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Efficacy of a mindfulness-based intervention with and without virtual reality support to promote mental health through self-compassion and mind wandering among university students: A randomised controlled trial
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注册号：

Registration number：

 ChiCTR2500108220 

最近更新日期：

Date of Last Refreshed on：

 2025-08-26 22:10:09 

注册时间：

Date of Registration：

 2025-08-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Efficacy of a mindfulness-based intervention with and without virtual reality support to promote mental health through self-compassion and mind wandering among university students: A randomised controlled trial

Public title：

Efficacy of a mindfulness-based intervention with and without virtual reality support to promote mental health through self-compassion and mind wandering among university students: A randomised controlled trial

注册题目简写：

Efficacy Mindfulness-based intervention with or without virtual reality support to promote mental health among university students

English Acronym：

Efficacy Mindfulness-based intervention with or without virtual reality support to promote mental health among university students

研究课题的正式科学名称：

Efficacy of a mindfulness-based intervention with and without virtual reality support to promote mental health through self-compassion and mind wandering among university students: A randomised controlled trial

Scientific title：

Efficacy of a mindfulness-based intervention with and without virtual reality support to promote mental health through self-compassion and mind wandering among university students: A randomised controlled trial

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：

Winnie Yuen 

研究负责人：

Winnie Wing Yan Yuen 

Applicant：

Winnie Yuen 

Study leader：

Winnie Wing Yan Yuen 

申请注册联系人电话：

Applicant telephone：

 +852 2104 8299

研究负责人电话：

Study leader's
telephone：

+852 2104 8299

申请注册联系人传真 ：

Applicant Fax：

 wyyuen@hksyu.edu

研究负责人传真：

Study leader's fax：

 wyyuen@hksyu.edu

申请注册联系人电子邮件：

Applicant E-mail：

 wyyuen@hksyu.edu

研究负责人电子邮件：

Study leader's E-mail：

 wyyuen@hksyu.edu

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：

10 Wai Tsui Crescent, Braemar Hill, North Point, Hong Kong

研究负责人通讯地址：

10 Wai Tsui Crescent, Braemar Hill, North Point, Hong Kong

Applicant address：

10 Wai Tsui Crescent, Braemar Hill, North Point, Hong Kong

Study leader's address：

10 Wai Tsui Crescent, Braemar Hill, North Point, 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：

Department of Counselling & Psychology, Hong Kong Shue Yan University

Applicant's institution：

Department of Counselling & Psychology, Hong Kong Shue Yan University

研究负责人所在单位：

Department of Counselling & Psychology, Hong Kong Shue Yan University

Affiliation of the Leader：

Department of Counselling & Psychology, Hong Kong Shue Yan 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：

 HREC 25-4 (40)

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：

Human Research Ethics Committee of Hong Kong Shue Yan University

Name of the ethic committee：

Human Research Ethics Committee of Hong Kong Shue Yan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-21 00:00:00

伦理委员会联系人：

Dr. Alex Li

Contact Name of the ethic committee：

Dr. Alex Li

伦理委员会联系地址：

LG106, Academic Building, Hong Kong Shue Yan University, 10 Wai Tsui Crescent, Braemar Hill Road, North Point

Contact Address of the ethic committee：

LG106, Academic Building, Hong Kong Shue Yan University, 10 Wai Tsui Crescent, Braemar Hill Road, North Point

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2806 8044

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：

Hong Kong Shue Yan University

Primary sponsor：

Hong Kong Shue Yan University

研究实施负责（组长）单位地址：

10 Wai Tsui Crescent, Braemar Hill Road, North Point

Primary sponsor's address：

10 Wai Tsui Crescent, Braemar Hill Road, North Point

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：

N/A

单位(医院)：

Department of Counselling and Psychology, Hong Kong Shue Yan University

具体地址：

10 Wai Tsui Crescent, Braemar Hill Road, North Point

Institution
hospital：

Department of Counselling and Psychology, Hong Kong Shue Yan University

Address：

10 Wai Tsui Crescent, Braemar Hill Road, North Point

经费或物资来源：

Source(s) of funding：

University Research Grants (URG/24/07), Hong Kong Shue Yan University

研究疾病：

N/A  

Target disease：

N/A

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：

The aims of the current study are to explore the effectiveness of combining mindfulness practices with VR technology in improving neuropsychological and mental health outcomes, as well as to gain better understanding of how mindfulness impact on mental wellbeing through self-compassion and mind wandering. Utilizing a two-arm RCT design, the objectives of the present study are: (1) To assess the effectiveness of mindfulness-based intervention (MBI) with VR component on neuropsychological and mental health outcomes among university students, and (2) To investigate the relationship among mindfulness, self-compassion, mind wandering, and mental health outcomes.  

Objectives of Study：

The aims of the current study are to explore the effectiveness of combining mindfulness practices with VR technology in improving neuropsychological and mental health outcomes, as well as to gain better understanding of how mindfulness impact on mental wellbeing through self-compassion and mind wandering. Utilizing a two-arm RCT design, the objectives of the present study are: (1) To assess the effectiveness of mindfulness-based intervention (MBI) with VR component on neuropsychological and mental health outcomes among university students, and (2) To investigate the relationship among mindfulness, self-compassion, mind wandering, and mental health outcomes.

药物成份或治疗方案详述：

The intervention is structured around mindfulness and self-compassion. Based on existing MBIs protocol, including mindful self-compassion and mindfulness-based cognitive therapy for life. Each session will involve theory, practice, inquiry, reflection and discussion. Three short VR mindfulness practices (mindful breathing, awareness, working with difficult emotions) will be introduced to participants before or after specific sessions at the VR cave of the University of Shue Yan. The control group will have the same contents except for the VR components. 

Description for medicine or protocol of treatment in detail：

The intervention is structured around mindfulness and self-compassion. Based on existing MBIs protocol, including mindful self-compassion and mindfulness-based cognitive therapy for life. Each session will involve theory, practice, inquiry, reflection and discussion. Three short VR mindfulness practices (mindful breathing, awareness, working with difficult emotions) will be introduced to participants before or after specific sessions at the VR cave of the University of Shue Yan. The control group will have the same contents except for the VR components. 

纳入标准：

Inclusion criteria

排除标准：

(1) with epilepsy or mental disorder diagnosis and currently on active medical or psychological treatment, and (2) likely to engage in immediate risk behaviour, such as suicide and/or violence.

Exclusion criteria：

(1) with epilepsy or mental disorder diagnosis and currently on active medical or psychological treatment, and (2) likely to engage in immediate risk behaviour, such as suicide and/or violence.

研究实施时间：

Study execute time：

从 From 2025-08-25 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-28 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 35

Group：

Intervention group

Sample size：

干预措施：

Six 90-minute group sessions of mindfulness and self-compassion intervention with three short VR mindfulness practices (mindful breathing, awareness, working with difficult emotions)

干预措施代码：

Intervention：

Six 90-minute group sessions of mindfulness and self-compassion intervention with three short VR mindfulness practices (mindful breathing, awareness, working with difficult emotions)

Intervention code：

组别：

Control group

样本量：

 35

Group：

Control group

Sample size：

干预措施：

Six 90-minute group sessions of mindfulness and self-compassion intervention only.

干预措施代码：

Intervention：

Six 90-minute group sessions of mindfulness and self-compassion intervention only.

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 Shue Yan University 

单位级别：

 University 

Institution
hospital：

Hong Kong Shue Yan University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Visual Attention, Task Switching and Cognitive Flexibility

指标类型：

主要指标

Outcome：

Visual Attention, Task Switching and Cognitive Flexibility

Type：

Primary indicator

测量时间点：

Baseline and post-intervention

测量方法：

Trail Making Test (TMT) (Reitan, 1956)

Measure time point of outcome：

Baseline and post-intervention

Measure method：

Trail Making Test (TMT) (Reitan, 1956)

指标中文名：

Cognitive ability through nonverbal problem-solving tasks

指标类型：

次要指标

Outcome：

Cognitive ability through nonverbal problem-solving tasks

Type：

Secondary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Test of Nonverbal Intelligence (Brown, Sherbenou, & Johnsen, 1997)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Test of Nonverbal Intelligence (Brown, Sherbenou, & Johnsen, 1997)

指标中文名：

Mental Health Problems

指标类型：

主要指标

Outcome：

Mental Health Problems

Type：

Primary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Depression Anxiety Stress Scale-21 item (Lovibond & Lovibond, 1995)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Depression Anxiety Stress Scale-21 item (Lovibond & Lovibond, 1995)

指标中文名：

DSM-5 symptoms of PTSD

指标类型：

主要指标

Outcome：

DSM-5 symptoms of PTSD

Type：

Primary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

The Post-traumatic Stress Disorder Checklist for DSM-5 (Weathers et al., 2013)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

The Post-traumatic Stress Disorder Checklist for DSM-5 (Weathers et al., 2013)

指标中文名：

Level of Resilience

指标类型：

次要指标

Outcome：

Level of Resilience

Type：

Secondary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Connor-Davidson Resilience Scale (CD-RISC) (Campbell-Sills & Stein, 2007)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Connor-Davidson Resilience Scale (CD-RISC) (Campbell-Sills & Stein, 2007)

指标中文名：

Level of Mindfulness and Self-awareness

指标类型：

次要指标

Outcome：

Level of Mindfulness and Self-awareness

Type：

Secondary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Five Facets of Mindfulness Questionnaire (FFMQ) (Baer et al., 2006)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Five Facets of Mindfulness Questionnaire (FFMQ) (Baer et al., 2006)

指标中文名：

Level of Self-compassion

指标类型：

主要指标

Outcome：

Level of Self-compassion

Type：

Primary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Self-compassion Scale-Short Form (Raes et al., 2011)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Self-compassion Scale-Short Form (Raes et al., 2011)

指标中文名：

Level of Mind Wandering

指标类型：

主要指标

Outcome：

Level of Mind Wandering

Type：

Primary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Mind Excessively Wandering Scale (Mowlem et al., 2019)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Mind Excessively Wandering Scale (Mowlem et al., 2019)

指标中文名：

Sleep Patterns and Disturbances related to Biological Rhythms

指标类型：

主要指标

Outcome：

Sleep Patterns and Disturbances related to Biological Rhythms

Type：

Primary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Chinese version of Biological Rhythms Interview of Assessment in Neuropsychiatry- Sleep subscale

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Chinese version of Biological Rhythms Interview of Assessment in Neuropsychiatry- Sleep subscale

指标中文名：

Attentional, Motor, and Non-planning Impulsivity

指标类型：

次要指标

Outcome：

Attentional, Motor, and Non-planning Impulsivity

Type：

Secondary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Brief Barratt Impulsivity Scale (Steinberg et al., 2013)

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

Brief Barratt Impulsivity Scale (Steinberg et al., 2013)

指标中文名：

Qualitative evaluation on intervention impacts on mental wellbeing

指标类型：

主要指标

Outcome：

Qualitative evaluation on intervention impacts on mental wellbeing

Type：

Primary indicator

测量时间点：

Post-intervention

测量方法：

Individual interviews

Measure time point of outcome：

Post-intervention

Measure method：

Individual interviews

指标中文名：

Resting Heart Rate

指标类型：

次要指标

Outcome：

Resting Heart Rate

Type：

Secondary indicator

测量时间点：

Baseline and Post-intervention

测量方法：

Measure time point of outcome：

Baseline and Post-intervention

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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 25 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）：

Predetermined block randomisation list generated by computer

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

Predetermined block randomisation list generated by computer

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：

None

Blinding：

None

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）：

N/A

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

N/A

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：

The anonymous nature of the questionnaire will be emphasized. The data collected through Qualtrics for this study will be kept confidential and used solely for research purposes. During the interview process, audio recordings will be made with participants' prior consent, and they have the right to review and delete part or all of the recordings at a later time. All identifiable data and information will be securely stored in password-protected files. The data collected in this study will only be reviewed by the principal investigator and co-investigators and will be destroyed after the completion of the interviews. Participants' names will not appear in any reports or publications. All collected data will be destroyed within five years after the publication of the first report.

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

The anonymous nature of the questionnaire will be emphasized. The data collected through Qualtrics for this study will be kept confidential and used solely for research purposes. During the interview process, audio recordings will be made with participants' prior consent, and they have the right to review and delete part or all of the recordings at a later time. All identifiable data and information will be securely stored in password-protected files. The data collected in this study will only be reviewed by the principal investigator and co-investigators and will be destroyed after the completion of the interviews. Participants' names will not appear in any reports or publications. All collected data will be destroyed within five years after the publication of the first report.

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：

  2025-08-26 22:10:01
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