ChiCTR2600117770 版本V1.1 版本创建时间2026/05/28 17:32:32 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：

 ChiCTR2600117770 

最近更新日期：

Date of Last Refreshed on：

 2026-01-28 16:00:54 

注册时间：

Date of Registration：

 2026-01-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

針對完成靜觀減壓/靜觀認知療法學員的8週深度靜觀訓練計畫： 一項試驗性隨機對照試驗

Public title：

8-Week Deeper Mindfulness Program for MBSR/MBCT Completers: A Pilot RCT

注册题目简写：

English Acronym：

研究课题的正式科学名称：

8-Week Deeper Mindfulness Program for MBSR/MBCT Completers: A Pilot RCT

Scientific title：

8-Week Deeper Mindfulness Program for MBSR/MBCT Completers: A Pilot 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：

张德杏 

研究负责人：

张德杏 

Applicant：

Dexing ZHANG 

Study leader：

Dexing ZHANG 

申请注册联系人电话：

Applicant telephone：

 +852 2766 6546

研究负责人电话：

Study leader's
telephone：

+852 2766 6546

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：

 daisy.dx.zhang@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 daisy.dx.zhang@polyu.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：

香港理工大学护理学院GH5楼, 517室

研究负责人通讯地址：

香港理工大学护理学院GH5楼, 517室

Applicant address：

GH517, 5/F, School of Nursing, The Hong Kong Polytechnic University

Study leader's address：

GH517, 5/F, School of Nursing, The Hong Kong Polytechnic University

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：

香港理工大学护理学院

Applicant's institution：

School of Nursing, The Hong Kong Polytechnic University

研究负责人所在单位：

香港理工大学护理学院

Affiliation of the Leader：

School of Nursing, The Hong Kong Polytechnic 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：

 HSEARS20251223003

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：

理大院校审查委员会

Name of the ethic committee：

PolyU Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-08 00:00:00

伦理委员会联系人：

YING Tin Cheung

Contact Name of the ethic committee：

YING Tin Cheung

伦理委员会联系地址：

香港九龙红磡香港理工大学理大院校审查委员会

Contact Address of the ethic committee：

PolyU Institutional Review Board,The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3400 8541

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 htmying@polyu.edu.hk

研究实施负责（组长）单位：

香港理工大学护理学院

Primary sponsor：

School of Nursing, The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

香港九龙红磡香港理工大学

Primary sponsor's address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港特别行政区

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港理工大学护理学院

具体地址：

香港九龙红磡香港理工大学

Institution
hospital：

School of Nursing, The Hong Kong Polytechnic University

Address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

经费或物资来源：

香港研究资助局

Source(s) of funding：

Research Grants Council (RGC) of Hong Kong

研究疾病：

焦虑和/或抑郁  

Target disease：

anxiety and/or depression

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

目标是：1）检验试点 RCT 项目的可行性和可接受性，以及在真实世界群体环境中的任何实施问题；2）评估更深入的后续正念干预是否可以进一步改善参与者的生活质量和心理健康（例如，减少倦怠、压力、抑郁等）。  

Objectives of Study：

The objectives are 1) to examine the pilot RCT program’s feasibility and acceptability as well as any implementation issues in a real-world group setting, and 2) to assess whether a deeper follow-on mindfulness intervention can further improve participants’ quality of life and mental health (e.g. reducing burnout, stress, depression, etc.).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

参与者必须符合以下所有条件： 1. 年满18周岁（成年人），无年龄上限（只要在职即可）。 2. 目前从事任何职业，至少有兼职或全职工作。 3. 曾完成为期8周的正念减压疗法（MBSR）或正念认知疗法（MBCT）课程（需提供证书或结业证明）。这确保参与者在参加更深入的正念课程之前，已具备一定的正念训练基础（MBSR/MBCT）。 4. 能够每周参加一次线下小组课程，持续8周，并承诺尽量减少缺席（例如，缺席次数不得超过2次）。 5. 能够理解并使用粤语交流（课程和材料均以粤语提供）。 6. 愿意提供知情同意书并遵守研究流程（包括填写问卷和接受访谈）。

Inclusion criteria

Participants must meet all of the following criteria: 1. Age 18 or above (adult), with no upper age cap (as long as they are active in the workforce). 2. Currently employed at least part-time or full-time in any occupation. 3. Completed an 8-week MBSR or MBCT course in the past (certificate or verification of attendance would be requested). This ensures a baseline level of mindfulness training experience with the structured foundation course (MBSR/MBCT) before attending deeper mindfulness course. 4. Able to attend in-person group sessions weekly for 8 weeks, with a commitment to minimal absences (e.g. can miss no more than 2 sessions). 5. Able to understand and communicate in Cantonese (the course and materials will be in Cantonese). 6. Willing to provide informed consent and comply with study procedures (including completing questionnaires and an interview).

排除标准：

如有以下任何情况，申请人将被排除在外： 1. 语言障碍：无法沟通和理解粤语，因为干预将以粤语进行； 2. 严重精神健康状况：任何当前存在的严重精神疾病或急性精神健康危机，会影响参与或安全。例如，活动性精神病、当前药物依赖或急性自杀意念均会导致被排除在外，并转介至适当的医疗机构。我们将在入组评估中筛查此类情况。（较轻的疾病，例如已控制的焦虑或抑郁症，并非自动排除，但会根据具体情况进行评估。） 3. 严重疾病：任何严重的急性疾病或认知障碍，导致无法参加每周的小组活动或进行正念练习（例如，严重的未控制癫痫或严重的神经认知障碍）； 4. 正在接受其他强化治疗：在研究期间正在接受其他结构化心理治疗或基于正念的干预。如果参与者在研究期间开始接受新的心理治疗或其他冥想课程，他们会被邀请向研究团队报告，以避免混淆效应。（但是，如果参与者正在接受稳定的药物治疗或维持治疗，只要在试验期间没有发生任何变化，他们就可以被纳入研究。） 5. 无法参加：无法保证按时参加（例如，计划长时间旅行导致错过两次以上的课程）。由于小组凝聚力非常重要，因此，如果参与者事先知道自己无法参加大部分课程，则不会被纳入研究。 6. 其他因素：研究人员认为可能导致参与不安全或数据无效的任何其他问题。例如，如果候选人之前的正念减压（MBSR）指导老师指出其存在严重困难，或者该候选人有在小组环境中扰乱秩序的行为记录，我们将认为其不符合入选条件（尽管这种情况不太可能发生）。此标准旨在确保参与者能够适当地参与团体正念课程。

Exclusion criteria：

Applicants will be excluded if any of the following apply: 1. Language barrier: Unable to communicate and understand Cantonese as the intervention will be conducted in Cantonese; 2. Serious mental health conditions: Any current severe psychiatric disorder or acute mental health crisis that would interfere with participation or safety. For example, active psychosis, current substance dependence, or acute suicidal ideation would warrant exclusion and referral to appropriate care. We will screen for such conditions in the intake. (Milder conditions like managed anxiety or depression are not automatic exclusions, but may be evaluated case-by-case.) 3. Serious medical conditions: Any significant acute medical issue or cognitive impairment that makes it impossible to participate in weekly group sessions or perform mindfulness exercises (e.g. severe uncontrolled epilepsy or significant neurocognitive disorder) 4. Concurrent intensive treatment: Currently undergoing another structured psychotherapy or mindfulness-based intervention during the study period. As participants start a new psychological treatment or another meditation course while in the study, they are invited to report to the research team in order to avoid confounding effects. (However, those on stable medication or in stable maintenance therapy can be included, as long as no changes occur during the trial.) 5. Lack of availability: Unable to commit to the schedule (e.g. planning prolonged travel such that more than 2 sessions would be missed). Since group cohesion is important, those who know in advance they cannot attend the majority of sessions will not be enrolled. 6. Other factors: Any other issue that, in the investigators’ judgment, would make participation unsafe or data invalid. For example, if a candidate’s prior MBSR instructor noted serious difficulties or if the person had a history of disruptive behavior in group settings, we would consider that ineligibility (though this is unlikely). This criterion aligns with ensuring participants can appropriately engage in a group mindfulness course.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2027-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-01 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：

干预组：为期 8 周的深度正念课程

样本量：

 15

Group：

Intervention Group: 8-Week Deeper Mindfulness Program

Sample size：

干预措施：

随机分配到干预组的参与者将接受为期8周的“深度正念”课程，这是一个专为已完成基础正念减压疗法/正念认知疗法（MBSR/MBCT）的个体设计的后续项目。该项目着重强调感受音调（vedanā）的正念以及其他旨在深化练习的高级正念练习，使其超越基础层面。课程旨在通过聚焦感受音调（vedanā）的概念来深化正念练习。每次课程都会引入一个特定的主题，例如扎根、与纷乱的思绪和解、发现“事物的感受”、恢复平衡以及探索意识边缘的感受音调。参与者每周都会收到讲义或练习册，其中总结了关键概念和练习，以支持学习和练习。

干预措施代码：

Intervention：

Participants randomized to the intervention will receive an 8-week "Deeper Mindfulness" course, which is a follow-up program specifically designed for individuals who have completed basic MBSR/MBCT. This program specifically emphasizes mindfulness of feeling tone (vedanā) and other advanced mindfulness practices intended to deepen one’s practice beyond the foundational level. The curriculum is designed to deepen mindfulness practice by focusing on the concept of feeling tone (vedanā). Each session will introduce a specific theme, such as grounding, befriending the scattered mind, discovering the "feel-of-things," restoring balance, and exploring feeling tone at the edges of awareness. Participants will receive weekly handouts or workbook pages summarizing key concepts and exercises to support learning and practice.

Intervention code：

组别：

对照组：常规护理对照组

样本量：

 15

Group：

Control Group: Usual Care Control

Sample size：

干预措施：

随机分配到对照组的参与者将接受常规护理。参与者可以继续他们已有的任何个人正念练习，但在试验期间不会提供任何系统性的训练或额外资源。研究结束后，对照组参与者将参加一次由同一位正念导师或其他合格教师带领的、时长两小时的小组课程。小组课程将概述“深度正念”，并介绍情绪基调的概念，形式为信息讲解工作坊。

干预措施代码：

Intervention：

Participants randomized to the control group will receive their usual care. Participants may continue any personal mindfulness practices they already engage in, but no systematic training or additional resources will be provided during the trial. After the study completed, control group participants will attend a two-hour group session led by the same mindfulness instructor or another qualified teacher. This session will provide an overview of "deeper mindfulness" and introduce the concept of feeling tone, functioning as an informational workshop.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港特别行政区 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 香港理工大学 

单位级别：

 大学 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

The World Health Organization Quality of Life instrument (WHOQOL-BREF)

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

The World Health Organization Quality of Life instrument (WHOQOL-BREF)

指标中文名：

抑郁、焦虑和压力

指标类型：

主要指标

Outcome：

Depression, Anxiety, and Stress

Type：

Primary indicator

测量时间点：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

The Depression Anxiety Stress Scales (DASS-21)

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

The Depression Anxiety Stress Scales (DASS-21)

指标中文名：

倦怠

指标类型：

主要指标

Outcome：

Burnout

Type：

Primary indicator

测量时间点：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

the Maslach Burnout Inventory (MBI)

指标中文名：

失眠严重程度

指标类型：

次要指标

Outcome：

Insomnia Severity

Type：

Secondary indicator

测量时间点：

测量方法：

Insomnia Severity Index (ISI)

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

Insomnia Severity Index (ISI)

指标中文名：

孤独

指标类型：

次要指标

Outcome：

Loneliness

Type：

Secondary indicator

测量时间点：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

The UCLA Loneliness Scale

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

The UCLA Loneliness Scale

指标中文名：

心理灵活性/僵化

指标类型：

次要指标

Outcome：

Psychological Flexibility/Inflexibility

Type：

Secondary indicator

测量时间点：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

24-item Multidimensional Psychological Flexibility Inventory (MPFI-24)

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

24-item Multidimensional Psychological Flexibility Inventory (MPFI-24)

指标中文名：

人生的意义

指标类型：

次要指标

Outcome：

Meaning in Life

Type：

Secondary indicator

测量时间点：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

The Meaning in Life Questionnaire (MLQ)

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

The Meaning in Life Questionnaire (MLQ)

指标中文名：

正念水平和正念练习

指标类型：

次要指标

Outcome：

Mindfulness Level and Mindfulness Practice

Type：

Secondary indicator

测量时间点：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

FFMQ-20

Measure time point of outcome：

baseline (pre-intervention, Week 0, T0), post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

FFMQ-20

指标中文名：

不良反应

指标类型：

副作用指标

Outcome：

Adverse effects

Type：

Adverse events

测量时间点：

post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

测量方法：

questionnaire and interview

Measure time point of outcome：

post-intervention (Week 8, T1), and follow-up (1-month post-intervention, approximately Week 12, T2)

Measure method：

questionnaire and interview

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

 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 N/A 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）：

基线评估后将进行随机分组。一位独立研究人员将使用计算机生成的随机序列，将参与者平均分配到两个组（“深度正念组”和“对照组”）。

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

Randomization will be conducted after baseline assessments. An independent researcher will use a computer-generated random sequence to allocate participants equally to the two groups ("Deeper Mindfulness" vs "Control").

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：

由于干预措施的性质，无法对参与者和指导教师进行盲法处理（没有安慰剂对照）。然而，结果数据将由参与者填写的自评问卷构成，两组数据将以统一的方式收集。分析定量数据的研究人员将对分组情况不知情，以减少潜在的解释偏差。鉴于本研究侧重于自评结果且为试点性质，因此无需采取其他特殊的盲法策略。

Blinding：

Due to the nature of the intervention, blinding of participants and instructors is not possible (no placebo equivalent). However, outcome data will consist of self-report questionnaires completed by participants, and data will be collected in a uniform way for both groups. Researchers analyzing the quantitative data will be blinded to group assignments to reduce potential bias in interpretation. No special blinding strategies beyond this are deemed necessary (given the self-report outcome focus and the pilot nature).

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）：

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：

案例记录表和电子数据采集

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

Both Case Record Form and Electronic Data Capture

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：

  2026-01-28 16:00:38