Active and Passive Music Therapy Interventions

February 25, 2019 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill Medical School Wing C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Music Therapy
Behavioral: Active Music Therapy
The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
Experimental: Passive Music Therapy
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude
Time Frame: Before and after 40-minute intervention
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
Time Frame: Before and after 40-minute intervention
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)
Time Frame: Before and after 40-minute intervention
Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.
Before and after 40-minute intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude
Time Frame: Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.
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.
Active and Passive Music Therapy Post Intervention Cortisol
Time Frame: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
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.
Active and Passive Music Therapy Post Intervention A-amylase
Time Frame: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

North Carolina Translational and Clinical Sciences Institute

Investigators

  • Principal Investigator: Flavio Frohlich, PhD, UNC Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

December 18, 2017

Study Completion (Actual)

December 18, 2017

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2508
  • 2KR961706 (Other Grant/Funding Number: NCTraCS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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