N/A N=16 Randomized Treatment

Active and Passive Music Therapy Interventions

Autonomic Nervous System Imbalance · Hypothalamic Pituitary Adrenal Axis Suppression

Bottom Line

View on ClinicalTrials.gov: NCT03362944 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude — 0.1796; 0.1507; -0.3872; 0.3731 Decibels

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active Music Therapy (Behavioral); Passive Music Therapy (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude	0.1796; 0.1507; -0.3872; 0.3731	—
PRIMARY Change From Baseline to Post Intervention Cortisol	-0.0496; -0.0174	—
PRIMARY Change From Baseline to Post Intervention Alpha-amylase (A-amylase)	-19.0285; -3.9287	—
SECONDARY Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude	1826; 1220; 1.344; 1.753	—
SECONDARY Active and Passive Music Therapy Post Intervention Cortisol	.1784; .1839	—
SECONDARY Active and Passive Music Therapy Post Intervention A-amylase	75.02; 57.31	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03362944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.