ChiCTR2600115884 版本V1.0 版本创建时间2026/01/03 17:42:20 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：

 ChiCTR2600115884 

最近更新日期：

Date of Last Refreshed on：

 2026-01-03 17:42:12 

注册时间：

Date of Registration：

 2026-01-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effectiveness of acceptance-based diabetes self-management (ACT-DSM) for adults with type 2 diabetes for improving diabetes distress and glycaemic control: A randomised controlled trial

Public title：

Effectiveness of acceptance-based diabetes self-management (ACT-DSM) for adults with type 2 diabetes for improving diabetes distress and glycaemic control: A randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of acceptance-based diabetes self-management (ACT-DSM) for adults with type 2 diabetes for improving diabetes distress and glycaemic control: A randomised controlled trial

Scientific title：

Effectiveness of acceptance-based diabetes self-management (ACT-DSM) for adults with type 2 diabetes for improving diabetes distress and glycaemic control: 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：

Anna Ngan Hau Yi 

研究负责人：

Anna Ngan Hau Yi 

Applicant：

Anna Ngan Hau Yi 

Study leader：

Anna Ngan Hau Yi 

申请注册联系人电话：

Applicant telephone：

 +852 3943 4487

研究负责人电话：

Study leader's
telephone：

+852 3943 4487

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：

 annangan@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 annangan@cuhk.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：

Rm 619, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT.HK

研究负责人通讯地址：

Rm 619, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT.HK

Applicant address：

Rm 619, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT.HK

Study leader's address：

Rm 619, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT.HK

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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

 2024.534-T (renewal and original)

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：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-11-14 00:00:00

伦理委员会联系人：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

Contact Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

Primary sponsor's address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, 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)：

The Chinese University of Hong Kong

具体地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

经费或物资来源：

Health and Medical Research Funding

Source(s) of funding：

Health and Medical Research Funding

研究疾病：

Type 2 diabetes  

Target disease：

Type 2 diabetes

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

The primary objective is to determine whether the ACT-DSM programme is more effective than conventional diabetes self-management education in reducing HbA1c over 3–12 months. The secondary objective is to assess its impact on diabetes distress, self-care, self-efficacy, psychological flexibility, and other health markers from 1 week to 12 months post-intervention. This is tested in a cluster randomised controlled trial involving adults with type 2 diabetes of ≤8 years duration, suboptimal glycaemic control (HbA1c ≥7%), and moderate-to-high diabetes distress.  

Objectives of Study：

The primary objective is to determine whether the ACT-DSM programme is more effective than conventional diabetes self-management education in reducing HbA1c over 3–12 months. The secondary objective is to assess its impact on diabetes distress, self-care, self-efficacy, psychological flexibility, and other health markers from 1 week to 12 months post-intervention. This is tested in a cluster randomised controlled trial involving adults with type 2 diabetes of ≤8 years duration, suboptimal glycaemic control (HbA1c ≥7%), and moderate-to-high diabetes distress.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Hong Kong Chinese resident Aged 18–64 years Diagnosed with type 2 diabetes (T2D) for ≤8 years HbA1c >=7.0% in the past 3 months and confirmed at baseline capillary testing At least moderate diabetes distress: mean item score >2 on the Chinese Diabetes Distress Scale (CDDS-15) Able to communicate in Cantonese or Mandarin

Inclusion criteria

Hong Kong Chinese resident Aged 18–64 years Diagnosed with type 2 diabetes (T2D) for ≤8 years HbA1c >=7.0% in the past 3 months and confirmed at baseline capillary testing At least moderate diabetes distress: mean item score >2 on the Chinese Diabetes Distress Scale (CDDS-15) Able to communicate in Cantonese or Mandarin

排除标准：

Has a mental disorder such as: Major depression Psychosis Has an acute or severe medical illness Currently receiving or has recently received a psychological intervention for diabetes self-care

Exclusion criteria：

Has a mental disorder such as: Major depression Psychosis Has an acute or severe medical illness Currently receiving or has recently received a psychological intervention for diabetes self-care

研究实施时间：

Study execute time：

从 From 2026-01-02 00:00:00至 To 2026-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-03 00:00:00 至 To 2026-07-31 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 108

Group：

Intervention group

Sample size：

干预措施：

8-session ACT-DSM

干预措施代码：

Intervention：

8-session ACT-DSM

Intervention code：

组别：

Control group

样本量：

 108

Group：

Control group

Sample size：

干预措施：

4- session conventional DSM

干预措施代码：

Intervention：

4- session conventional DSM

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)：

 Lei Yuen Outpatient Clinic 

单位级别：

 Primary 

Institution
hospital：

Lei Yuen Outpatient Clinic

Level of the institution：

Primary

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Yuen Chau Kok Outpatient Clinic 

单位级别：

 Pirmary 

Institution
hospital：

Yuen Chau Kok Outpatient Clinic

Level of the institution：

Primary

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Leung Kau Kui Clinic 

单位级别：

 Primary 

Institution
hospital：

Leung Kau Kui Clinic

Level of the institution：

Primary

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Central Kowloon Health Centre 

单位级别：

 Primary 

Institution
hospital：

Central Kowloon Health Centre

Level of the institution：

Primary

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Kwun Tong Community Health Centre 

单位级别：

 Primary 

Institution
hospital：

Kwun Tong Community Health Centre

Level of the institution：

Primary

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Tseung Kwan O Jockey Club Outpatient Clinic 

单位级别：

 Primary 

Institution
hospital：

Tseung Kwan O Jockey Club Outpatient Clinic

Level of the institution：

Primary

测量指标：

Outcomes：

指标中文名：

Glycated haemoglobin (HbA1c)

指标类型：

主要指标

Outcome：

Glycated haemoglobin (HbA1c)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Chinese Diabetes Distress Scale-15 items (CDDS-15)

指标类型：

次要指标

Outcome：

Chinese Diabetes Distress Scale-15 items (CDDS-15)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Chinese version of Summary of Diabetes Self-Care Activities (C-SDSCA)

指标类型：

次要指标

Outcome：

Chinese version of Summary of Diabetes Self-Care Activities (C-SDSCA)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Chinese version of Diabetes Management Self-Efficacy Scale (C-DMSES)

指标类型：

次要指标

Outcome：

Chinese version of Diabetes Management Self-Efficacy Scale (C-DMSES)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Chinese version of Psychological Flexibility (PsyFlex)

指标类型：

次要指标

Outcome：

Chinese version of Psychological Flexibility (PsyFlex)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Body Mass Index (BMI)

指标类型：

次要指标

Outcome：

Body Mass Index (BMI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Blood lipid profile

指标类型：

次要指标

Outcome：

Blood lipid profile

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Blood pressure

指标类型：

次要指标

Outcome：

Blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

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 64 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）：

Six Hospital Authority general outpatient clinics are randomised (1:1) to ACT-DSM or control group using computer-generated random sequence by an independent statistician. The Principal Investigator (PI) and research team are not involved in generating the sequence. Allocation is concealed using sealed opaque envelopes.

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

Six Hospital Authority general outpatient clinics are randomised (1:1) to ACT-DSM or control group using computer-generated random sequence by an independent statistician. The Principal Investigator (PI) and research team are not involved in generating the sequence. Allocation is concealed using sealed opaque envelopes.

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：

Outcome assessor (RA2) is blinded to group allocation.

Blinding：

Outcome assessor (RA2) is blinded to group allocation.

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

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）：

None

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：

CRFs;EDC

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

CRFs;EDC

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：

  2026-01-03 17:42:12