Active and Passive Music Therapy Interventions

Autonomic Nervous System Imbalance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362944
• Other study ID #: 17-2508
• Secondary ID: 2KR961706
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: December 18, 2017

Study information

• Verified date: March 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Imbalance
• Hypothalamic Pituitary Adrenal Axis Suppression

Intervention

Behavioral:
• Active Music Therapy
The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
• Passive Music Therapy
The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.

Locations

Country	Name	City	State
United States	UNC Chapel Hill Medical School Wing C	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

References & Publications (7)

Dean J, Keshavan M. The neurobiology of depression: An integrated view. Asian J Psychiatr. 2017 Jun;27:101-111. doi: 10.1016/j.ajp.2017.01.025. Epub 2017 Jan 29. Review. — View Citation

Ellis RJ, Thayer JF. Music and Autonomic Nervous System (Dys)function. Music Percept. 2010 Apr;27(4):317-326. — View Citation

Linnemann A, Ditzen B, Strahler J, Doerr JM, Nater UM. Music listening as a means of stress reduction in daily life. Psychoneuroendocrinology. 2015 Oct;60:82-90. doi: 10.1016/j.psyneuen.2015.06.008. Epub 2015 Jun 21. — View Citation

Mikutta CA, Schwab S, Niederhauser S, Wuermle O, Strik W, Altorfer A. Music, perceived arousal, and intensity: psychophysiological reactions to Chopin's "Tristesse". Psychophysiology. 2013 Sep;50(9):909-19. doi: 10.1111/psyp.12071. Epub 2013 Jun 14. — View Citation

Rafieyan R, Ries R. A description of the use of music therapy in consultation-liaison psychiatry. Psychiatry (Edgmont). 2007 Jan;4(1):47-52. — View Citation

Rajendra Acharya U, Paul Joseph K, Kannathal N, Lim CM, Suri JS. Heart rate variability: a review. Med Biol Eng Comput. 2006 Dec;44(12):1031-51. Epub 2006 Nov 17. Review. — View Citation

Thaut MH, McIntosh GC, Hoemberg V. Neurobiological foundations of neurologic music therapy: rhythmic entrainment and the motor system. Front Psychol. 2015 Feb 18;5:1185. doi: 10.3389/fpsyg.2014.01185. eCollection 2014. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude	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.	Before and after 40-minute intervention
Primary	Change From Baseline to Post Intervention Cortisol	Stress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs.	Before and after 40-minute intervention
Primary	Change From Baseline to Post Intervention Alpha-amylase (A-amylase)	Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.	Before and after 40-minute intervention
Secondary	Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude	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.	Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.
Secondary	Active and Passive Music Therapy Post Intervention Cortisol	Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.	Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
Secondary	Active and Passive Music Therapy Post Intervention A-amylase	Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.	Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.

External Links

•   National Institute of Mental Health (2015). Major Depression Among Adults