Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2017-11-20
2017-12-18
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Active Music Therapy
Active Music Therapy
The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
Passive Music Therapy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
Exclusion Criteria
* Cardiovascular disease
* Neurological diseases
* On medication for cardiovascular or neurological disorders
18 Years
34 Years
ALL
Yes
Sponsors
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North Carolina Translational and Clinical Sciences Institute
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Flavio Frohlich, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC Chapel Hill
Locations
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UNC Chapel Hill Medical School Wing C
Chapel Hill, North Carolina, United States
Countries
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References
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Rafieyan R, Ries R. A description of the use of music therapy in consultation-liaison psychiatry. Psychiatry (Edgmont). 2007 Jan;4(1):47-52.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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National Institute of Mental Health (2015). Major Depression Among Adults
Other Identifiers
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2KR961706
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
17-2508
Identifier Type: -
Identifier Source: org_study_id
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