CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Active Music Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03362944
NCT03362944N/ACompleted

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

University of North Carolina, Chapel Hill·interventional·Posted Dec 5, 2017·Updated Jun 5, 2019

In Brief

A clinical study evaluating Active Music Therapy and Passive Music Therapy for Autonomic Nervous System Imbalance and Hypothalamic Pituitary Adrenal Axis Suppression. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 5, 2017
Enrollment StartNov 20, 2017
Primary CompletionDec 18, 2017
TodayJul 2, 2026
Enrollment to primary: 28 daysPosted 8.6 years ago

Interventions

Active Music Therapybehavioral

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

Passive Music Therapybehavioral

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