基于七维时间质量评估的心理健康自我管理工具开发及其干预应用研究

注册号:

Registration number:

ChiCTR2600126707 

最近更新日期:

Date of Last Refreshed on:

2026-06-14 22:02:41 

注册时间:

Date of Registration:

2026-06-14 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于七维时间质量评估的心理健康自我管理工具开发及其干预应用研究

Public title:

Development and Intervention Application of a Mental Health Self-Management Tool Based on Seven-Dimensional Time Quality Assessment

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于七维时间质量评估的心理健康自我管理工具开发及其干预应用研究

Scientific title:

Development and Intervention Application of a Mental Health Self-Management Tool Based on Seven-Dimensional Time Quality Assessment

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:

吕雨 

研究负责人:

骆宏 

Applicant:

Yu Lv 

Study leader:

Hong Luo 

申请注册联系人电话:

Applicant telephone:

+86 571 8512 3265

研究负责人电话:

Study leader's
telephone:

+86 571 8512 3265

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:

15723618449@163.com

研究负责人电子邮件:

Study leader's E-mail:

luohong@vip.126.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:

浙江省杭州市余杭区仓前街道余杭塘路2318号

研究负责人通讯地址:

浙江省杭州市西湖区天目山路305号

Applicant address:

No. 2318 Yuhangtang Road, Cangqian Subdistrict, Yuhang District, Hangzhou City, Zhejiang Province

Study leader's address:

No. 305 Tianmushan Road, Xihu District, Hangzhou City, Zhejiang 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:

杭州师范大学

Applicant's institution:

Hangzhou Normal University

研究负责人所在单位:

杭州市第七人民医院

Affiliation of the Leader:

Hangzhou Seventh People's Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

研(2026年)论审第(002)号

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:

杭州市第七人民医院伦理审查委员会

Name of the ethic committee:

Ethics Review Committee of Hangzhou Seventh People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-01-07 00:00:00

伦理委员会联系人:

张雨桐

Contact Name of the ethic committee:

Yutong Zhang

伦理委员会联系地址:

浙江省杭州市天目山路305号

Contact Address of the ethic committee:

No. 305 Tianmushan Road, Xihu District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 571 8512 3265

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:

杭州市第七人民医院

Primary sponsor:

Hangzhou Seventh People's Hospital

研究实施负责(组长)单位地址:

浙江省杭州市西湖区天目山路305号

Primary sponsor's address:

No. 305 Tianmushan Road, Xihu District, Hangzhou City, Zhejiang Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

杭州市第七人民医院

具体地址:

浙江省杭州市西湖区天目山路305号

Institution
hospital:

Hangzhou Seventh People's Hospital

Address:

No. 305 Tianmushan Road, Xihu District, Hangzhou City, Zhejiang Province

经费或物资来源:

课题组科研经费

Source(s) of funding:

Research Funding of the Research Group

研究疾病:

抑郁障碍、焦虑障碍  

Target disease:

Depressive Disorder,Anxiety Disorder

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:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

1.开发基于七维时间质量评估的心理健康自我管理工具: 在系统梳理国内外相关理论与实证研究的基础上,构建七维时间模型的概念框架,明确其结构维度与测量指标,完成工具条目编制、初步验证与修订,形成具有良好信效度的量化评估工具。 2.检验七维时间质量工具在不同人群中的心理测量学特性与适用性: 通过对青少年与成人样本进行大规模测量,分析工具的结构效度、内部一致性、重测信度及人群适配性,构建客观可靠的时间质量评估体系,为其在公共卫生和心理健康领域的应用奠定科学基础。 3.评估基于焦点解决短期治疗的七维时间质量心理干预效果: 以住院青少年患者为对象,验证焦点解决短期治疗(Solution-Focused Brief Therapy, SFBT)对七维时间质量感知及心理健康水平的改善作用。  

Objectives of Study:

1. Develop a psychological self-management tool for mental health based on seven-dimensional time quality assessment: Based on a comprehensive review of relevant theories and empirical studies both domestically and internationally, construct the conceptual framework of the seven-dimensional time model, clarify its structural dimensions and measurement indicators, complete the item compilation, preliminary validation and revision, and form a quantitative assessment tool with good reliability and validity. 2. Test the psychometric characteristics and applicability of the seven-dimensional time quality tool in different populations: Conduct large-scale measurements on adolescent and adult samples, analyze the structural validity, internal consistency, test-retest reliability and population adaptability of the tool, and construct an objective and reliable time quality assessment system, laying a scientific foundation for its application in public health and mental health fields. 3. Evaluate the effectiveness of the seven-dimensional time quality psychological intervention based on solution-focused short-term therapy: Take hospitalized adolescent patients as the subjects, verify the improvement effect of solution-focused brief therapy (SFBT) on the perception of seven-dimensional time quality and mental health levels.

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.急性精神病性发作(如精神分裂症急性期、严重幻觉/妄想、严重思维紊乱)。 2.双相情感障碍躁狂期或混合发作期。 3.严重自杀风险或持续自伤行为者。 4.有高冲动性或攻击行为,可能影响干预安全者。

Exclusion criteria:

1. Acute psychotic episodes (such as acute phase of schizophrenia, severe hallucinations/delusions, severe disordered thinking). 2. Manic or mixed episodes of bipolar disorder. 3. Individuals with a high risk of suicide or persistent self-harming behavior. 4. Those with high impulsivity or aggressive behavior that may affect the safety of the intervention.

研究实施时间:

Study execute time:

From 2026-01-01 00:00:00 To 2028-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-20 00:00:00 To 2028-06-30 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

100

Group:

Intervention Group

Sample size:

干预措施:

在常规心理干预的基础上,干预将采用焦点解决短期治疗小组辅导形式,每组约6-8名青少年,持续2周,每周3次小组会谈(必要时辅以个别短谈)。每次小组会谈时长约90分钟,流程遵循焦点解决短期治疗经典架构并结合时间感知主题,包括:破冰与近况正向回顾(约15分钟)、聚焦主题的奇迹设想(约20分钟)、挖掘成功经验与现有资源(约20分钟)、制定现实目标和行动步骤(约20分钟)、总结鼓舞与结束(约15分钟)。上诉流程每次聚会会重复,但焦点维度不同。

干预措施代码:

Intervention:

On the basis of routine psychological treatment, intervention will be delivered in the form of solution-focused brief therapy (SFBT) group counseling. Each group will consist of approximately 6–8 adolescents, lasting 2 weeks with 3 group sessions per week (supplemented by brief individual sessions when necessary). Each group session will last about 90 minutes, following the classic structure of SFBT combined with time-perception themes, including: ice-breaking and positive review of recent status (≈15 minutes), theme-focused miracle question exploration (≈20 minutes), exploration of successful experiences and existing resources (≈20 minutes), development of realistic goals and action steps (≈20 minutes), and summary and encouragement to conclude (≈15 minutes). The above process will be repeated in each session, with different focused dimensions each time.

Intervention code:

组别:

对照组

样本量:

100

Group:

Control Group

Sample size:

干预措施:

常规心理干预

干预措施代码:

Intervention:

Routine Psychological Treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

杭州市第七人民医院 

单位级别:

三甲 

Institution
hospital:

Hangzhou Seventh People's Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

七维时间质量量表

指标类型:

主要指标

Outcome:

Seven-Dimensional Time Quality Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

积极与消极情绪量表

指标类型:

次要指标

Outcome:

Positive and Negative Affect Schedul(PANAS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活满意度量表

指标类型:

次要指标

Outcome:

Satisfaction With Life Scale (SWLS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Quality Index (PSQI)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

UCLA 孤独量表

指标类型:

次要指标

Outcome:

UCLA Loneliness Scale(UCLC-LS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

同伴关系问卷

指标类型:

次要指标

Outcome:

Peer Relationship Questionnaire

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 18 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):

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

None

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:

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):

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:

CRF

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:

无/No

注册人:

Name of Registration:

 2026-06-14 22:02:34