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初级医护执行的太极拳改良网络版 CBTi 对社区失眠者的疗效探讨： 开放、随机对照研究

注册号：

Registration number：

ITMCTR2024000667

最近更新日期：

Date of Last Refreshed on：

2024-11-06

注册时间：

Date of Registration：

2024-11-06

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

初级医护执行的太极拳改良网络版 CBTi 对社区失眠者的疗效探讨： 开放、随机对照研究

Public title：

Modified web-based version of tai chi performed by primary care physicians CBTi An exploration of the efficacy of CBTi in community-based insomniacs: An open, randomized controlled study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

初级医护执行的太极拳改良网络版 CBTi 对社区失眠者的疗效探讨： 开放、随机对照研究

Scientific title：

Modified web-based version of tai chi performed by primary care physicians CBTi An exploration of the efficacy of CBTi in community-based insomniacs: An open, randomized controlled study

研究课题的正式科学名称简写：

Scientific title acronym：

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：

王若愚

研究负责人：

刘恩益

Applicant：

Ruoyu Wan

Study leader：

Enyi Liu

申请注册联系人电话：

Applicant telephone：

15776633097

研究负责人电话：

Study leader's telephone：

18819810075

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：

15776633097@163.com

研究负责人电子邮件：

Study leader's E-mail：

ley1981@126.com

申请单位网址(自愿提供)：

Study leader's 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：

广东省广州市天河区天坤三路95号

研究负责人通讯地址：

广东省广州市天河区天坤三路95号

Applicant address：

No.95 Tiankun 3rd Road Tianhe District Guangzhou City Guangdong Province China

Study leader's address：

No.95 Tiankun 3rd Road Tianhe District Guangzhou City Guangdong Province China

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：

广州医科大学附属中医医院

Applicant's institution：

The Affiliated Traditional Chinese Medicine Hospital Guangzhou Medical University

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2024NK008

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

广州医科大学附属中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Chinese Medicine Hospital of Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024/1/15 0:00:00

伦理委员会联系人：

李若薇

Contact Name of the ethic committee：

Ruowei Li

伦理委员会联系地址：

广东省广州市天河区天坤三路95号

Contact Address of the ethic committee：

No.95 Tiankun 3rd Road Tianhe District Guangzhou City Guangdong Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

020-81222775

伦理委员会联系人邮箱：

Contact email of the ethic committee：

gzyiwuke@163.com

研究实施负责（组长）单位：

广州医科大学附属中医医院

Primary sponsor：

The Affiliated Traditional Chinese Medicine Hospital Guangzhou Medical University

研究实施负责（组长）单位地址：

广东省广州市天河区天坤三路95号

Primary sponsor's address：

No.95 Tiankun 3rd Road Tianhe District Guangzhou City Guangdong Province China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省广州市

市(区县)：

Country：

China

Province：

Guangzhou Guangdong Province

City：

单位(医院)：

广州医科大学附属中医医院

具体地址：

广东省广州市天河区天坤三路95号

Institution
hospital：

The Affiliated Traditional Chinese Medicine Hospital Guangzhou Medical University

Address：

No.95 Tiankun 3rd Road Tianhe District Guangzhou City Guangdong Province China

经费或物资来源：

广州医科大学科研能力提升计划重大临床研究项目

Source(s) of funding：

Major Clinical Research Project of Guangzhou Medical University Research Capacity Enhancement Program

研究疾病：

失眠

研究疾病代码：

Target disease：

insomnia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

1. 通过在社区招募失眠受试者，为大量失眠患者尤其不接受药物治疗、且因 为各种原因未能就诊的患者探索一种接受度高、可及时获取、可由初级医 护人员操作的、经济的失眠治疗方案：太极拳改良网络版 CBTi，并证实其 有效性； 2. 通过部分治疗者的一般资料收集、量表评估、睡眠手表监测数据、磁共振 数据采集探讨太极拳改良网络版 CBTi 治疗失眠疗效的影响因素和机制。

Objectives of Study：

1. To explore the feasibility of a highly acceptable, timely, and accessible primary care treatment for a large number of patients with insomnia, especially those who do not receive medication and are unable to seek medical attention for various reasons, by recruiting insomnia subjects in the community. To explore an affordable insomnia treatment program for a large number of insomnia patients, especially those who do not receive medication and are unable to seek medical treatment for various reasons: the Tai Chi Modified Network Version of CBTi. To explore a highly acceptable, timely accessible, affordable insomnia treatment program for a large number of insomnia patients, especially those who do not receive medication and cannot be seen for various reasons, that can be administered by primary healthcare professionals: the modified web-based version of tai chi chuan (CBTi), and to prove its effectiveness; 2. To explore the effectiveness of the Tai Chi Chuan Modified Network version of CBTi through general data collection, scale assessment, sleep watch monitoring data, magnetic resonance imaging (MRI) data collection from selected patients. To investigate the factors and mechanisms influencing the efficacy of Taijiquan Modified Network CBTi in the treatment of insomnia through general data collection, scale assessment, sleep watch monitoring data, and magnetic resonance data collection in some of the treated patients.

药物成份或治疗方案详述：

中医改良网络版 CBTi 组：将 CBTi 整体内容调整为中西医结合的模式，即睡眠卫生教育、刺激控制、睡眠限制、陈氏太极拳和呼吸放松练习，并且陈氏太极拳与呼吸放松从“睡眠卫生教育”便开始进行训练。具体操作过程如下： A. 陈氏太极拳和呼吸放松练习入组前，科室所有成员均经熟练太极拳的运动员进行培训太极拳和太极拳呼吸要领。入组时为受试者讲解和介绍太极拳和太极拳呼吸练习对身体放松和睡眠的影响，并介绍陈氏太极拳十八式练习过程：太极起势、金刚捣碓、懒扎衣、六封四闭、单鞭、白鹅亮翅、斜行、搂膝、拗步、掩手肱拳、高探马、左蹬一跟、玉女穿梭、云手、转身双摆莲、当头炮、金刚捣碓、收势。所有研究组受试者，入组第一天始，每天睡前 1-2 小时开始练习太极拳和呼吸训练 15-20 分钟。 B. 睡眠卫生教育 改善不良睡眠习惯，营造舒适的睡眠环境，具体内容包括： a) 午饭后避免喝咖啡，睡前 6 小时内不喝酒； b) 夜间特别是接近睡眠时避免吸烟； c) 睡前 3 小时可以进行温和的体育锻炼，但避免剧烈锻炼； d) 睡前不看连续剧、小说，禁止打麻将、扑克或者其他易引起兴奋的游戏；睡前避免摄入过多液体和过多食物； e) 保持卧室环境安静、整洁、舒适以及适宜的光线及温度。 C. 刺激控制 重建床与睡眠的联系，缩短入睡所需时间。其内容包括： a) 重建睡意与床之间的积极联系，将卧床仅仅当作睡觉与性生活的地方； b) 只有晚上有睡意或者到了规定的睡眠时间时，才上床休息； c) 如果卧床后感觉到大约 20 分钟内无法入睡时（无需看表），应离开卧室，进行一些放松活动，直到感觉有睡意再返回卧室睡觉；如果有必要，整晚都可重复该过程； d) 无论前一天晚上的睡眠时间多少，第二天早晨都在同一时间起床（包括周末），能帮助建立“生物钟”。 D. 睡眠限制 逐步稳固睡眠，让睡眠更连续。其内容包括： a) 减少卧床时间以使其和实际睡眠时间相符，但不能小于 5 小时； b) 只有睡眠效率超过 85%的情况下才可增加 15~20 分钟的卧床时间；睡眠效率＝总睡眠时间/在床上时间×100%）当睡眠效率低于 80%时则减少 15~20 分钟卧床时间;睡眠效率在 80%~85%之间，卧床时间不变; c) 避免日间小睡，并保持起床时间规律。 E. 睡眠日记：在网络版 CBTi 程序中建立睡眠日记，每日推送给受试者记录睡眠日记：睡眠时间、觉醒次数、在床时间、睡眠潜伏期。 对照组：睡眠教育组在入组时进行和 CBTi 相同的睡眠卫生教育，并发放睡眠卫生教育的宣传手册。另外同样每日推送网络版睡眠日记记录手册给睡眠教育组受试者进行记录。同时为予以相同时长助眠药物唑吡坦（可以助眠的最小剂量，最大剂量不超过 10mg/d）

Description for medicine or protocol of treatment in detail：

Traditional Chinese Medicine Improvement Network Version CBTi Group: The overall content of CBTi has been adjusted to a model that combines traditional Chinese and Western medicine including sleep hygiene education stimulation control sleep restriction Chen's Tai Chi and breathing relaxation exercises. Chen's Tai Chi and breathing relaxation are trained starting from "sleep hygiene education". The specific operation process is as follows: A. Before joining the Chen's Tai Chi and breathing relaxation practice group all members of the department received training in Tai Chi and breathing techniques from proficient Tai Chi athletes. At the time of enrollment explain and introduce the effects of Tai Chi and Tai Chi breathing exercises on physical relaxation and sleep to the subjects and introduce the 18 exercises of Chen's Tai Chi: Tai Chi rising Diamond pounding Laziness tying clothes Six seals and Four closures Single whip White Goose wings shining Diagonal movement Knee hugging Stubborn steps Hand covering Brachial Fist High pitched Horse Left kick one heel Jade Maiden shuttle Cloud hand Turning around Double Lotus Head Cannon Diamond pounding and Closing. All participants in the study group started practicing Tai Chi and breathing training for 15-20 minutes 1-2 hours before bedtime on the first day of enrollment. B. Sleep hygiene education improves unhealthy sleep habits and creates a comfortable sleeping environment including: a) Avoid drinking coffee after lunch and refrain from drinking alcohol within 6 hours before bedtime; b) Avoid smoking at night especially near sleep; c) Moderate physical exercise can be done 3 hours before bedtime but avoid vigorous exercise; d) Do not watch TV dramas or novels before bedtime and prohibit playing mahjong poker or other games that can easily cause excitement; Avoid consuming too much liquid and food before bedtime; e) Maintain a quiet tidy comfortable bedroom environment with appropriate lighting and temperature. C. Stimulus control reconstructs the connection between bed and sleep shortening the time required to fall asleep. Its content includes: a) Rebuilding the positive connection between drowsiness and bed treating bed rest only as a place for sleeping and sexual activity; b) Only go to bed and rest when you feel sleepy at night or when the designated sleep time is reached; c) If you feel unable to fall asleep for about 20 minutes after lying in bed (without looking at your watch) you should leave the bedroom and engage in some relaxation activities until you feel sleepy before returning to the bedroom to sleep; If necessary the process can be repeated throughout the night; d) Waking up at the same time the next morning (including weekends) regardless of the amount of sleep the night before can help establish a 'biological clock'. D. Sleep restriction gradually stabilizes sleep and makes sleep more continuous. Its content includes: a) Reduce bed rest time to match actual sleep time but not less than 5 hours; b) Only when sleep efficiency exceeds 85% can bed rest time be increased by 15-20 minutes; Sleep efficiency=total sleep time/time in bed × 100%) When sleep efficiency is below 80% reduce bed rest time by 15-20 minutes; Sleep efficiency is between 80% and 85% and bed rest time remains unchanged; c) Avoid daytime napping and maintain a regular wake-up time. E. Sleep Diary: Establish a sleep diary in the online version of the CBTi program and push it to participants daily to record sleep diary: sleep time number of awakenings time in bed and sleep latency. Control group: The sleep education group received the same sleep hygiene education as CBTi at the time of enrollment and was given a sleep hygiene education brochure. In addition the online version of the sleep diary recording manual is also pushed daily to the sleep education group participants for recording. At the same time to administer the same duration sleep aid drug zolpidem (the minimum dose that can aid sleep with a maximum dose not exceeding 10mg/d)

纳入标准：

A. 18 岁≦年龄≦70 岁； B. 符合 DSM-5 中“失眠障碍”诊断标准； C. 符合失眠严重指数（Insomnia Severity Index，ISI）≥8 分； D. 读写功能正常，能够正常沟通； E. 能够完成各监测时间点的评估和完成连续 6 周的改良版 CBTi 干预； F. 研究对象自愿参与本次研究并签署知情同意书。

Inclusion criteria

A. 18 years ≦ age ≦ 70 years; B. Meet the diagnostic criteria of “Insomnia Disorder” in DSM-5; C. Meets the Insomnia Severity Index (ISI) ≥ 8 points; D. Normal reading and writing function, able to communicate normally; E. Able to complete the assessments at each monitoring time point and complete the modified CBTi intervention for 6 consecutive weeks; F. Participants volunteered to participate in the study and signed an informed consent form.

排除标准：

A. 存在精神活性物质滥用或依赖史或者符合除 DSM-5 中失眠障碍外其他 精神障碍、睡眠-觉醒障碍的诊断标准； B. 有癫痫、痴呆、轻度认知障碍等神经系统疾病或者其他影响研究过程 的重大躯体疾病及颅脑外伤史； C. 由于器质性病变引起的情绪障碍、精神障碍等其他精神病史者； D. 存在磁共振检查禁忌症的禁忌症，如幽闭恐惧症、体内有金属植入物 等； E. 怀孕或者计划未来 6 个月内怀孕，或者产后 1 个月； F. 目前或者未来 6 个月内从事早晚倒班、夜班工作的； G. 已经在使用药物、系统心理治疗或者网络版辅助方法治疗失眠的参与 者。

Exclusion criteria：

A. Has a history of psychoactive substance abuse or dependence or meets the diagnostic criteria for a psychotic disorder sleep-wake disorder or other disorder other than insomnia disorder in DSM-5. Psychotic Disorders Sleep-Wake Disorders diagnostic criteria; B. History of neurological disorders such as epilepsy dementia mild cognitive impairment or other significant physical illnesses and craniocerebral trauma that would interfere with the course of the study. history of major physical illness and craniocerebral trauma; C. History of other psychiatric disorders such as mood disorders and psychotic disorders due to organic pathology; D. Contraindications to MRI such as claustrophobia metal implants in the body etc.. etc; E. Pregnant or planning to become pregnant within the next 6 months or 1 month after delivery; F. Currently or within the next 6 months working in morning and evening shifts night shifts; G. Participants who are already using medication systemic psychotherapy or web-based aids to treat insomnia. G. Participants who are already using medication systemic psychotherapy or web-based aids for insomnia.

研究实施时间：

Study execute time：

从From 2024-01-01

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2024-12-01

至To      2026-06-30

干预措施：

Interventions：

组别：

对照组

样本量：

147

Group：

control group

Sample size：

干预措施：

睡眠教育组在入组时进行和 CBTi 相同的睡眠卫生教育，并发 放睡眠卫生教育的宣传手册。另外同样每日推送网络版睡眠日记记录手册给睡 眠教育组受试者进行记录。同时为予以相同时长助眠药物唑吡坦（可以助眠的 最小剂量，最大剂量不超过 10mg/d）

干预措施代码：

Intervention：

The control group received the same sleep hygiene education as CBTi, and a promotional brochure for sleep hygiene education was distributed. Daily push of the online version of the sleep diary recording manual to control group participants for recording. At the same time, to administer the same duration sleep aid drug zolpidem (the minimum dose that can aid sleep, with a maximum dose not exceeding 10mg/d)

Intervention code：

组别：

中医改良网络版 CBTi 组

样本量：

147

Group：

Chinese Medicine Improvement Network Version CBTi Group

Sample size：

干预措施：

将 CBTi 整体内容调整为中西医结合的模式， 即睡眠卫生教育、刺激控制、睡眠限制、陈氏太极拳和呼吸放松练习，并且陈 氏太极拳与呼吸放松从“睡眠卫生教育”便开始进行训练

干预措施代码：

Intervention：

Adjust the overall content of CBTi to a combination of traditional Chinese and Western medicine, including sleep hygiene education, stimulation control, sleep restriction, Chen's Tai Chi, and breathing relaxation exercises. The training of Chen's Tai Chi and breathing relaxation starts from "sleep hygiene education"

Intervention code：

样本总量 Total sample size ： 294

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou

单位(医院)：

广州医科大学附属中医医院

单位级别：

三级甲等中医医院

Institution/hospital：

The Affiliated Traditional Chinese Medicine Hospital Guangzhou Medical University

Level of the institution：

evel 3A Chinese Medicine Hospital

测量指标：

Outcomes：

指标中文名：

睡眠生理数据和睡眠日记

指标类型：

次要指标

Outcome：

Sleep physiology data and sleep diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

失眠严重指数（ISI）

指标类型：

主要指标

Outcome：

Insomnia Severity Index

Type：

Primary 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问卷

指标类型：

次要指标

Outcome：

Pittsburgh sleep quality index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

静息态功能磁共振

指标类型：

次要指标

Outcome：

resting-state Functional Magnetic Resonance imaging

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

定制问卷

指标类型：

次要指标

Outcome：

Customized questionnaires

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

康奈尔医学指数

指标类型：

次要指标

Outcome：

Cornell Medical Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self-rating anxiety scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抑郁自评量表

指标类型：

次要指标

Outcome：

Self-rating depression scale

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：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 70 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机方法：本研究将采用简单随机方法，使用 SPSS.26.0 生成随机数字进行 排序的方法随机分组；分组隐匿：本研究为单中心的研究，将采用信封法 隐匿分组，在一个不透光的信封内保存随机分组方案，患者入组后按入组 顺序依次拆开信封，按照信封内的分配方案确定患者的分组情况（已修改） B. 开放标签：在签署知情同意书时告知研究参与者本研究为两组不同干预方 法的对照试验，参与者和 CBTi 的执行者均被通知采用何种方法干预，但是 CBTi 的执行者不参与数据的收集、统计和分析。

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

Randomization method: this study will be a simple randomization method using SPSS.26.0 Generating random numbers for sorting method for random grouping; group concealment: this study is a single-center study and will use the envelope method to Group concealment: This is a single-center study and the envelope method will be used to conceal the grouping. After patients are enrolled the envelope will be opened in order of enrollment and the patients will be grouped according to the allocation scheme inside the envelope (modified). B. Open labeling: Study participants were informed at the time of signing the informed consent form that the study was a controlled trial with two different intervention groups. Participants and the CBTi implementer are informed of the intervention method but the CBTi implementer is not involved in data collection statistics or analysis. The CBTi implementer is not involved in data collection statistics or analysis.

盲法：

Blinding：

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）：

2026.12.31

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

2026.12.31

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：

目前已制成CRF表；ResMan

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

CRF tables are now available;ResMan

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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