ChiCTR2400083246 版本V1.0 版本创建时间2024/04/19 08:33:51 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400083246 

最近更新日期：

Date of Last Refreshed on：

2024-04-19 08:33:46 

注册时间：

Date of Registration：

2024-04-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

个性化音乐治疗的开发及其治疗常见精神障碍的有效性、安全性与治疗机理研究

Public title：

Development, Efficacy, Safety, and Possible Mechanism of Individualized Music Therapy in Treating Common Mental Disorders

注册题目简写：

English Acronym：

研究课题的正式科学名称：

个性化音乐治疗的开发及其治疗常见精神障碍的有效性、安全性与治疗机理研究

Scientific title：

Development, Efficacy, Safety, and Possible Mechanism of Individualized Music Therapy in Treating Common Mental Disorders

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

肖春风 

研究负责人：

魏镜 

Applicant：

Xiao Chunfeng 

Study leader：

Wei Jing 

申请注册联系人电话：

Applicant telephone：

+86 176 8106 5896

研究负责人电话：

Study leader's telephone：

+86 138 0136 3383

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

springwindxiao@163.com

研究负责人电子邮件：

Study leader's E-mail：

weijing@pumch.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市东城区帅府园1号中国医学科学院北京协和医学院北京协和医院

研究负责人通讯地址：

北京市东城区帅府园1号中国医学科学院北京协和医学院北京协和医院

Applicant address：

Shuaifuyuan 1, Dongcheng District, Beijing 100730, PR China

Study leader's address：

Shuaifuyuan 1, Dongcheng District, Beijing 100730, PR China

申请注册联系人邮政编码：

Applicant postcode：

100730

研究负责人邮政编码：

Study leader's postcode：

100730

申请人所在单位：

中国医学科学院北京协和医学院北京协和医院

Applicant's institution：

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

研究负责人所在单位：

中国医学科学院北京协和医学院北京协和医院

Affiliation of the Leader：

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

I-24PJ0689

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中国医学科学院北京协和医院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of the Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-28 00:00:00

伦理委员会联系人：

李佳月

Contact Name of the ethic committee：

Li Jiayue

伦理委员会联系地址：

北京市东城区帅府园1号

Contact Address of the ethic committee：

Shuaifuyuan 1, Dongcheng District, Beijing 100730, PR China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 6915 6847

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中国医学科学院北京协和医学院北京协和医院

Primary sponsor：

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

研究实施负责（组长）单位地址：

北京市东城区帅府园1号

Primary sponsor's address：

Shuaifuyuan 1, Dongcheng District, Beijing 100730, PR China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国医学科学院北京协和医学院北京协和医院

具体地址：

北京市东城区帅府园1号

Institution
hospital：

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Address：

Shuaifuyuan 1, Dongcheng District, Beijing 100730, PR China

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China (T234100)

Target disease：

mild to moderate common mental disorders, including depression, anxiety, and insomnia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

验证个性化音乐治疗常见精神障碍（抑郁、焦虑、失眠）的有效性和安全性，并初步探索个性化音乐治疗常见精神障碍（抑郁、焦虑、失眠）的作用机制。  

Objectives of Study：

To validate the efficacy and safety of individualized music therapy for common mental disorders (depression, anxiety, insomnia) and preliminarily explore the mechanisms of action of individualized music therapy in treating these conditions.

药物成份或治疗方案详述：

本研究设计有多个子研究，各子研究采用不同的研究设计： 研究1：病例对照研究； 研究2：前瞻性队列研究； 研究3：单盲随机对照研究； 研究4：前瞻性队列研究。 详细地： 研究1:计划纳入抑郁患者、焦虑患者、失眠患者、健康对照各5人，受试者入组后接受精神心理状况评估，并接受脑电、心率变异性等生物信息采集。 研究2：计划纳入常见精神障碍患者与健康对照各20人，受试者入组后接受非个性化音乐治疗（由音乐治疗师主持的常规音乐治疗方案），在基线期、治疗后第1周末、治疗后第2周末、治疗后第4周末、治疗后第6周末和治疗后第8周末接受疗效（研究拟定的主、客观评估工具）和安全性评估。 研究3：计划纳入抑郁患者、焦虑患者、失眠患者各20人，受试者入组后1:1随机分入非个性化音乐治疗组和个性化音乐治疗组，分别接受非个性化音乐治疗和个性化音乐治疗8周，在基线期、治疗后第1周末、治疗后第2周末、治疗后第4周末、治疗后第6周末和治疗后第8周末接受疗效（研究拟定的主、客观评估工具）和安全性评估。 研究4：计划纳入抑郁患者、焦虑患者、失眠患者各15人，受试者入组后接受音乐治疗疗效预测评估，根据评估结果分为音乐治疗敏感组和音乐治疗非敏感组，2组受试者均接受一致的个性化音乐治疗，在基线期、治疗后第1周末、治疗后第2周末、治疗后第4周末、治疗后第6周末和治疗后第8周末接受疗效（研究拟定的主、客观评估工具）和安全性评估。 

Description for medicine or protocol of treatment in detail：

This research comprises several sub-studies, each utilizing a distinct research design: Study 1: Case-Control Study; Plan to enroll 5 participants each from groups of patients with depression, anxiety, insomnia, and healthy controls. After enrollment, participants will undergo psychological assessments and biological data collection including electroencephalography and heart rate variability. Study 2: Prospective Cohort Study; Plan to enroll 20 common mental disorder patients and 20 healthy controls. Participants will receive non-personalized music therapy conducted by a music therapist. Assessments of efficacy (using predefined objective and subjective tools) and safety will be conducted at baseline, and after 1, 2, 4, 6, and 8 weeks of treatment. Study 3: Single-Blind Randomized Controlled Study; Plan to enroll 20 patients each with depression, anxiety, and insomnia. Participants will be randomly assigned 1:1 to receive either non-personalized or personalized music therapy for 8 weeks. Efficacy and safety assessments will be conducted at the same intervals as in Study 2. Study 4: Prospective Cohort Study; Plan to enroll 15 patients each with depression, anxiety, and insomnia. After initial enrollment, participants will undergo an assessment to predict responsiveness to music therapy, and will be categorized into either a music therapy sensitive group or a non-sensitive group. Both groups will receive uniform personalized music therapy, with efficacy and safety assessments at the same intervals as in Study 2 and Study 3. 

纳入标准：

健康对照组： ①年龄、性别、民族与利手与患者组匹配；②基于DSM-5目前不符合任一种精神障碍的诊断标准，如抑郁障碍、双相情感障碍、精神分裂症等；③两系三代无精神障碍病史；④能够理解和配合研究程序；⑤理解并自愿参加本研究，本人签署知情同意书。 抑郁患者组： ①年龄18-60岁；②满足DSM-5轻度/中度抑郁发作诊断标准；③7分

Inclusion criteria

Health Control Group: ①Matched with the patient group in terms of age, gender, ethnicity, and handedness; ②Currently do not meet the DSM-5 diagnostic criteria for any mental disorders, such as Major Depressive Disorder, Bipolar Disorder, Schizophrenia, etc; ③No history of mental disorders within three generations of the family; ④Capable of understanding and cooperating with the study procedures; ⑤Informed and voluntarily participating in this study, with informed consent signed by the participant themselves. Depression Group: ①Aged 18-60 years; ②Meet DSM-5 criteria for mild to moderate major depressive episodes; ③Hamilton Depression Rating Scale (HAMD-17) score between 7 and 23; ④Capable of understanding and cooperating with the study procedures; ⑤Informed and voluntarily participating in this study, with informed consent signed by the participant themselves. Anxiety Group: ①Aged 18-60 years; ②Meet DSM-5 criteria for generalized anxiety disorder; ③Hamilton Anxiety Rating Scale (HAMA) score between 7 and 21; ④Capable of understanding and cooperating with the study procedures; ⑤Informed and voluntarily participating in this study, with informed consent signed by the participant themselves. Insomnia Group: ①Aged 18-60 years; ②Meet DSM-5 criteria for sleep disorders; ③With difficulty in initiating sleep as the primary symptom; ④Exhibits persistent insomnia (duration ≥ 3 months); ⑤Capable of understanding and cooperating with the study procedures; ⑥Informed and voluntarily participating in this study, with informed consent signed by the participant themselves.

排除标准：

健康对照组： ①现患影响中枢神经系统等重要器官系统结构与功能的躯体疾病；②妊娠期及哺乳期女性；③经研究者评估，存在不能配合研究过程的听力障碍；④经研究者评估，不适宜参加本研究的其他情形。 抑郁患者组： ①共病精神分裂症、双相情感障碍、焦虑障碍、强迫性障碍、进食障碍、躯体症状障碍、物质使用及行为成瘾等精神障碍；②共病影响中枢神经系统等重要器官系统结构与功能的躯体疾病；③妊娠期及哺乳期女性；④经研究者评估，存在不能配合研究过程的听力障碍。 焦虑患者组： ①共病精神分裂症、抑郁障碍、双相情感障碍、强迫性障碍、进食障碍、躯体症状障碍、物质使用及行为成瘾等精神障碍；②共病影响中枢神经系统等重要器官系统结构与功能的躯体疾病；③妊娠期及哺乳期女性；④经研究者评估，存在不能配合研究过程的听力障碍。 失眠患者组： ①共病精神分裂症、双相情感障碍、抑郁障碍、焦虑障碍、强迫性障碍、进食障碍、躯体症状障碍、物质使用及行为成瘾等精神障碍；②存在其他明确影响睡眠质量的躯体症状，如疼痛等；③共病影响中枢神经系统等重要器官系统结构与功能的躯体疾病；④妊娠期及哺乳期女性；⑤经研究者评估，存在不能配合研究过程的听力障碍。

Exclusion criteria：

Health Control Group: ①Current somatic diseases affecting the structure and function of the central nervous system or other vital organ systems; ②Women who are pregnant or breastfeeding; ③Individuals with hearing impairments that, as assessed by researchers, impede their ability to participate in the study procedures; ④Other conditions deemed by researchers as inappropriate for participation in this study. Depression Group: ①Co-morbid psychiatric disorders such as schizophrenia, bipolar disorder, anxiety disorders, obsessive-compulsive disorder, eating disorders, somatic symptom disorders, and substance use and behavioral addictions; ②Co-morbid somatic diseases affecting the structure and function of the central nervous system or other vital organ systems; ③Women who are pregnant or breastfeeding; ④Individuals with hearing impairments that, as assessed by researchers, impede their ability to participate in the study procedures. Anxiety Group: ①Co-morbid psychiatric disorders such as schizophrenia, depression, bipolar disorder, obsessive-compulsive disorder, eating disorders, somatic symptom disorders, and substance use and behavioral addictions; ②Co-morbid somatic diseases affecting the structure and function of the central nervous system or other vital organ systems; ③Women who are pregnant or breastfeeding; ④Individuals with hearing impairments that, as assessed by researchers, impede their ability to participate in the study procedures. Insomnia Group: ①Co-morbid psychiatric disorders such as schizophrenia, bipolar disorder, depression, anxiety disorders, obsessive-compulsive disorder, eating disorders, somatic symptom disorders, and substance use and behavioral addictions; ②Other clear physical symptoms affecting sleep quality, such as pain; ③Co-morbid somatic diseases affecting the structure and function of the central nervous system or other vital organ systems; ④Women who are pregnant or breastfeeding; ⑤Individuals with hearing impairments that, as assessed by researchers, impede their ability to participate in the study procedures.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-05-01 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

个性化音乐治疗组（研究3 n=30 + 研究4 n=45）

样本量：

75

Group：

individualized music therapy group (n=30 for S3 & n=45 for S4)

Sample size：

干预措施：

（根据最终形成的个性化音乐治疗方案可能会调整治疗频次）基于人工智能和脑科学监测技术的个性化音乐治疗/每晚睡前1次，每次30分钟

干预措施代码：

Intervention：

(the frequency of treatment may be adjusted according to the finalized individualized music treatment plan) individualized music therapy based on artificial intelligence and neuroscience monitoring techniques, administered once nightly before sleep, with each session lasting 30 minutes.

Intervention code：

组别：

非个性化音乐治疗组（研究2 n=40 + 研究3 n=30）

样本量：

70

Group：

music therapy as usual group (n=40 for S2 & n=30 for S3)

Sample size：

干预措施：

（根据最终形成的个性化音乐治疗方案可能会调整治疗频次）目前临床上广泛应用的传统音乐治疗/每晚睡前1次，每次30分钟

干预措施代码：

Intervention：

(the frequency of treatment may be adjusted according to the finalized individualized music treatment plan) traditional music therapy, widely used in clinical settings, administered once nightly before sleep, with each session lasting 30 minutes.

Intervention code：

组别：

健康对照组

样本量：

25

Group：

health control group

Sample size：

干预措施：

N/A

干预措施代码：

Intervention：

N/A

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中国医学科学院北京协和医学院北京协和医院 

单位级别：

三甲 

Institution
hospital：

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

蒙哥马利抑郁量表评分变化

指标类型：

主要指标

Outcome：

Change in Montgomery-Asberg Depression Rating Scale (MADRS) score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

汉密尔顿焦虑量表评分的变化

指标类型：

主要指标

Outcome：

Change in Hamilton Anxiety Scale (HAMA) score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹兹堡睡眠质量指数评分的变化

指标类型：

主要指标

Outcome：

Change in Pittsburgh Sleep Quality Index (PSQI) score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床疗效总评量表-严重程度评分的变化

指标类型：

主要指标

Outcome：

Change in Clinical Global Impression-Severity (CGI-S) score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑电图特征的变化

指标类型：

主要指标

Outcome：

Changes in electroencephalographic (EEG) characteristics

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

躁狂症状、精神病性症状、治疗相关不良反应、自杀风险、不良事件

指标类型：

副作用指标

Outcome：

manic symptoms, psychotic symptoms, adverse reactions, suicide risk, and adverse event

Type：

Adverse events

测量时间点：

测量方法：

分别采用Young氏躁狂评定量表（YMRS）、简明精神病性量表4条目阳性症状子量表（BPRS-4）、精神科药物不良反应量表（UKU）、不良反应频率和密度量表/不良反应总体负担量表（FIBSER）、哥伦比亚-自杀严重程度评定量表（C-SSRS）、不良事件采集表

Measure time point of outcome：

Measure method：

Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale 4-item positive symptom (BPRS-4), Udvalg for Kliniske Undersogelser (UKU), Frequency, Intensity, and Burden of Side Effects Rating (FIBSER), Columbia-Suicide Severity Rating Scale (C-SSRS), Adverse Event Recording Form

指标中文名：

即刻情绪评估量表评分的变化

指标类型：

附加指标

Outcome：

Changes in instant Mood Scaler (IMS) score

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

其他精神健康状况评估和一般心理社会行为信息采集

指标类型：

附加指标

Outcome：

Assessment of other mental health conditions and collection of general psychosocial and behavioral information

Type：

Additional indicator

测量时间点：

测量方法：

采用综合生理-心理-社会评估问卷（UPPSAQ-70）、防御方式问卷（DSQ）、多伦多述情障碍量表（TAS）、大五人格评估量表（BFI-2）、童年不良经历评估问卷（ACE-IQ）和生活事件量表（LES）

Measure time point of outcome：

Measure method：

Union Physio-Psycho-Social Assessment Questionnaire (UPPSAQ-70), Defense Style Questionnaire (DSQ), Toronto Alexithymia Scale (TAS), Big Five Inventory (BFI-2), Adverse Childhood Experience-International Questionnaire (ACE-IQ), Life Event Scale (LES)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由不直接参与本研究的统计师根据研究方案制定随机计划书，根据区组随机的方式使用基于Windows系统的SAS 9.4软件中PLAN步产生随机数字表。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomization plan was developed by a statistician not directly involved in this study, according to the research protocol. Random numbers were generated using the PLAN procedure in SAS 9.4 software on a Windows system, employing a block randomization method.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰地载入病例报告表。录入采用相应的数据库系统双人双机录入，之后对数据库进行两遍比对。电子数据文件分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The researchers promptly, accurately, and clearly recorded data from the original observational records of the subjects into the case report forms. The data entry was performed by a two-person team using an appropriate database system, and the database was checked twice for consistency. Electronic data files were classified and saved, with multiple backups stored on different disks or recording media, to ensure proper preservation and prevent damage.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-04-19 08:33:46