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

NCT ID: NCT06756698

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Mood Disorders in Children and Adolescents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

conventional treatment

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

conventional treatment plus music intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yue Ding

Role: CONTACT

yueding@smhc.org.cn

+86-021-34773660

Other Identifiers

2024-07

Identifier Type: -

Identifier Source: org_study_id