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Active and Passive Music Therapy Interventions

Primary Purpose

Autonomic Nervous System Imbalance, Hypothalamic Pituitary Adrenal Axis Suppression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Music Therapy
Passive Music Therapy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autonomic Nervous System Imbalance

Eligibility Criteria

18 Years - 34 Years (Adult)All SexesAccepts 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

Sites / Locations

  • UNC Chapel Hill Medical School Wing C

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active Music Therapy

Passive Music Therapy

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 29, 2017
Last Updated
February 25, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03362944
Brief Title
Active and Passive Music Therapy Interventions
Official Title
Physiological Correlates of Active Music-making and Passive Listening in Music Based Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Nervous System Imbalance, Hypothalamic Pituitary Adrenal Axis Suppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Music Therapy
Arm Type
Experimental
Arm Title
Passive Music Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Active Music Therapy
Intervention Description
The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
Intervention Type
Behavioral
Intervention Name(s)
Passive Music Therapy
Intervention Description
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 Outcome Measure Information:
Title
Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude
Description
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.
Time Frame
Before and after 40-minute intervention
Title
Change From Baseline to Post Intervention Cortisol
Description
Stress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs.
Time Frame
Before and after 40-minute intervention
Title
Change From Baseline to Post Intervention Alpha-amylase (A-amylase)
Description
Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.
Time Frame
Before and after 40-minute intervention
Secondary Outcome Measure Information:
Title
Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude
Description
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.
Time Frame
Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.
Title
Active and Passive Music Therapy Post Intervention Cortisol
Description
Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.
Time Frame
Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
Title
Active and Passive Music Therapy Post Intervention A-amylase
Description
Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.
Time Frame
Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio Frohlich, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill Medical School Wing C
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20805929
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.
Results Reference
background
PubMed Identifier
25774137
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.
Results Reference
background
PubMed Identifier
21197136
Citation
Ellis RJ, Thayer JF. Music and Autonomic Nervous System (Dys)function. Music Percept. 2010 Apr;27(4):317-326. doi: 10.1525/mp.2010.27.4.317.
Results Reference
background
PubMed Identifier
26142566
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.
Results Reference
background
PubMed Identifier
28558878
Citation
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.
Results Reference
background
PubMed Identifier
23763714
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.
Results Reference
background
PubMed Identifier
17111118
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. doi: 10.1007/s11517-006-0119-0. Epub 2006 Nov 17.
Results Reference
background
Links:
URL
https://www.nimh.nih.gov/health/statistics/prevalence/major-depression-among-adults.shtml
Description
National Institute of Mental Health (2015). Major Depression Among Adults

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Active and Passive Music Therapy Interventions

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