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Completed

NCT Number: NCT03362944

Active and Passive Music Therapy Interventions

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.

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Key information

Conditions

Autonomic Nervous System Imbalance Hypothalamic Pituitary Adrenal Axis Suppression

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill Medical School Wing C

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active music therapy

Behavioral

The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.

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.

Primary outcomes

  1. Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude

    Time frame: 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.

  2. Change From Baseline to Post Intervention Cortisol

    Time frame: Before and after 40-minute intervention

    Stress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs.

  3. Change From Baseline to Post Intervention Alpha-amylase (A-amylase)

    Time frame: Before and after 40-minute intervention

    Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.

Secondary outcomes

  1. Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude

    Time frame: 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.

  2. Active and Passive Music Therapy Post Intervention Cortisol

    Time frame: 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.

  3. Active and Passive Music Therapy Post Intervention A-amylase

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2017
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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