Active and Passive Music Therapy Interventions

Not Applicable

Completed

Conditions: Autonomic Nervous System Imbalance
Hypothalamic Pituitary Adrenal Axis Suppression

Interventions: Behavioral: Passive Music Therapy
Behavioral: Active Music Therapy

Registration Number: NCT03362944

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Passive Music Therapy	Passive Music Therapy	-
Active Music Therapy	Active Music Therapy	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude	Before and after 40-minute intervention	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.
Change From Baseline to Post Intervention Cortisol	Before and after 40-minute intervention	Stress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs.
Change From Baseline to Post Intervention Alpha-amylase (A-amylase)	Before and after 40-minute intervention	Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.

Secondary Outcome Measures

Name	Time	Method
Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude	Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.	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.
Active and Passive Music Therapy Post Intervention Cortisol	Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.	Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.
Active and Passive Music Therapy Post Intervention A-amylase	Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.	Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.