早期不良经历影响快感缺失的神经心理机制:基于多模态纵向研究

注册号:

Registration number:

ChiCTR2600120275 

最近更新日期:

Date of Last Refreshed on:

2026-03-11 15:44:03 

注册时间:

Date of Registration:

2026-03-11 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

早期不良经历影响快感缺失的神经心理机制:基于多模态纵向研究

Public title:

Neuropsychological Mechanisms of Early Life Adversity on Anhedonia: A Multimodal Longitudinal Study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

早期不良经历影响快感缺失的神经心理机制:基于多模态纵向研究

Scientific title:

Neuropsychological Mechanisms of Early Life Adversity on Anhedonia: A Multimodal Longitudinal Study

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:

曹冰 

研究负责人:

曹冰 

Applicant:

Bing Cao 

Study leader:

Bing Cao 

申请注册联系人电话:

Applicant telephone:

+86 157 0239 6119

研究负责人电话:

Study leader's
telephone:

+86 157 0239 6119

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:

bingcao@swu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

bingcao@swu.edu.cn

申请单位网址(自愿提供):

Applicant website(voluntary supply):

西南大学心理学部

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:

中国重庆市北碚区天生路2号

研究负责人通讯地址:

中国重庆市北碚区天生路2号

Applicant address:

No. 2 Tiansheng Road, Beibei District, Chongqing, China

Study leader's address:

No. 2 Tiansheng Road, Beibei District, Chongqing, China

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:

西南大学心理学部

Applicant's institution:

Faculty of Psychology, Southwest University

研究负责人所在单位:

西南大学心理学部

Affiliation of the Leader:

Faculty of Psychology, Southwest 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:

SWU-ECHR-20250287

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:

西南大学人类实验(不含生命医学)伦理委员会

Name of the ethic committee:

The Human Research Ethics Committee, Southwest University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-11-20 00:00:00

伦理委员会联系人:

杨娟

Contact Name of the ethic committee:

Juan Yang

伦理委员会联系地址:

中国重庆市北碚区天生路2号

Contact Address of the ethic committee:

No. 2 Tiansheng Road, Beibei District, Chongqing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 136 3781 4760

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:

西南大学

Primary sponsor:

Southwest University

研究实施负责(组长)单位地址:

中国重庆市北碚区天生路2号

Primary sponsor's address:

No. 2 Tiansheng Road, Beibei District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

西南大学心理学部

具体地址:

中国重庆市北碚区天生路2号

Institution
hospital:

Faculty of Psychology, Southwest University

Address:

No. 2 Tiansheng Road, Beibei District, Chongqing, 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

研究疾病:

快感缺失  

Target disease:

Anhedonia

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:

探索性研究/预试验 

Study phase:

0

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

本研究旨在系统揭示早期不良经历影响快感缺失的多层次机制,并探索经颅直流电刺激(tDCS)干预对高快感缺失个体的影响,为早期干预与临床实践提供理论依据。  

Objectives of Study:

This study aims to systematically elucidate the multi-level mechanisms through which early-life adversity influences anhedonia, and to explore the effects of transcranial direct current stimulation (tDCS) intervention on individuals with high levels of anhedonia, thereby providing a theoretical basis for early intervention and clinical practice.

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.明确诊断为双相障碍、精神分裂症、自闭症谱系障碍或其他精神疾病者; 2.有重大躯体疾病、一级亲属精神疾病家族史、器质性脑损伤、物质依赖以及EEG禁忌症等的个体; 3.有神经系统疾病或病史(如癫痫、脑卒中、脑部外伤史等)的个体。

Exclusion criteria:

1. had a confirmed diagnosis of bipolar disorder, schizophrenia, autism spectrum disorder, or other psychiatric disorders; 2. had significant physical illnesses, a family history of psychiatric disorders among first‑degree relatives, organic brain injury, substance dependence, contraindications for EEG; 3. a history of neurological diseases (e.g., epilepsy, stroke, traumatic brain injury).

研究实施时间:

Study execute time:

From 2025-11-25 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-11-25 00:00:00 To 2026-12-31 00:00:00

干预措施:

Interventions:

组别:

背外侧前额叶皮层(dlPFC)干预组

样本量:

40

Group:

Dorsolateral prefrontal cortex (dlPFC) intervention group

Sample size:

干预措施:

2mA对左侧背外侧前额叶皮层(dlPFC)进行阳极刺激,总共进行10次干预,连续10日,每日一次,每次刺激20min,升温时间30s,降温时间30s,共21min。

干预措施代码:

Intervention:

Anodal stimulation was administered to the left dorsolateral prefrontal cortex (dlPFC) at 2mA. A total of 10 sessions were administered, once daily for 10 consecutive days. Each session consisted of 20min of stimulation, with 30s ramp up and 30s ramp down periods, resulting in a total duration of 21min per session.

Intervention code:

组别:

背内侧前额叶皮层(dmPFC)干预组

样本量:

40

Group:

Dorsomedial prefrontal cortex (dmPFC) intervention group.

Sample size:

干预措施:

2mA对背内侧前额叶皮层(dmPFC)进行阳极刺激,总共进行10次干预,连续10日,每日一次,每次刺激20min,升温时间30s,降温时间30s,共21min。

干预措施代码:

Intervention:

Anodal stimulation was applied to the dorsomedial prefrontal cortex (dmPFC) at 2mA. A total of 10 sessions were administered, once daily for 10 consecutive days. Each session consisted of 20min of stimulation, with 30s ramp up and 30s ramp down periods, resulting in a total duration of 21min per session.

Intervention code:

组别:

伪刺激组

样本量:

40

Group:

Sham stimulation group

Sample size:

干预措施:

伪刺激组使用的方案与干预组的方案相同,只是模拟电流在前30s缓慢增加至2mA,并在后30s降至基线。

干预措施代码:

Intervention:

The sham stimulation group followed the same protocol as the intervention groups, except that the simulated current was gradually increased to 2mA during the initial 30s and returned to the baseline level over the final 30s.

Intervention code:

组别:

高快感缺失组

样本量:

40

Group:

High anhedonia group

Sample size:

干预措施:

佩戴脑电设备完成社会奖赏加工任务与社会情绪调节任务。

干预措施代码:

Intervention:

Wearing EEG equipment, participants completed a social reward processing task and a social emotion regulation task.

Intervention code:

组别:

低快感缺失组

样本量:

40

Group:

Low anhedonia group

Sample size:

干预措施:

佩戴脑电设备完成社会奖赏加工任务与社会情绪调节任务。

干预措施代码:

Intervention:

Wearing EEG equipment, participants completed a social reward processing task and a social emotion regulation task.

Intervention code:

组别:

问卷调查组

样本量:

500

Group:

Questionnaire Survey Group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

重庆 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

西南大学心理学部 

单位级别:

大学 

Institution
hospital:

Faculty of Psychology, Southwest University

Level of the institution:

University

国家:

中国

省(直辖市):

重庆 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆三峡医药高等专科学校 

单位级别:

专科学院 

Institution
hospital:

Chongqing Three Gorges Medical College

Level of the institution:

College

测量指标:

Outcomes:

指标中文名:

P300波

指标类型:

主要指标

Outcome:

P300 Wave

Type:

Primary indicator

测量时间点:

经颅直流电刺激干预前后24小时内

测量方法:

EEG

Measure time point of outcome:

Within 24 hours before and after transcranial direct current stimulation intervention.

Measure method:

EEG

指标中文名:

关联性负变

指标类型:

主要指标

Outcome:

Contingent Negative Variation, CNV

Type:

Primary indicator

测量时间点:

经颅直流电刺激干预前后24小时内

测量方法:

Measure time point of outcome:

Within 24 hours before and after transcranial direct current stimulation intervention.

Measure method:

指标中文名:

早期后部负波

指标类型:

主要指标

Outcome:

Early Posterior Negativity, EPN

Type:

Primary indicator

测量时间点:

经颅直流电刺激干预前后24小时内

测量方法:

Measure time point of outcome:

Within 24 hours before and after transcranial direct current stimulation intervention.

Measure method:

指标中文名:

晚期正电位

指标类型:

主要指标

Outcome:

Late Positive Potential, LPP

Type:

Primary indicator

测量时间点:

经颅直流电刺激干预前后24小时内

测量方法:

Measure time point of outcome:

Within 24 hours before and after transcranial direct current stimulation intervention.

Measure method:

指标中文名:

顶中区N200

指标类型:

主要指标

Outcome:

N200 at the Parietal Midline Area

Type:

Primary indicator

测量时间点:

经颅直流电刺激干预前后24小时内

测量方法:

Measure time point of outcome:

Within 24 hours before and after transcranial direct current stimulation intervention.

Measure method:

指标中文名:

愉悦情绪体验量表

指标类型:

主要指标

Outcome:

The Temporal Experience of Pleasure Scale

Type:

Primary indicator

测量时间点:

基线,第2/5/7/10次干预后,6个月/12个月随访

测量方法:

Measure time point of outcome:

At baseline, after the 2nd, 5th, 7th, and 10th intervention sessions, and during the 6 and 12 month follow ups.

Measure method:

指标中文名:

Snaith-Hamilton快感量表

指标类型:

主要指标

Outcome:

Snaith-Hamilton Pleasure Scale

Type:

Primary indicator

测量时间点:

基线,第2/5/7/10次干预后,6个月/12个月随访

测量方法:

Measure time point of outcome:

At baseline, after the 2nd, 5th, 7th, and 10th intervention sessions, and during the 6 and 12 month follow ups.

Measure method:

指标中文名:

PHQ-9抑郁症筛查量表

指标类型:

次要指标

Outcome:

Patient Health Questionnaire-9 items, PHQ-9

Type:

Secondary indicator

测量时间点:

基线,第2/5/7/10次干预后,6个月/12个月随访

测量方法:

Measure time point of outcome:

At baseline, after the 2nd, 5th, 7th, and 10th intervention sessions, and during the 6 and 12 month follow ups.

Measure method:

指标中文名:

儿童期创伤问卷(CTQ),情绪忽视维度子量表

指标类型:

主要指标

Outcome:

Childhood Trauma Ques- tionnaire,emotional abuse

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

父母心理控制量表

指标类型:

主要指标

Outcome:

Parental Psychological Control Scale, PPCS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

父母教养方式问卷

指标类型:

主要指标

Outcome:

Parental Bonding Instrument, PBI

Type:

Primary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 28 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):

分组由独立于实验执行的研究人员完成。具体方法是:利用计算机软件(如 MATLAB 或 PsychoPy)生成随机数字序列,并依据此序列将参与者随机分配至各实验条件。

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

Randomization was performed by research personnel independent of the experiment execution. Specifically, a random number sequence was generated using computer software (e.g., MATLAB or PsychoPy), based on which participants were allocated to experimental conditions.

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:

单盲法,施盲对象为被试

Blinding:

Single‑blind design with participants blinded to group assignment.

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

是Yes

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):

于研究结果发表后三个月内公开原始数据,因涉及隐私信息,如需原始数据,请联系项目负责人获取。

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

Make the raw data publicly available within three months after the publication of research results; due to privacy concerns, please contact the project leader for access to the raw data.

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:

问卷数据通过软件(问卷星)收集,并由专业人员汇总整理至文档中保存。神经生理数据收集并保存至项目组硬盘中。

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

Questionnaire data were collected via software (Questionnaire Star) and compiled into documents by professionals. Neurophysiological data were collected and stored on the project group's hard drive.

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:

 2026-03-11 15:43:43