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基于虚拟现实技术的暴露疗法和厌恶疗法对酒精依赖患者的综合疗效评价
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注册号：

Registration number：

 ChiCTR2500110026 

最近更新日期：

Date of Last Refreshed on：

 2025-09-29 09:00:34 

注册时间：

Date of Registration：

 2025-09-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于虚拟现实技术的暴露疗法和厌恶疗法对酒精依赖患者的综合疗效评价

Public title：

Comprehensive efficacy evaluation of exposure therapy and aversion therapy based on virtual reality technology for patients with alcohol dependence

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于虚拟现实技术的暴露疗法和厌恶疗法对酒精依赖患者的综合疗效评价

Scientific title：

Comprehensive efficacy evaluation of exposure therapy and aversion therapy based on virtual reality technology for patients with alcohol dependence

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：

赵浩宇 

研究负责人：

赵浩宇 

Applicant：

Zhao Haoyu 

Study leader：

Zhao Haoyu 

申请注册联系人电话：

Applicant telephone：

 +86 155 3903 6675

研究负责人电话：

Study leader's
telephone：

+86 155 3903 6675

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：

 870947891@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 870947891@qq.com

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：

河南省新乡市牧野区前进路207号

研究负责人通讯地址：

河南省新乡市牧野区前进路207号

Applicant address：

207 Qianjin Road, Muye District, Xinxiang City, Henan Province

Study leader's address：

207 Qianjin Road, Muye District, Xinxiang City, Henan Province

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：

新乡医学院第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Xinxiang Medical University

研究负责人所在单位：

新乡医学院第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Xinxiang Medical University

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：

 XYEFYLL—(科研)-2024-58

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：

新乡医学院第二附属医院伦理委员会

Name of the ethic committee：

Ethics Committee, The Second Affiliated Hospital of Xinxiang Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-20 00:00:00

伦理委员会联系人：

朱丽芳

Contact Name of the ethic committee：

Zhu Lifang

伦理委员会联系地址：

河南省新乡市牧野区前进路191号

Contact Address of the ethic committee：

No. 191, Qianjin Road, Muye District, Xinxiang City, Henan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 183 0365 8298

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：

新乡医学院第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Xinxiang Medical University

研究实施负责（组长）单位地址：

新乡医学院第二附属医院

Primary sponsor's address：

The Second Affiliated Hospital of Xinxiang Medical University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河南省

市(区县)：

新乡市

Country：

China

Province：

Henan Province

City：

Xinxiang City

单位(医院)：

新乡医学院第二附属医院

具体地址：

河南省新乡市牧野区前进路207号

Institution
hospital：

The Second Affiliated Hospital of Xinxiang Medical University

Address：

207 Qianjin Road, Muye District, Xinxiang City, Henan Province

经费或物资来源：

河南省科技研发联合基金（产业类）项目资金（项目编号：235101610004）资助

Source(s) of funding：

Funded by Henan Provincial joint fund for scientific and technological research and development (industry) project fund (Project No.: 235101610004)

研究疾病：

酒精依赖  

Target disease：

Alcohol dependence

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：

探索VR-CET、VR-AT和VR-CET+AT对AD患者心理渴求及降低复饮率的效果，形成AD的VR治疗新模式。  

Objectives of Study：

Objective to explore the effects of VR-CET, vr-at and VR-CET+at on psychological craving and reducing rehydration rate in patients with AD, and to form a new model of VR treatment for AD.

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.有严重的躯体疾病或脑器质性疾病史； 2.有除酒精和尼古丁之外的其他物质滥用史； 3.有其他精神疾病史； 4.有妨碍观看虚拟现实环境的视觉问题；

Exclusion criteria：

1.Have a history of serious physical disease or brain organic disease; 2.Have a history of substance abuse other than alcohol and nicotine; 3.Have a history of other mental diseases; 4.Visual problems that hinder viewing virtual reality environment.

研究实施时间：

Study execute time：

从 From 2024-09-01 00:00:00至 To 2025-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-22 00:00:00 至 To 2025-05-12 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 20

Group：

Ccontrol group

Sample size：

干预措施：

对照组接受临床常规治疗，并予以观看前述VR放松场景，在入院初期给予苯二氮卓类药物替代治疗为主，同时补充足量B族维生素，根据病情予以相应的抗精神病药物、抗抑郁剂或情感稳定剂治疗，合并必要的对症支持治疗，躯体戒断症状消失后逐渐停用苯二氮卓类药物。观看VR放松场景为期15天，共8次，每次间隔1天，每次时间约为10min，在第一次与最后一次试验进行时还需分别加上1次VR-CET治疗以采集到眼动数据及抓取数据

干预措施代码：

Intervention：

The control group received routine clinical treatment and watched the above VR relaxation scene. At the initial stage of admission, the patients were mainly given benzodiazepine replacement therapy, and at the same time, they were supplemented with sufficient B vitamins. According to the condition, they were given corresponding antipsychotics, antidepressants or emotional stabilizers, combined with necessary symptomatic support treatment. After the physical withdrawal symptoms disappeared, the benzodiazepines were gradually stopped. Watch the VR relaxation scene for 15 days, a total of 8 times, with an interval of 1 day, each time for about 10min. During the first and last trials, one VR-CET treatment should be added respectively to collect eye movement data and capture data.

Intervention code：

组别：

VR-AT组

样本量：

 20

Group：

VR-AT group

Sample size：

干预措施：

VR-AT组接受临床常规治疗，并予以VR厌恶治疗，为期15天，共8次，每次间隔1天，每次时间约为10min，在第一次与最后一次试验进行时还需分别加上1次VR-CET治疗以采集到眼动数据及抓取数据（VR-CET治疗详情见下文），四种不同场景的视频每个视频播放两次，研究由一名受过VR培训的精神科医生进行。

干预措施代码：

Intervention：

The vr-at group received conventional clinical treatment and VR aversion treatment for 15 days, a total of 8 times, with an interval of 1 day, each time for about 10min. During the first and last trials, one VR-CET treatment was added to collect eye movement data and capture data (see the details of VR-CET treatment below). Videos of four different scenes were played twice each. The study was conducted by a VR trained psychiatrist.

Intervention code：

组别：

VR-CET组

样本量：

 20

Group：

VR-CET group

Sample size：

干预措施：

VR-CET组在接受常规临床治疗的基础上，联合运用VR-CET治疗，为期15天，共8次，每次间隔1天，每次时间约为10min。VR-CET治疗所采用的播放设备为HTC VIVE Focus 3头戴式VR智能眼镜。治疗所采用的暴露场景为我们之前与西安慧云医疗科技股份有限公司合作完成的餐馆风格的暴露场景，该暴露场景的布局主要包含餐馆酒柜、前台凉菜区、冰柜、餐桌及两台电视机，场景总面积为70平方米，受试者可在该场景内任意活动，且视角可360°旋转，保证每个方位和角落可供受试者自由观察。在餐桌上分布着酒精线索及非酒精线索各17件，基于HTC VIVE Focus 3头戴式VR智能眼镜的摄像头动作捕捉技术，患者可以伸手去抓取餐桌上的酒精或非酒精线索模型，同时会被西安慧云医疗科技股份有限公司所制作的酒精渴求评估系统将抓取数据所记录下来，其数据内容有“酒精线索抓取用时”、“酒精线索抓取次数”、“非酒精线索抓取用时”、“非酒精线索抓取次数”。基于HTC VIVE Focus 3头戴式VR智能眼镜眼动追踪配件所提供的眼动追踪技术，患者在场景中眼神所注视的任何地方都会被眼动追踪配件所捕捉，当患者眼神注视到酒精线索或非酒精线索时，就会被上述酒精渴求评估系统将眼动数据所记录下来，其数据内容有“酒精线索注视用时”、“酒精线索注视次数”、“非酒精线索注视用时”、“非酒精线索注视次数”。在进行VR-CET治疗时，由一名受过VR训练的精神科医师进行。

干预措施代码：

Intervention：

On the basis of conventional clinical treatment, VR-CET group was treated with VR-CET for 15 days, a total of 8 times, with an interval of 1 day, and each time was about 10 minutes. The playback device used in VR-CET treatment is HTC vive focus 3 head mounted VR intelligent glasses. The exposure scene used in the treatment is a restaurant style exposure scene that we previously completed in cooperation with Xi'an Huiyun Medical Technology Co., Ltd. the layout of the exposure scene mainly includes the restaurant wine cabinet, the front cold dish area, the freezer, the dining table and two TV sets. The total area of the scene is 70 square meters. The subjects can move freely in the scene, and the angle of view can be rotated 360 degrees to ensure that each direction and corner can be observed freely by the subjects. There are 17 alcohol clues and 17 non-alcoholic clues on the table. Based on the camera motion capture technology of HTC vive focus 3 head mounted VR smart glasses, patients can reach out to grab alcohol or non-alcoholic clue models on the table. At the same time, the captured data will be recorded by the alcohol craving assessment system made by Xi'an Huiyun Medical Technology Co., Ltd., and its data content includes "alcohol clue capture time", "alcohol clue capture times", "non-alcoholic clue capture time", "non-alcoholic clue capture times". Based on the eye tracking technology provided by HTC vive focus 3 headworn VR intelligent glasses eye tracking accessories, the eye tracking accessories will capture any place the patient looks at in the scene. When the patient looks at alcohol clues or non-alcoholic clues, the eye tracking data will be recorded by the above alcohol craving assessment system. The data content includes "alcohol clue fixation time", "alcohol clue fixation times", "non-alcoholic clue fixation time", "non-alcoholic clue fixation times". The VR-CET treatment was performed by a psychiatrist trained in VR.

Intervention code：

组别：

VR-CET+AT组

样本量：

 20

Group：

VR-CET+AT group

Sample size：

干预措施：

VR-CET+AT组在接受上述常规临床治疗的基础上，联合运用VR-CET+AT治疗，为期15天，共8次，每次间隔1天，每次时间约为20min，每次治疗都包含一次VR-CET治疗及VR-AT治疗。

干预措施代码：

Intervention：

In the VR-CET+at group, on the basis of the above conventional clinical treatment, VR-CET+at was combined for 15 days, a total of 8 times, with an interval of 1 day, each time for about 20 minutes. Each treatment included one VR-CET treatment and vr-at treatment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

 新乡 

Country：

China

Province：

Henan

City：

Xinxiang

单位(医院)：

 新乡医学院第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Xinxiang Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

临床酒精戒断状态评定量表评分

指标类型：

次要指标

Outcome：

Clinical Alcohol Withdrawal Scale Rating

Type：

Secondary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由一名固定的精神科医师面对面询问患者，并用纸质版临床酒精戒断状态评定量表记录结果。

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

A fixed psychiatrist asked the patient face to face and recorded the results with a paper version of the scale.

指标中文名：

视觉模拟量表评分

指标类型：

主要指标

Outcome：

Visual Analog Scale Score

Type：

Primary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由一名固定的精神科医师面对面询问患者，并用纸质版视觉模拟量表记录结果。

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

A fixed psychiatrist asked the patient face to face and recorded the results with a paper version of the scale.

指标中文名：

宾夕法尼亚酒精渴求量表评分

指标类型：

主要指标

Outcome：

Penn Alcohol Craving Scale Score

Type：

Primary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由一名固定的精神科医师面对面询问患者，并用纸质版宾夕法尼亚酒精渴求量表记录结果。

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

A fixed psychiatrist asked the patient face to face and recorded the results with a paper version of the scale.

指标中文名：

汉密尔顿焦虑量表评分

指标类型：

主要指标

Outcome：

Hamilton Anxiety Scale score

Type：

Primary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由一名固定的精神科医师面对面询问患者，并用纸质版汉密尔顿焦虑量表记录结果。

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

A fixed psychiatrist asked the patient face to face and recorded the results with a paper version of the scale.

指标中文名：

汉密尔顿抑郁量表评分

指标类型：

主要指标

Outcome：

Depression symptom level (Hamilton Depression Rating Scale score)

Type：

Primary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由一名固定的精神科医师面对面询问患者，并用纸质版汉密尔顿抑郁量表记录结果。

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

A fixed psychiatrist asked the patient face to face and recorded the results with a paper version of the scale.

指标中文名：

匹兹堡睡眠质量指数量表评分

指标类型：

主要指标

Outcome：

Pittsburgh Sleep Quality Index score

Type：

Primary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由一名固定的精神科医师面对面询问患者，并用纸质版匹兹堡睡眠质量指数量表记录结果。

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

A fixed psychiatrist asked the patient face to face and recorded the results with a paper version of the scale.

指标中文名：

复饮情况

指标类型：

主要指标

Outcome：

Rehydration

Type：

Primary indicator

测量时间点：

干预后4周、干预后12周评估

测量方法：

通过电话随访询问患者的复饮情况

Measure time point of outcome：

4 weeks after intervention and 12 weeks after intervention

Measure method：

Telephone follow-up

指标中文名：

眼动数据

指标类型：

主要指标

Outcome：

Eye movement data

Type：

Primary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由HTC VIVE Focus 3头戴式VR智能眼镜及眼动追踪配件配合西安慧云医疗科技股份有限公司所制作的酒精渴求评估系统测量

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

Measurement of alcohol craving assessment system made by HTC vive focus 3 head mounted VR smart glasses and eye tracking accessories in conjunction with Xi'an Huiyun Medical Technology Co., Ltd

指标中文名：

抓取数据

指标类型：

主要指标

Outcome：

Grab data

Type：

Primary indicator

测量时间点：

基线期、干预后1天评估

测量方法：

由HTC VIVE Focus 3头戴式VR智能眼镜配合西安慧云医疗科技股份有限公司所制作的酒精渴求评估系统测量

Measure time point of outcome：

Baseline and 1 day after intervention

Measure method：

Measurement of alcohol craving assessment system made by HTC vive focus 3 wearable VR smart glasses and Xi'an Huiyun Medical Technology Co., Ltd

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：

结束

/Completed

年龄范围：

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

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用随机数字表法进行分组。由一名未参与研究实施及结局评估的独立研究人员利用随机数字表生成随机序列，并根据随机序列将受试者分配至对照组、VR-AT组、VR-CET组及VR-CET+AT组。该研究人员仅负责随机序列的生成与保存，不参与后续的入组、干预及评估工作，以确保随机分组的独立性和公正性。

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

Randomization was performed using a random number table. The random sequence was generated by an independent researcher who was not involved in the implementation or outcome assessment of the study. According to the sequence, participants were assigned to the control group, VR-AT group, VR-CET group, or VR-CET+AT group. The researcher who generated the random sequence was responsible only for producing and safeguarding the sequence and did not participate in recruitment, intervention, or assessment, thereby ensuring the independence and fairness of randomization.

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：

本研究在研究过程中采用单盲法。由于干预形式的特殊性（VR不同场景内容），受试者和实施干预的研究人员无法完全实现盲法。但在结局评估和数据统计环节，均由未参与分组与干预的独立评估人员完成，他们在整个过程中对受试者所属分组不知情。所有量表评分（PACS、HAMD、HAMA、PSQI、VAS）、客观指标（眼动、抓取数据）及电话随访的收集与录入均由独立评估员完成，数据分析也由另一名独立统计人员在去除分组标记后进行，以减少观察者偏倚。

Blinding：

This study adopted a single-blind design. Due to the particularity of the intervention (different VR scenario contents), it was not feasible to blind participants and intervention implementers completely. However, outcome assessment and data analysis were conducted by independent evaluators who were not involved in group allocation or intervention delivery, and who remained unaware of participants’ group assignments throughout the study. All scale assessments (PACS, HAMD, HAMA, PSQI, VAS), objective measures (eye-tracking and grasping data), and follow-up data collected via telephone were gathered and recorded by independent assessors. Data analysis was performed by another independent statistician after group identifiers had been removed, in order to minimize observer bias.

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2025年12月31日公布数据，ResMan临床试验公共管理平台http://www.medresman.org.cn/login.aspx

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

Data released on December 31, 2025, ResMan Clinical Trial Public Management Platform http://www.medresman.org.cn/login.aspx

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：

病例记录表

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-09-29 09:00:19
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