Autonomic Nervous System Imbalance, Hypothalamic Pituitary Adrenal Axis Suppression
Conditions
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.
Interventions
BEHAVIORALActive Music Therapy
The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
BEHAVIORALPassive 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.
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 34 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude | 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. |
| Change From Baseline to Post Intervention Cortisol | Before and after 40-minute intervention | 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) | Before and after 40-minute intervention | Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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. |
| 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. | Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions. |
Countries
United States
Participant flow
Pre-assignment details
No participants were excluded from the study prior to assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Includes all participants in both treatment arms:
* Active Music Therapy followed by Passive Music Therapy
* Passive Music Therapy followed by 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: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
For each arm interventions were spaced at minimum one week apart. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 16 Participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: Before and after 40-minute intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Music Therapy | Change From Baseline to Post Intervention Alpha-amylase (A-amylase) | -19.0285 units per milliliter | Standard Deviation 52.2087 |
| Passive Music Therapy | Change From Baseline to Post Intervention Alpha-amylase (A-amylase) | -3.9287 units per milliliter | Standard Deviation 32.8864 |
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.
Time frame: Before and after 40-minute intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Music Therapy | Change From Baseline to Post Intervention Cortisol | -0.0496 Micrograms per deciliter | Standard Deviation 0.0949 |
| Passive Music Therapy | Change From Baseline to Post Intervention Cortisol | -0.0174 Micrograms per deciliter | Standard Deviation 0.0558 |
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.
Time frame: Before and after 40-minute intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Music Therapy | Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude | HF power | 0.1796 Decibels | Standard Deviation 1.6943 |
| Active Music Therapy | Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude | LF/HF power | -0.3872 Decibels | Standard Deviation 0.6961 |
| Passive Music Therapy | Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude | HF power | 0.1507 Decibels | Standard Deviation 0.736 |
| Passive Music Therapy | Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude | LF/HF power | 0.3731 Decibels | Standard Deviation 0.7693 |
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.
Time frame: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Music Therapy | Active and Passive Music Therapy Post Intervention A-amylase | 75.02 Units per milliliter | Standard Deviation 62.87 |
| Passive Music Therapy | Active and Passive Music Therapy Post Intervention A-amylase | 57.31 Units per milliliter | Standard Deviation 45.31 |
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.
Time frame: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Music Therapy | Active and Passive Music Therapy Post Intervention Cortisol | .1784 micrograms per deciliter | Standard Deviation 0.0884 |
| Passive Music Therapy | Active and Passive Music Therapy Post Intervention Cortisol | .1839 micrograms per deciliter | Standard Deviation 0.0902 |
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.
Time frame: Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Music Therapy | Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude | HF power | 1826 Decibels | Standard Deviation 1723 |
| Active Music Therapy | Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude | LF/HF power | 1.344 Decibels | Standard Deviation 1.141 |
| Passive Music Therapy | Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude | HF power | 1220 Decibels | Standard Deviation 877 |
| Passive Music Therapy | Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude | LF/HF power | 1.753 Decibels | Standard Deviation 1.459 |