbalance, Hypothalamic Pituitary Adrenal Axis Suppression

Intervention / Treatment
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* Behavioral: Active Music Therapy
* Behavioral: Passive Music Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 34 years of age Capacity to understand all relevant risks and potential benefits of the study (informed consent) Exclusion Criteria: Non-English speaker Cardiovascular disease Neurological diseases On medication for cardiovascular or neurological disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Music Therapy<br> | Behavioral: Active Music Therapy<br>* The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.<br>|
| Experimental: Passive Music Therapy<br> | Behavioral: Passive Music Therapy<br>* The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |