Active and Passive Music Therapy Interventions

NCT03362944 | Completed Results

• 2 other identifiers: 17-25082KR961706
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Nervous System Imbalance; Hypothalamic Pituitary Adrenal Axis Suppression

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude

  Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.

• Active and Passive Music Therapy Post Intervention Cortisol

  Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.

• Active and Passive Music Therapy Post Intervention A-amylase

  Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.

Study Arms (2)

Active Music Therapy

EXPERIMENTAL

Behavioral: Active Music Therapy

Passive Music Therapy

EXPERIMENTAL

Behavioral: Passive Music Therapy

Interventions

Active Music Therapy BEHAVIORAL

The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.

Active Music Therapy

Passive Music Therapy BEHAVIORAL

The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.

Passive Music Therapy

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 34 years of age
• Capacity to understand all relevant risks and potential benefits of the study (informed consent)

You may not qualify if:

• Non-English speaker
• Cardiovascular disease
• Neurological diseases
• On medication for cardiovascular or neurological disorders

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC Chapel Hill Medical School Wing C

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (7)

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

  PMID: 20805929 BACKGROUND

• 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.

  PMID: 25774137 BACKGROUND

• 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.

  PMID: 21197136 BACKGROUND

• 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.

  PMID: 26142566 BACKGROUND

• 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.

  PMID: 28558878 BACKGROUND

• 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.

  PMID: 23763714 BACKGROUND

• 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.

  PMID: 17111118 BACKGROUND

Related Links

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

Results Point of Contact

• Title: Trevor McPherson
• Organization: Frohlich Lab - University of North Carolina at Chapel HIll

trevor_mcpherson@med.unc.edu

919-966-4755

Study Officials

• Flavio Frohlich, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: November 20, 2017
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2018-03

Locations

US (1)