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工作记忆训练改善快感缺失的迁移效应与机制研究
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注册号：

Registration number：

 ChiCTR2500100418 

最近更新日期：

Date of Last Refreshed on：

 2025-04-09 14:37:15 

注册时间：

Date of Registration：

 2025-04-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

工作记忆训练改善快感缺失的迁移效应与机制研究

Public title：

Research on the migration effect and mechanism of working memory training in improving anhedonia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

工作记忆训练对精神分裂症的快感缺失的影响

Scientific title：

The effects of working memory training on anhedonia in schizophrenia

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：

蒲婕 

研究负责人：

陈楚侨 

Applicant：

Jie Pu 

Study leader：

Raymond C. K. Chan 

申请注册联系人电话：

Applicant telephone：

 +86 198 1786 5513

研究负责人电话：

Study leader's
telephone：

+86 136 5130 5662

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：

 puj@psych.ac.cn

研究负责人电子邮件：

Study leader's E-mail：

 rckchan@psych.ac.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：

中国北京市朝阳区林萃路16号院

研究负责人通讯地址：

中国北京市朝阳区林萃路16号院

Applicant address：

No. 16 Lincui Road, Chaoyang District, Beijing, China

Study leader's address：

No. 16 Lincui Road, Chaoyang District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

 100101

研究负责人邮政编码：

Study leader's postcode：

 100101

申请人所在单位：

中国科学院心理研究所

Applicant's institution：

Institute of Psychology, Chinese Academy of Sciences

研究负责人所在单位：

中国科学院心理研究所

Affiliation of the Leader：

Institute of Psychology, Chinese Academy of Sciences

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 H24155, 2025科研第03号-202502KS-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：

中国科学院心理研究所伦理委员会，山东省戴庄医院伦理委员会

Name of the ethic committee：

Institutional Review Board of the Institute of Psychology, Chinese Academy of Sciences; Institutional Review Board of Shandong Daizhuang Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-11-15 00:00:00

伦理委员会联系人：

胡理

Contact Name of the ethic committee：

Li Hu

伦理委员会联系地址：

中国北京市朝阳区林萃路16号院

Contact Address of the ethic committee：

No. 16 Lincui Road, Chaoyang District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6485 1107

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：

中国科学院心理研究所

Primary sponsor：

Institute of Psychology, Chinese Academy of Sciences

研究实施负责（组长）单位地址：

中国北京市朝阳区林萃路16号院

Primary sponsor's address：

No. 16 Lincui Road, Chaoyang District, Beijing, 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)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国科学院心理研究所

具体地址：

中国北京市朝阳区林萃路16号院

Institution
hospital：

Institute of Psychology, Chinese Academy of Sciences

Address：

No. 16 Lincui Road, Chaoyang District, Beijing, China

国家：

中国

省(直辖市)：

山东

市(区县)：

济宁

Country：

China

Province：

Shandong

City：

Jining

单位(医院)：

山东省戴庄医院

具体地址：

中国山东省济宁市济戴路1号

Institution
hospital：

Shandong Daizhuang Hospital

Address：

No. 1 Jidai Road, Jining, Shandong, P. R. China

经费或物资来源：

科技创新2030 重大项目:脑疾病临床研究大数据与样本库平台建设 (20212D0200800)

Source(s) of funding：

Scientific and Technological Innovation 2030: Construction of Big Data and Sample Bank Platform for Clinical Research on Brain Diseases (20212D0200800)

研究疾病：

精神分裂症  

Target disease：

Schizophrenia

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：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究试图通过工作记忆训练认知干预，检验其对精神分裂症患者工作记忆功能及快感缺失症状的改善效果。并探讨其改善是否与静息状态的神经递质兴奋抑制水平及奖赏功能相关的脑激活与连接的改变有关。  

Objectives of Study：

The present study sought to examine the effects of a cognitive intervention of working memory training on the improvement of working memory capability and anhedonia symptoms in schizophrenic patients. And to explore whether the improvement is related to resting-state of neurotransmitter excitatory inhibition and alterations in brain activation and functional connectivity related to reward function.

药物成份或治疗方案详述：

本研究采用随机对照试验，平行设计。符合入组条件且自愿参与实验的被试被邀请到评估室，被试在了解具体的实验流程及细节后，签署知情同意书，随后完成包括脑成像扫描，临床症状评估、行为任务等在内的基线评估。基线测量后两日内，训练组患者在如常治疗之外接受为连续 5天每天2次共计10 次的工作记忆训练，对照组患者继续接受如常治疗。训练干预完成后，患者接受干预后评估，评估内容与基线测量相同，并完成脑成像扫描。训练组在常规治疗之外使用dual n back任务进行工作记忆训练 (Li et al., 2016)，任务过程中，在每一个试次中，被试会同时看到视觉刺激和听到音频刺激，需要判断他们当前看到的刺激以及听到的刺激是否与第n个trial前看到的和听到的刺激一样。刺激水平随被试的正确率提升而增加。对照组保持常规治疗。训练共计十次，每次半个小时，每天两次，持续五天。 

Description for medicine or protocol of treatment in detail：

This study was a randomised controlled trial with a parallel design. Subjects who met the enrollment criteria and volunteered to participate in the experiment were invited to the assessment room, where they signed an informed consent form after learning about the specific procedures and details of the experiment, and then completed the baseline assessment, including brain imaging scan, clinical symptom assessment, and behavioural tasks. Within two days of the baseline measurements, patients in the training group received 10 sessions of working memory training twice a day for 5 consecutive days in addition to the usual treatment, while patients in the control group continued to receive the usual treatment. Upon completion of the training intervention, patients underwent a post-intervention assessment, which was identical to the baseline measurements, and a brain imaging scan was completed. The training group underwent working memory training in addition to the usual treatment using the dual n back task (Li et al., 2016), during which, on each trial, subjects would simultaneously see visual stimuli and hear audio stimuli, and were required to judge whether the stimuli they were currently seeing as well as hearing were the same as the stimuli they had seen and heard before the nth trial. Stimulus levels increased as subjects got it right. The control group maintained the usual treatment. The training totalled ten sessions of half an hour each, twice a day for five days. 

纳入标准：

Inclusion criteria

排除标准：

（1）有其他精神疾病共病情况（如焦虑障碍，强迫症等）； （2）IQ低于70； （3）药物成瘾或物质滥用史； （4）脑创伤或神经系统疾病史； （5）非右利手； （6）在过去8周内接受MECT治疗； （7）2周内更换药物； （8） 体内有金属、幽闭恐惧症、怀孕等不适合参加脑成像扫描的情况。

Exclusion criteria：

1.Co-morbid conditions with other mental illnesses (e.g., anxiety disorders, obsessive-compulsive disorder, etc.); 2.IQ below 70; 3.History of drug addiction or substance abuse; 4.History of traumatic brain injury or neurological disorders; 5.Non-right-handedness; 6.MECT treatment within the past 8 weeks; 7.Change of medication within 2 weeks; 8.Unfit to participate in a brain imaging scan due to metal in the body, claustrophobia, pregnancy, etc.

研究实施时间：

Study execute time：

从 From 2025-04-15 00:00:00至 To 2026-04-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-15 00:00:00 至 To 2026-04-15 00:00:00

干预措施：

Interventions：

组别：

工作记忆训练组

样本量：

 30

Group：

Working memory training group

Sample size：

干预措施：

工作记忆训练+如常治疗。训练组在常规治疗之外使用dual n back任务进行工作记忆训练。任务过程中，在每一个试次中，被试会同时看到视觉刺激（九宫格中的灰色方块）和听到音频刺激（八种颜色之一），视觉刺激会在八个可能位置中随机出现，音频刺激会在八种颜色中随机出现，被试需要判断他们当前看到的刺激以及听到的刺激是否与第n个trial前看到的位置或听到的刺激一样。刺激水平随被试的正确率提升而增加。训练共计十次，每次半个小时，每天两次，持续五天。

干预措施代码：

Intervention：

Working memory training + treatment as usual. The training group used the dual n back task in addition to the business-as-usual treatment for working memory training , during the task, in each trial, subjects would simultaneously see a visual stimulus (grey squares in a nine-panel grid) and hear an audio stimulus (one of eight colours), with the visual stimulus appearing randomly in one of the eight possible locations, and the audio stimulus randomly appeared, and subjects were required to judge whether the stimulus they currently saw and the stimulus they heard was the same as the position they saw or the stimulus they heard before the nth trial. The stimulus level increased as the subject's correctness increased. The training consisted of a total of 10 sessions of half an hour each, twice a day for 5 days.

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control group

Sample size：

干预措施：

如常治疗，与同批次训练组一致，前测后五天后完成后测。

干预措施代码：

Intervention：

Treatment as usual, consistent with cohort training group, post-test completed five days after the pre-test.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

 济宁 

Country：

China

Province：

Shandong

City：

Jining

单位(医院)：

 山东省戴庄医院 

单位级别：

 三甲 

Institution
hospital：

Shandong Daizhuang Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

工作记忆能力

指标类型：

主要指标

Outcome：

Working memory capability

Type：

Primary indicator

测量时间点：

前测和后测

测量方法：

数字字符广度；数字倒背

Measure time point of outcome：

Baseline and Post-training

Measure method：

Letter Number Span; Digit Backwards

指标中文名：

快感缺失

指标类型：

主要指标

Outcome：

Anhedonia

Type：

Primary indicator

测量时间点：

前测和后测

测量方法：

阴性症状临床评估访谈；斯奈斯-汉密尔顿快感量表

Measure time point of outcome：

Baseline and Post-training

Measure method：

Clinical Assessment Interview for Negative Symptoms, CAINS; Snaith-Hamilton-Pleasure scale, SHAPS

指标中文名：

神经功能

指标类型：

次要指标

Outcome：

Neural Functional

Type：

Secondary indicator

测量时间点：

前测和后测

测量方法：

静息态磁共振脑功能成像；静息态波谱扫描; 情感奖赏延迟任务态脑成像

Measure time point of outcome：

Baseline and Post-training

Measure method：

Resting state functional magnetic resonance imaging, Rs-fMRI; Resting state Magnetic Resonance Spectroscopy, MRS; Affective Incentive Delay, AID

指标中文名：

临床症状

指标类型：

次要指标

Outcome：

Clinical Symptom

Type：

Secondary indicator

测量时间点：

前测和后测

测量方法：

阳性和阴性症状评定量表

Measure time point of outcome：

Baseline and Post-training

Measure method：

Positive and Negative Syndrome Scale

指标中文名：

奖赏加工

指标类型：

次要指标

Outcome：

Reward Function

Type：

Secondary indicator

测量时间点：

前测和后测

测量方法：

基于努力的决策任务

Measure time point of outcome：

Baseline and Post-training

Measure method：

Effort-Expenditure for Reward Task, EEfRT

指标中文名：

其他自我报告心理量表评分

指标类型：

附加指标

Outcome：

Other self report scales score

Type：

Additional indicator

测量时间点：

前测和后测

测量方法：

中文版时间性愉快体验量表；社会快感缺失量表；快感缺失评估量表；执行功能失常问卷；情绪表达性量表；中文版患者健康问卷；正负情绪状态量表

Measure time point of outcome：

Baseline and Post-training

Measure method：

The Temporal Experience of Pleasure Scale, TEPS; Revised Chinese Social Anhedonia Scale, RCSAS; Dimensional Anhedonia Rating Scale, DARS;Dysexecutive Questionnaire, DEX;Emotional Expressivity Scale, EES; Patient Health Questionnaire-9, PHQ-9; Positive and Negative Affect Scale, PANAS

指标中文名：

智商

指标类型：

附加指标

Outcome：

Intelligence Quotient

Type：

Additional indicator

测量时间点：

前测

测量方法：

韦氏智力量表中文版简版

Measure time point of outcome：

Baseline

Measure method：

Wechsler Adult Intelligence Scale

指标中文名：

抗精神病药物副作用

指标类型：

附加指标

Outcome：

Antipsychotic medicine adverse effect

Type：

Additional indicator

测量时间点：

前测

测量方法：

异常不自主运动量表；Barnes静坐不能量表

Measure time point of outcome：

Baseline

Measure method：

Abnormal Involuntary Movement Scale, AIMS; Barnes Akathisia Rating Scale, BARS

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 18 岁 years
最大 Max age 65 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）：

根据入组顺序将所有参与者编号为1-60号，使用R语言中的“randomizr”包，将被试随机分为两组。由专人确定分组，该人士不参与纳入病例与干预实验，并负责严格保存分配表。

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

All participants were numbered 1-60 according to the order of inclusion, and the subjects were randomly divided into two groups using the ‘randomizr’ package in the R language. The groups were determined by an experimener who was not involved in the inclusion of the cases and the intervention experiment, and who was responsible for keeping the allocation table strictly.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

患者分组信息由负责干预的实验人员保存，并对前后负责测量的实验人员保密。

Blinding：

Patient grouping information is kept confidential by the experimenter responsible for the intervention and the experimenter responsible for the measurement before and after.

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）：

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：

研究者应按调查问卷的填写要求，如实、详细、认真记录表中各项内容，确保内容真实、可靠。研究中所有观察结果和发现均应加以核实，确保研究中的各项结论均来源于原始数据。完成调查问卷由主要研究者审核后，在研究室的数据保管柜中专人负责保管，所有过程均记录在册，研究的档案保管、数据处理、有关检验结果等由专人管理。 在数据录入时，为保证数据的准确性，由一位数据管理员录入，并由另一位数据管理员校对。对病例报告表中存在的疑问，数据管理员将对此提出疑问并向研究者或评估员发出询问，研究者应尽快解答，数据管理员根据研究者的回答进行数据修改，确认与录入。试验结束且数据录入后，由研究者及数据库线管人员参加对数据进行核查，确认数据无误后对数据进行锁定。随后导出锁定的数据供统计分析用。

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

The researcher should record the contents of the form truthfully, in detail and carefully according to the requirements for completing the questionnaire to ensure that the contents are true and reliable. All observations and findings in the study should be verified to ensure that all conclusions in the study are derived from the original data. After the completion of the questionnaire was reviewed by the principal investigator, it was kept in the data storage cabinet in the research room by a special person, and all the processes were recorded in the book, and the archival storage, data processing, and relevant test results of the study were managed by a special person. During data entry, to ensure the accuracy of the data, it was entered by one data manager and proofread by another data manager. In case of doubt in the case report form, the data manager will ask questions and send queries to the investigator or assessor, the investigator should answer as soon as possible, and the data manager will modify, confirm and enter the data according to the investigator's answer. At the end of the trial and after data entry, the data will be verified by the researcher and the database line manager, and the data will be locked after confirming that the data are correct. The locked data were then exported for statistical analysis.

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：

  2025-04-09 14:37:03
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