Clinical trial NCT03362944: Active and Passive Music Therapy Interventions
Official title: Physiological Correlates of Active Music-making and Passive Listening in Music Based Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Imbalance
Hypothalamic Pituitary Adrenal Axis Suppression
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2017-12-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude
timeFrame: Before and after 40-minute intervention
measure: Change From Baseline to Post Intervention Cortisol
timeFrame: Before and after 40-minute intervention
measure: Change From Baseline to Post Intervention Alpha-amylase (A-amylase)
timeFrame: Before and after 40-minute intervention
Secondary outcomes:
measure: Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude
timeFrame: Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.
measure: Active and Passive Music Therapy Post Intervention Cortisol
timeFrame: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
measure: Active and Passive Music Therapy Post Intervention A-amylase
timeFrame: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Medical School Wing C
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Flavio Frohlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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