NCT05879809

Effect of Music Therapy in Depressive Symptoms of Mood Disorder（EMTDSMD）

Effect of Music Therapy in Depressive Symptoms of Mood Disorder: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jiangsu Province Nanjing Brain Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Depressive symptom is a common symptom that can be present in various psychiatric conditions, including depression and bipolar disorder. If left untreated, moderate to severe depressive symptoms can lead to serious health complications and are closely linked with suicide. Music therapy (MT)interventions have emerged as an important non-pharmacological approach to treating psychiatric and behavioral disorders, and have been observed to effectively alleviate depressive symptoms. Through its impact on the cerebral cortex, hypothalamus, and limbic system, music helps to regulate an individual's psychological state and can alleviate depressive symptoms. This study utilized a randomized clinical trial design involving two groups: the MT group and the control group, both of which exhibited depressive symptoms. The MT group received MT in addition to routine clinical treatment, while the control group received only routine clinical treatment. The objective of this study was to demonstrate that MT is an effective intervention for alleviating depressive symptoms and to elucidate the neurobiological mechanisms of MT.

Detailed description

This study is a double-blind randomized controlled trial aimed at evaluating the effectiveness of MT compared to a control group for major depressive disorder. Participants will be randomly assigned in a 1:1 ratio to the MT group or control group. All participants will receive 12 sessions (3 sessions per week), each lasting 30 minutes, over a 4-week period. The MT group will receive music therapy during the first 4 weeks, while the control group will receive music therapy during the subsequent 4 weeks (weeks 5-8). Prior to the start of the study (baseline) and after the 4-week intervention, both groups will undergo symptom assessments and brain imaging (MRI) to collect data. The MT intervention consists of three stages, each with a specific focus: 1) physical and mental relaxation, which involves learning relaxation techniques from breathing to muscle relaxation; 2) nature imagination, which includes guided music imagery; and 3) internal self-exploration, which involves identifying positive experiences and potential resources for psychological intervention. The study aims to: 1) assess the clinical efficacy of MT in reducing depressive symptoms, and 2) examine possible biological mechanisms underlying the effectiveness of MT through multidimensional analysis of neuroimaging data and acoustic feature alterations.

Conditions

• Mood Disorder (Depressive Episodes)

Interventions

Type	Name	Description
DEVICE	The mini apps named "SOUL GYM" on the Wechat	Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The clinical symptoms will be evaluated before and after MT intervention.
DEVICE	The mini apps named "SOUL GYM" on the Wechat	Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The acoustic features will be evaluated before and after MT intervention.
DEVICE	The mini apps named "SOUL GYM" on the Wechat	Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The neuroimaging features will be evaluated before and after MT intervention.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-01-01
• Completion: 2024-05-01
• First posted: 2023-05-30
• Last updated: 2023-05-30