Active and Passive Music Therapy Interventions
Condition: Autonomic Nervous System Imbalance; Hypothalamic Pituitary Adrenal Axis Suppression
MeSH terms: Pituitary Diseases
Study type: Interventional

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.
    

Intervention name(s): Active Music Therapy; Passive Music Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.; The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment