Mood Disorders in Children and AdolescentsNCT06756698
The Intervention Effect and Potential Neural Mechanisms of Music Therapy in Children and Adolescents With Mood Disorders
A study testing conventional treatment plus music intervention and conventional treatment in people with Mood Disorders in Children and Adolescents, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Mood Disorders in Children and Adolescents
- What is being tested?
- conventional treatment plus music intervention and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- conventional treatment plus music intervention, conventional treatment
- Keywords
- NSSI, music therapy, children and adolescent, mood disorders, hyperscanning
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional treatment plus music interventionOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: conventional treatment plus music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: before and after three weeks of music intervention
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: before and after three weeks of music intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start31 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood Disorders in Children and AdolescentsStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756698
- Sponsor's protocol ID
- 2024-07
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the restrictions outlined in the participants' informed consent, data are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intervention Effect and Potential Neural Mechanisms of Music Therapy in Children and Adolescents With NSSI
- ClinicalTrials.gov ID
- NCT06756698
- Acronym / sponsor ID
- 2024-07
- Keywords
- NSSI, music therapy, children and adolescent, mood disorders, hyperscanning
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Active comparator | Other: conventional treatmentThe 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. |
| conventional treatment plus music intervention | Experimental | Other: conventional treatment plus music interventionThe 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional treatment plus music interventionEach 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. | Other | conventional treatment plus music intervention |
| conventional treatmentThe 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. | Other | conventional treatment |
Primary outcome
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.
7 secondary outcomes
psychological scale measurement：Children's Depression Inventory (CDI)
Time frame: before and after three weeks of music intervention
psychological scale measurement：Fear of Negative Evaluation Scale (FNE)
Time frame: before and after three weeks of music intervention
psychological scale measurement：Emotion Regulation Questionnaire (ERQ)
Time frame: before and after three weeks of music intervention
psychological scale measurement：Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Time frame: before and after three weeks of music intervention
psychological scale measurement：Difficulties in Emotion Regulation Scale (DERS)
Time frame: before and after three weeks of music intervention
psychological scale measurement：Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: before and after three weeks of music intervention
DBT-Ways of Coping Checklist (DBT-WCCL)
Time frame: before and after three weeks of music intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. Due to the restrictions outlined in the participants' informed consent, data are available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional treatment plus music intervention and conventional treatment in people with Mood Disorders in Children and Adolescents, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological scale measurement：Screen for Child Anxiety Related Emotional Disorders (SCARED) (time frame: before and after three weeks of music intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.