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Active and Passive Music Therapy Interventions

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Autonomic Nervous System Imbalance
Hypothalamic Pituitary Adrenal Axis Suppression

Treatments

Behavioral: Passive Music Therapy
Behavioral: Active Music Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03362944
17-2508
2KR961706 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 34 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Active Music Therapy
Experimental group
Treatment:
Behavioral: Active Music Therapy
Passive Music Therapy
Experimental group
Treatment:
Behavioral: Passive Music Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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