Clinical trial NCT05648539: Effect of Music Therapy in Mental Subhealth (EMTMS)
Official title: Effect of Music Therapy in Mental Subhealth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Keywords: Music Therapy
Depression, Anxiety
Acoustic features
Lead sponsor: Jiangsu Province Nanjing Brain Hospital
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mental health is increasingly at the forefront of concerns, especially since the start of COVID-19 pandemic. However, not all individuals under mental subhealth need pharmaceutical treatment. Music Therapy (MT) can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety.

This study adopted randomized clinical trials design, with two groups of MT group and Waiting group both under mental subhealth. The MT group received music therapy and routine activities, while the Waiting group received music therapy after the therapy of MT group. Data collections were performed by trained, certified, and qualified personnel. The study aims to provide that MT is an effective intervention way to alleviate the mental subhealth state in the future.

Detailed description: This study is a double-blind randomized controlled trial aiming at assessing the efficacy of MT compared to Waiting group in mental subhealth. Participants will be assigned randomly (1:1) to MT group and Waiting group. All the participants will be treated with 12 sessions (3 sessions per week), 30 minutes each time, and conducted for 4 weeks. The MT group received music therapy between 1st-4th week, and the Waiting group received music therapy between 5th-8th week. Pre-MT (baseline) and post-MT (4th week), two group performed symptom assessment and voice data collection (poetry readings). The MT is mainly divided into three stages, and each stage has a topic. The topic of each stage as follow: ① physical and mental relaxation stage: learning the whole body and mind relaxation mode from breathing to muscle; ② nature imagination stage: guiding music imagination; ③ internal self-exploration: excavating the positive experience and positive potential of the listener and adopting resource orientation for psychological intervention. The purposes of the present study are to: 1) evaluate the clinical response the MT in mental subhealth. 2) further understand the possible biological mechanism underlying the efficacy of MT by analyzing alterations of acoustic features.

Eligibility criteria: Inclusion Criteria:

A total of \> 5 on PHQ-9 or a total of \> 5 on GAD-7

Exclusion Criteria:

Acute suicidal thoughts, With a severe or potentially confounding psychiatric disorder (e.g. psychosis, substance misuse).

Primary outcomes:
measure: Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at week 4.
timeFrame: Baseline and week 4.
measure: Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at week 4.
timeFrame: Baseline and week 4.
measure: Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4.
timeFrame: Baseline and week 4.
measure: Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4.
timeFrame: Baseline and week 4.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Nanjing Brain Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Affiliated Nanjing Brain Hospital, Nanjing Medical University
name: Fei Wang
role: STUDY_CHAIR
References: