Ireland
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Recruiting Not applicable

Effect of Music Therapy in Mental Subhealth (EMTMS)

NCT05648539 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-04-19
Last updated
2023-04-18

Condition(s) studied

Depression, Anxiety

Investigational drug(s) / intervention(s)

The mini apps named "SOUL GYM" on the Wechat

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' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety.

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
35 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at week 4. — Baseline and week 4.
    The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.
  • Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at week 4. — Baseline and week 4.
    The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.
  • Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4. — Baseline and week 4.
    The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.
  • Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4. — Baseline and week 4.
    The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).

Trial sites (1)

FacilityCityRegionStatus
Affiliated Nanjing Brain Hospital, Nanjing Medical University Nanjing Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05648539 on ClinicalTrials.gov ↗ ← All trials in China