Clinical trial NCT06756698: The Intervention Effect and Potential Neural Mechanisms of Music Therapy in Children and Adolescents with Mood Disorders
Official title: The Intervention Effect and Potential Neural Mechanisms of Music Therapy in Children and Adolescents with NSSI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mood Disorders in Children and Adolescents
Keywords: NSSI
music therapy
children and adolescent
mood disorders
hyperscanning
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: psychological scale measurement：Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: before and after three weeks of music intervention
measure: psychological scale measurement：Beck Depression Inventory-II (BDI-II)
timeFrame: before and after three weeks of music intervention
measure: psychological scale measurement：Beck Scale for Suicide Ideation (BSS)
timeFrame: before and after three weeks of music intervention
Secondary outcomes:
measure: psychological scale measurement：Children's Depression Inventory (CDI)
timeFrame: before and after three weeks of music intervention
measure: psychological scale measurement：Fear of Negative Evaluation Scale (FNE)
timeFrame: before and after three weeks of music intervention
measure: psychological scale measurement：Emotion Regulation Questionnaire (ERQ)
timeFrame: before and after three weeks of music intervention
measure: psychological scale measurement：Alexian Brothers Urge to Self-Injure Scale (ABUSI)
timeFrame: before and after three weeks of music intervention
measure: psychological scale measurement：Difficulties in Emotion Regulation Scale (DERS)
timeFrame: before and after three weeks of music intervention
measure: psychological scale measurement：Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: before and after three weeks of music intervention
measure: DBT-Ways of Coping Checklist (DBT-WCCL)
timeFrame: before and after three weeks of music intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References: