不同类型的反刍思维的青少年非自杀性自伤患者对情绪面孔的注意偏向研究及干预

注册号:

Registration number:

ChiCTR2600122431 

最近更新日期:

Date of Last Refreshed on:

2026-04-14 08:57:34 

注册时间:

Date of Registration:

2026-04-14 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

不同类型的反刍思维的青少年非自杀性自伤患者对情绪面孔的注意偏向研究及干预

Public title:

Attentional Bias to Emotional Faces in NSSI Adolescents: The Influence of Rumination Subtypes and Intervention Strategies

注册题目简写:

English Acronym:

研究课题的正式科学名称:

不同类型的反刍思维的青少年非自杀性自伤患者对情绪面孔的注意偏向研究及干预

Scientific title:

Attentional Bias to Emotional Faces in NSSI Adolescents: The Influence of Rumination Subtypes and Intervention Strategies

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:

高静 

研究负责人:

高静 

Applicant:

Gao Jing 

Study leader:

Gao Jing 

申请注册联系人电话:

Applicant telephone:

+86 134 8874 8399

研究负责人电话:

Study leader's
telephone:

+86 134 8874 8399

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:

dy5823415@163.com

研究负责人电子邮件:

Study leader's E-mail:

dy5823415@163.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

北京回龙观医院

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:

北京市昌平区回南路7号

研究负责人通讯地址:

北京市昌平区回南路7号

Applicant address:

No. 7, Huinan Road, Changping District, Beijing

Study leader's address:

No. 7, Huinan Road, Changping District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

北京回龙观医院

Applicant's institution:

Beijing Huilongguan Hospital, Capital Medical University

研究负责人所在单位:

北京回龙观医院

Affiliation of the Leader:

Beijing Huilongguan Hospital, Capital Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2024-39-科; 2024-39-科-定1

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:

北京回龙观医院伦理委员会

Name of the ethic committee:

Ethics Committee, Beijing Huilongguan Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024-04-30 00:00:00

伦理委员会联系人:

王绍礼

Contact Name of the ethic committee:

ShaoLi Wang

伦理委员会联系地址:

北京市昌平区回南路7号

Contact Address of the ethic committee:

No. 7, Huinan Road, Changping District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 8302 4461

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:

北京回龙观医院

Primary sponsor:

Beijing Huilongguan Hospital, Capital Medical University

研究实施负责(组长)单位地址:

北京市昌平区回南路7号

Primary sponsor's address:

No. 7, Huinan Road, Changping District, Beijing

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

市(区县):

市辖区

Country:

China

Province:

Beijing

City:

单位(医院):

北京回龙观医院

具体地址:

北京市昌平区回南路7号

Institution
hospital:

Beijing Huilongguan Hospital, Capital Medical University

Address:

No. 7, Huinan Road, Changping District, Beijing

经费或物资来源:

北京市高层次公共卫生技术人才建设项目培养计划

Source(s) of funding:

Beijing High-Level Public Health Technical Talent Development Progra

研究疾病:

反刍思维的青少年非自杀性自伤  

Target disease:

Non-Suicidal Self-Injury in Adolescents with Rumination

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

随机抽样 

Study design:

Randomly Sampling 

研究目的:

对青少年非自杀性自伤患者进行正念干预,为期一个月,共 12 次的正念呼吸干预治疗,评价其干预后的反刍、情绪、注意偏向的变化。  

Objectives of Study:

Mindfulness intervention was conducted for adolescent patients with non-suicidal self-injury for one month, with a total of 12 sessions of mindfulness breathing intervention treatment. Changes in rumination, emotion and attentional bias after the intervention were evaluated.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.伴有精神病症状或意识障碍等疾病; 2.合并严重躯体疾病者; 3.现存自杀行为者(跳楼、大量吞药等); 4.严重冲动兴奋、攻击性及不配合者; 5.语言表达、理解有障碍者; 6.合并其他精神障碍。

Exclusion criteria:

1. Those with psychiatric symptoms or consciousness disorders and other diseases; 2. Those with severe physical diseases; 3. Those with existing suicidal behaviors (such as jumping off buildings or taking large amounts of medication); 4. Those with severe impulse excitement, aggression and non-cooperation; 5. Those with language expression and comprehension disorders; 6. Those with other mental disorders.

研究实施时间:

Study execute time:

From 2026-04-15 00:00:00 To 2026-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-04-15 00:00:00 To 2026-06-30 00:00:00

干预措施:

Interventions:

组别:

正念干预组

样本量:

68

Group:

Mindfulness Intervention Group

Sample size:

干预措施:

使用正念呼吸指导材料(统一培训)对患者使用指导语持续十分钟。正念干预组每周一、三、五上午完成 3 次训练,持续 4 周。

干预措施代码:

Intervention:

The mindfulness breathing guidance materials (uniform training) were used to provide instructions to the patients for a duration of ten minutes. The mindfulness intervention group completed 3 training sessions each week on Mondays, Wednesdays, and Fridays in the morning, and this lasted for 4 weeks.

Intervention code:

组别:

对照组

样本量:

68

Group:

Control Group

Sample size:

干预措施:

按常规护理,并在相应时间收集评价指标。

干预措施代码:

Intervention:

The control group received treatment as usual, and outcome measures were collected at the corresponding time points.

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 

市(区县):

市辖区 

Country:

China

Province:

Beijing

City:

单位(医院):

北京回龙观医院 

单位级别:

三甲 

Institution
hospital:

Beijing Huilongguan Hospital, Capital Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

反应时指标

指标类型:

主要指标

Outcome:

Reaction time indicators

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

青少年自我伤害行为问卷

指标类型:

次要指标

Outcome:

Adole scents self-harm scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

正念五因素量表

指标类型:

次要指标

Outcome:

Five Facet Mindfulness Questionnaire

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Barratt冲动性量表

指标类型:

次要指标

Outcome:

Barratt Impulsiveness Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

正性负性情绪量表

指标类型:

次要指标

Outcome:

Positive and Negative Affect Schedule

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 25 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):

由研究小组成员采用计算机随机数字表法将被试随机分为正念组和对照组

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

Participants were randomly assigned to the mindfulness group and the control group by research staff using a computer-generated random number table.

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:

受试者盲法 由于正念呼吸干预的特性,受试者知晓自身分组情况,故不对受试者设盲,但受试者不知晓研究的具体假设和主要结局指标,以减少期望效应。 干预实施者 正念组由经过统一培训的小组成员实施干预,对照组由常规护理人员提供护理,两组干预人员相互独立,均不参与结局评估。

Blinding:

Participant Blinding Due to the nature of mindfulness breathing intervention, participants were aware of their group assignment; therefore, participants were not blinded. However, participants were unaware of the specific study hypotheses and primary outcome measures to minimize expectation effects. Intervention Providers The mindfulness group received intervention from team members with standardized training, while the control group received routine care from nursing staff. Intervention providers in both groups were independent of each other and did not participate in outcome assessment.

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

否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):

问卷星

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

Wenjuanxing

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:

由双人核对并录入excel

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

It is double-checked and entered into Excel by two people.

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:

 2026-04-14 08:57:16