An interventional study of The mini apps named "SOUL GYM" on the Wechat in Depression, Anxiety, sponsored by Jiangsu Province Nanjing Brain Hospital. Recruiting at 1 site in China. Open to participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Jiangsu Province Nanjing Brain Hospital · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 150 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Jiangsu Province Nanjing Brain Hospital is the lead sponsor of 22 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
To assessthe efficacy of music therapy of MT group compared to Waiting group in mental subhealth.
Device: The mini apps named "SOUL GYM" on the Wechat
To understand the possible biological mechanism underlying the efficacy of music therapy by analyzing alterations of acoustic features.
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' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety.
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at 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.
Time frame: Baseline and week 4.
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at 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.
Time frame: Baseline and week 4.
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at 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.
Time frame: Baseline and week 4.
Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4.
The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).
Time frame: Baseline and week 4.
Plan to share: No
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Jiangsu Province Nanjing Brain Hospital