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

NCT06756698 | Active Not Recruiting

• 1 other identifier: 2024-07
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mood Disorders in Children and Adolescents

Keywords

NSSI; music therapy; children and adolescent; mood disorders; hyperscanning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• psychological scale measurement：Children's Depression Inventory (CDI)

  before and after three weeks of music intervention

• psychological scale measurement：Fear of Negative Evaluation Scale (FNE)

  before and after three weeks of music intervention

• psychological scale measurement：Emotion Regulation Questionnaire (ERQ)

  before and after three weeks of music intervention

• psychological scale measurement：Alexian Brothers Urge to Self-Injure Scale (ABUSI)

  before and after three weeks of music intervention

• psychological scale measurement：Difficulties in Emotion Regulation Scale (DERS)

  before and after three weeks of music intervention

Study Arms (2)

conventional treatment

ACTIVE COMPARATOR

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

conventional treatment plus music intervention

EXPERIMENTAL

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

Interventions

conventional treatment plus music intervention OTHER

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.

conventional treatment plus music intervention

conventional treatment OTHER

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.

conventional treatment

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 3, 2025
• Study Start: July 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)