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临床试验/NCT03362944
NCT03362944已完成不适用

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

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Active Music Therapy

Experimental

干预措施: Active Music Therapy (Behavioral)

Passive Music Therapy

Experimental

干预措施: Passive Music Therapy (Behavioral)

结局指标

主要结局

Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude

时间窗: 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

时间窗: 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)

时间窗: Before and after 40-minute intervention

Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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