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Clinical Trials/NCT06756698
NCT06756698
Active, Not Recruiting
N/A

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

Shanghai Mental Health Center2 sites in 1 country54 target enrollmentJuly 31, 2024

Overview

Phase
N/A
Intervention
conventional treatment
Conditions
Mood Disorders in Children and Adolescents
Sponsor
Shanghai Mental Health Center
Enrollment
54
Locations
2
Primary Endpoint
psychological scale measurement:Screen for Child Anxiety Related Emotional Disorders (SCARED)
Status
Active, Not Recruiting
Last Updated
4 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 31, 2024
End Date
March 31, 2027
Last Updated
4 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

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.

Intervention: conventional treatment

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.

Intervention: conventional treatment plus music intervention

Outcomes

Primary Outcomes

psychological scale measurement:Screen for Child Anxiety Related Emotional Disorders (SCARED)

Time Frame: before and after three weeks of music intervention

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.

psychological scale measurement:Beck Depression Inventory-II (BDI-II)

Time Frame: before and after three weeks of music intervention

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.

psychological scale measurement:Beck Scale for Suicide Ideation (BSS)

Time Frame: before and after three weeks of music intervention

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.

Secondary Outcomes

  • 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)
  • psychological scale measurement:Center for Epidemiologic Studies Depression Scale (CES-D)(before and after three weeks of music intervention)
  • DBT-Ways of Coping Checklist (DBT-WCCL)(before and after three weeks of music intervention)

Study Sites (2)

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