The Intervention Effect and Potential Neural Mechanisms of Music Therapy in Children and Adolescents With Mood Disorders

The Intervention Effect and Potential Neural Mechanisms of Music Therapy in Children and Adolescents With NSSI

This study plans to combine questionnaires, scales, electrophysiological and neuroimaging methods to comprehensively evaluate the effectiveness of music therapy for children and adolescents with emotional disorders and NSSI, and explore the potential neural mechanisms of its effectiveness.

Study Overview

• Status: Active, not recruiting
• Conditions: Mood Disorders in Children and Adolescents
• Intervention / Treatment: Other: conventional treatment; Other: conventional treatment plus music intervention

Detailed Description

The subjects will be randomly divided into the conventional treatment group (TAU) and the music therapy group (MT). The conventional treatment group will receive DBT group therapy 5 times a week, 1 hour each time, and individual personalized therapy twice a week; the music therapy group will receive individual music therapy twice a week, 30 minutes each time, for a total of 3 weeks on top of conventional treatment.

During each intervention, near-infrared brain functional imaging, electrodermal and electrocardiographic equipment will be used to synchronously collect multimodal data from therapists and patients. The heart rate variability, electrodermal conductance response of therapists and patients, and the relative concentrations of oxygenated hemoglobin (oxy-Hb), deoxyhemoglobin (deoxy-Hb) and total hemoglobin in the brain tissue of the subjects and therapists were monitored during the treatment process.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Right-handed;
• Born and raised in China, with Chinese as the only native language;
• Voluntary participation, with the consent of the family members of patients under 18 years old, and signed the informed consent form;
• Meet the diagnostic criteria of DSM-5 anxiety disorder or depressive disorder;
• There have been two or more self-harm behaviors in the past six months.

Exclusion Criteria:

• Meet the diagnostic criteria of DSM-5 psychotic disorder, manic episode, autism spectrum disorder, mental retardation, tic disorder, substance abuse and other mental illnesses;
• Severe organic brain disease;
• Hearing loss or loss of music-related pleasure;
• Those who have clear suicidal ideation, attempt and behavior in the past month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional treatment; The conventional treatment group receives DBT group therapy 5 times a week, each time for 1 hour, and also received individual personalized therapy twice a week.	Other: conventional treatment; The conventional treatment group received DBT group therapy 5 times a week, each session lasting 1 hour, and also received individual personalized therapy twice a week.
Experimental: conventional treatment plus music intervention; The music therapy group receives individual music therapy twice a week, 30 minutes each time, for a total of 3 weeks on top of conventional treatment.	Other: conventional treatment plus music intervention; Each music therapy session will include 5 stages. In stage 1, an emotional assessment is conducted to observe the patient's current emotional experience and feelings (provide a VAD score), which lasts about 1 minute. In stage 2, relaxation exercises (breathing relaxation, progressive muscle relaxation, and imaginary relaxation) are conducted under the guidance of the therapist to the music corresponding to the relaxation target VAD, which lasts about 8 minutes. In stage 3, the patient independently selects the music and discusses it with the therapist, which lasts about 10 minutes. In stage 4, the patient listens to resource and positive-oriented music and discusses specific topics with the therapist, which lasts about 10 minutes. Finally, in stage 5, the therapist again conducts an emotional assessment of the patient and observes the patient's current emotional experience and feelings, which lasts about 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychological scale measurement：Screen for Child Anxiety Related Emotional Disorders (SCARED)	Before and after the entire music intervention course, Screen for Child Anxiety Related Emotional Disorders (SCARED) scale is administered to the subjects as baseline and final data. The minimum value is 0. The maximum value is 82. Higher scores means a worse result(the more anxious the person is). A total score of ≥ 25 may indicate the presence of an Anxiety Disorder. Scores higher than 30 are more specific.	before and after three weeks of music intervention
psychological scale measurement：Beck Depression Inventory-II (BDI-II)	Before and after the entire music intervention course, Beck Depression Inventory-II (BDI-II) scale is administered to the subjects as baseline and final data. This scale is used to assess the severity of depressive symptoms in the past two weeks, and contains 21 items, each item is scored on a level of 0~3, and the total score of the scale is the sum of the scores of 21 items. According to the cut-off score provided by the original scale such as Beck, the total score of 0~13 is no depression, 14~19 is mild depression, 20~28 is moderate depression, and 29~63 is severe depression. The minimum value is 0. The maximum value is 63. Higher scores means a worse result.	before and after three weeks of music intervention
psychological scale measurement：Beck Scale for Suicide Ideation (BSS)	Before and after the entire music intervention courseBeck Scale for Suicide Ideation (BSS) scale is administered to the subjects as baseline and final data. There are 3 options for the scale answers, and the corresponding scores from left to right are 1, 2, and 3, with the higher the score, the stronger the desire to die. All visitors complete the first 5 questions first, and if the answer to the 4th and 5th items is "no", then they are considered to have no suicidal ideation and complete this questionnaire; If any one of the 4th or 5th items is "weak" or "moderate to strong", then it is considered suicidal ideation and you need to continue to complete the next 14 items. The higher the score, the greater the intensity of suicidal ideation. Higher scores means a worse result.	before and after three weeks of music intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychological scale measurement：Children's Depression Inventory (CDI)	Before and after the entire music intervention course, Children's Depression Inventory (CDI) scale is administered to the subjects as baseline and final data. The minimum value is 0. The maximum value is 54. Higher scores means a worse result.	before and after three weeks of music intervention
psychological scale measurement：Fear of Negative Evaluation Scale (FNE)	Before and after the entire music intervention course, Fear of Negative Evaluation Scale (FNE) scale is administered to the subjects as baseline and final data. The scale is scored from 12 to 60. The opposite of a high FNE is the absence of concern about the evaluation of others, as opposed to the expectation or need for a positive evaluation.	before and after three weeks of music intervention
psychological scale measurement：Emotion Regulation Questionnaire (ERQ)	Before and after the entire music intervention course, Emotion Regulation Questionnaire (ERQ) scale is administered to the subjects as baseline and final data. The Emotion Regulation Questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression. There are 2 parts of the score, the higher of each score means the more the person use this strategy.	before and after three weeks of music intervention
psychological scale measurement：Alexian Brothers Urge to Self-Injure Scale (ABUSI)	Before and after the entire music intervention course, Alexian Brothers Urge to Self-Injure Scale (ABUSI) scale is administered to the subjects as baseline and final data. The Alexian Brothers Urge to Self-Injure Scale (ABUSI) assesses the motivation of an individual to engage in self-injury. The minimum value is 0. The maximum value is 35. Higher scores means a worse result.	before and after three weeks of music intervention
psychological scale measurement：Difficulties in Emotion Regulation Scale (DERS)	Before and after the entire music intervention course, Difficulties in Emotion Regulation Scale (DERS) scale is administered to the subjects as baseline and final data. The DERS is a brief, 36-item self-report questionnaire designed to assess multiple aspects of emotional dysregulation. The measure yields a total scorev(SUM) as well as scores on six sub-scales: 1. Non-acceptance of emotional responses (NONACCEPT); 2. Difficulties engaging in goal directed behaviour (GOALS ); 3. Impulse control difficulties (IMPULSE); 4. Lack of emotional awareness (AWARE); 5. Limited access to emotion regulation strategies (STRATEGIES); 6. Lack of emotional clarity (CLARITY). Higher scores suggest greater problems with emotion regulation.	before and after three weeks of music intervention
psychological scale measurement：Center for Epidemiologic Studies Depression Scale (CES-D)	Before and after the entire music intervention course, Center for Epidemiologic Studies Depression Scale (CES-D) scale is administered to the subjects as baseline and final data. The minimum value is 0. The maximum value is 20. Higher scores means a worse result. The total score of ≤15 points is no depressive symptoms, 16~19 points are possible depressive symptoms, and ≥ 20 points are definitely depressive symptoms.	before and after three weeks of music intervention
DBT-Ways of Coping Checklist (DBT-WCCL)	The Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) was designed to assess participants' use of DBT skills (e.g., acceptance, cognitive reappraisal, problem-solving) and maladaptive coping responses (e.g., avoidance, denial, self-blame). This is a 59-item self-report scale where participants rate their use of the scale with a four-point scale, resulting in two subscales: a DBT Skills Subscale (DSS) and a Dysfunctional Coping Subscale (DCS). The scoring is the average of relevant items for each subscale. The score for the skills use scale is the average of these items: 1, 2, 4, 6, 9, 10, 11, 13, 16, 18, 19, 21, 22, 23, 26, 27, 29, 31, 33, 34, 35,36, 38, 39, 40, 42, 43, 44, 47,49, 50, 51, 53, 54, 56, 57, 58,59 The dysfunctional coping scale 1 (general dysfunctional coping factor) has these items: 3,5, 8, 12, 14,17, 20, 25, 32, 37, 41, 45, 46,52, 55 and the dysfunctional coping scale 2 (blaming others factor) has these items: 7,15, 24, 28, 30,48	before and after three weeks of music intervention

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: music therapy; mood disorders; children and adolescent; NSSI; hyperscanning
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: 2024-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the restrictions outlined in the participants' informed consent, data are available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No