ChiCTR2500107057 版本V1.0 版本创建时间2025/08/01 18:56:21 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：

 ChiCTR2500107057 

最近更新日期：

Date of Last Refreshed on：

 2025-08-01 18:56:13 

注册时间：

Date of Registration：

 2025-08-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effectiveness of an immersive virtual reality (VR)-based mindfulness intervention (MI) to reduce depressive symptoms in patients with autoimmune arthritis (AA): a randomized control trial (RCT)

Public title：

Effectiveness of an immersive virtual reality (VR)-based mindfulness intervention (MI) to reduce depressive symptoms in patients with autoimmune arthritis (AA): a randomized control trial (RCT)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of an immersive virtual reality (VR)-based mindfulness intervention (MI) to reduce depressive symptoms in patients with autoimmune arthritis (AA): a randomized control trial (RCT)

Scientific title：

Effectiveness of an immersive virtual reality (VR)-based mindfulness intervention (MI) to reduce depressive symptoms in patients with autoimmune arthritis (AA): a randomized control trial (RCT)

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：

Wong Hon Tung 

研究负责人：

Wu Chung Ming, Timothy 

Applicant：

Wong Hon Tung 

Study leader：

Wu Chung Ming, Timothy 

申请注册联系人电话：

Applicant telephone：

 +852 3970 2968

研究负责人电话：

Study leader's
telephone：

+852 3970 8784

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：

 whontung.tony@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 tcmwu@hkmu.edu.hk

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：

研究负责人通讯地址：

Applicant address：

11th Floor, School of Nursing and Health Sciences, Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, 1 Sheung Shing Street, Homantin, Kowloon, Hong Kong.

Study leader's address：

11th Floor, School of Nursing and Health Sciences, Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, 1 Sheung Shing Street, Homantin, Kowloon, Hong Kong.

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：

School of Nursing and Health Sciences, Hong Kong Metropolitan University

Applicant's institution：

School of Nursing and Health Sciences, Hong Kong Metropolitan University

研究负责人所在单位：

School of Nursing and Health Sciences, Hong Kong Metropolitan University

Affiliation of the Leader：

School of Nursing and Health Sciences, Hong Kong Metropolitan 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：

 HE–HMRF2025/13

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：

Research Ethics Committee of Hong Kong Metropolitan University

Name of the ethic committee：

Research Ethics Committee of Hong Kong Metropolitan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-02 00:00:00

伦理委员会联系人：

Dr. Billy Wong

Contact Name of the ethic committee：

Dr. Billy Wong

伦理委员会联系地址：

Office of Research Affairs and Knowledge Transfer (Hong Kong Metropolitan University), Unit 501–502, 5/F, NEO, 123 Hoi Bun Road, Kwun Tong, Kowloon, Hong Kong

Contact Address of the ethic committee：

Office of Research Affairs and Knowledge Transfer (Hong Kong Metropolitan University), Unit 501–502, 5/F, NEO, 123 Hoi Bun Road, Kwun Tong, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2768 6251

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：

School of Nursing and Health Sciences, Hong Kong Metropolitan University

Primary sponsor：

School of Nursing and Health Sciences, Hong Kong Metropolitan University

研究实施负责（组长）单位地址：

11th Floor, School of Nursing and Health Sciences, Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, 1 Sheung Shing Street, Homantin, Kowloon, Hong Kong.

Primary sponsor's address：

11th Floor, School of Nursing and Health Sciences, Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, 1 Sheung Shing Street, Homantin, Kowloon, Hong Kong.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Hong Kong Metropolitan University

具体地址：

Hong Kong Metropolitan University, Homantin, Kowloon, Hong Kong

Institution
hospital：

Hong Kong Metropolitan University

Address：

Hong Kong Metropolitan University, Homantin, Kowloon, Hong Kong

经费或物资来源：

The Kadoorie Charitable Foundation Grant & Hong Kong Metropolitan University

Source(s) of funding：

The Kadoorie Charitable Foundation Grant & Hong Kong Metropolitan University

研究疾病：

Autoimmune arthritis  

Target disease：

Autoimmune arthritis

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To evaluate the effectiveness of an immersive VR-based mindfulness intervention program in reducing depressive symptoms among patients with autoimmune arthritis.  

Objectives of Study：

To evaluate the effectiveness of an immersive VR-based mindfulness intervention program in reducing depressive symptoms among patients with autoimmune arthritis.

药物成份或治疗方案详述：

The intervention group will receive six sessions of immersive VR-based mindfulness interventions (MIs) along with usual care. It includes a one-hour orientation and six weekly one-hour sessions, totaling seven hours, based on "Mindfulness: Finding Peace in a Frantic World." 

Description for medicine or protocol of treatment in detail：

The intervention group will receive six sessions of immersive VR-based mindfulness interventions (MIs) along with usual care. It includes a one-hour orientation and six weekly one-hour sessions, totaling seven hours, based on "Mindfulness: Finding Peace in a Frantic World." 

纳入标准：

Patients with AA aged 18 or above will be eligible. The inclusion criteria are: 1. being able to communicate in Cantonese, 2. presenting with depressive symptoms over the past two weeks based on the established criteria (DSM V) with a Patient Health Questionniare-9 score of at least five or above, 3. being able to commit to six consecutive weekly VR-based mindfulness sessions, and 4. on a stable medication regimen.

Inclusion criteria

Patients with AA aged 18 or above will be eligible. The inclusion criteria are: 1. being able to communicate in Cantonese, 2. presenting with depressive symptoms over the past two weeks based on the established criteria (DSM V) with a Patient Health Questionniare-9 score of at least five or above, 3. being able to commit to six consecutive weekly VR-based mindfulness sessions, and 4. on a stable medication regimen.

排除标准：

1. Severe visual or auditory deficits. 2. Severe organic disease or malignant tumour. 3. A history of motion or simulator sickness. 4. History of epilepsy. 5. A recent mental disorder in the past 12 months or current psychiatric disorder that are potentially life threatening (i.e. psychosis, suicidal ideation). 6. Meditation and yoga practice within the past 6 months or will plan to start mindfulness intervention.

Exclusion criteria：

1. Severe visual or auditory deficits. 2. Severe organic disease or malignant tumour. 3. A history of motion or simulator sickness. 4. History of epilepsy. 5. A recent mental disorder in the past 12 months or current psychiatric disorder that are potentially life threatening (i.e. psychosis, suicidal ideation). 6. Meditation and yoga practice within the past 6 months or will plan to start mindfulness intervention.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-01 00:00:00 至 To 2026-02-28 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 99

Group：

Intervention group

Sample size：

干预措施：

The intervention group in this study will receive six sessions of immersive VR-based MIs in addition to usual care.

干预措施代码：

Intervention：

The intervention group in this study will receive six sessions of immersive VR-based MIs in addition to usual care.

Intervention code：

组别：

Control group

样本量：

 99

Group：

Control group

Sample size：

干预措施：

Participants in the control group will receive usual care without immersive VR-based MI program.

干预措施代码：

Intervention：

Participants in the control group will receive usual care without immersive VR-based MI program.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Hong Kong Metropolitan University 

单位级别：

 University 

Institution
hospital：

Hong Kong Metropolitan University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Symptoms of depression

指标类型：

主要指标

Outcome：

Symptoms of depression

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

The Chinese version of the Depression Anxiety Stress Scales 21-items (DASS-21)

指标中文名：

Symptoms of anxiety and stress

指标类型：

次要指标

Outcome：

Symptoms of anxiety and stress

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

The Chinese version of the DASS-21

指标中文名：

Pain intensity

指标类型：

次要指标

Outcome：

Pain intensity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

The Chinese version of the Brief Pain Inventory (BPI)

指标中文名：

Pain self-efficacy

指标类型：

次要指标

Outcome：

Pain self-efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

The Chinese version of the Pain Self-Efficacy Questionnaire (PSEQ)

指标中文名：

Mindfulness level

指标类型：

次要指标

Outcome：

Mindfulness level

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

The Chinese version of the Short-Form Five Facet Mindfulness Questionnaire (SF-FFMQ)

指标中文名：

Patient satisfaction

指标类型：

次要指标

Outcome：

Patient satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

A self-developed patient satisfaction survey

指标中文名：

Adverse reactions

指标类型：

副作用指标

Outcome：

Adverse reactions

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Adverse reactions, including nausea, vomiting, motion sickness, and seizures will be monitored. Emerging motion sickness symptoms will be recorded on a designated form.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

NA

组织：

Sample Name：

NA

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 18 岁 years
最大 Max age NA 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）：

Eligible subjects will be individually randomized to the intervention or control group (1:1) using sequentially numbered, opaque, sealed envelopes (SNOSE), and block randomization. A statistician who is not part of the research team will generate the random numbers and assignment and prepare 198 identical opaque sealed A5-sized envelopes. The block randomization list will be created with a 1:1 allocation ratio and block size of 4, 8 and 12 in random order to ensure that a similar number of participants will be allocated to both groups.

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

Eligible subjects will be individually randomized to the intervention or control group (1:1) using sequentially numbered, opaque, sealed envelopes (SNOSE), and block randomization. A statistician who is not part of the research team will generate the random numbers and assignment and prepare 198 identical opaque sealed A5-sized envelopes. The block randomization list will be created with a 1:1 allocation ratio and block size of 4, 8 and 12 in random order to ensure that a similar number of participants will be allocated to both groups.

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：

Given the apparent nature of the intervention, it is unlikely to blind participants and intervention providers.

Blinding：

Given the apparent nature of the intervention, it is unlikely to blind participants and intervention providers.

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）：

The findings of the study will be disseminated in scientific journals and international conferences. Upon request, the project team will consider sharing raw data to advance scientific knowledge.

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

The findings of the study will be disseminated in scientific journals and international conferences. Upon request, the project team will consider sharing raw data to advance scientific knowledge.

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：

Data will be collected primarily through electronic Case Report Forms (eCRFs) using a validated Electronic Data Capture (EDC) system.

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

Data will be collected primarily through electronic Case Report Forms (eCRFs) using a validated Electronic Data Capture (EDC) system.

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：

  2025-08-01 18:56:13