【ChiCTR-TRC-12002535】A randomized, controlled clinical trial: The effects of mindfulness-based cognitive therapy on chronic insomnia among Chinese patients in the community

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基本信息

登记号

ChiCTR-TRC-12002535

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2012-09-28

临床申请受理号

靶点

适应症

Chronic Insomnia

试验通俗题目

A randomized, controlled clinical trial: The effects of mindfulness-based cognitive therapy on chronic insomnia among Chinese patients in the community

试验专业题目

A randomized, controlled clinical trial: The effects of mindfulness-based cognitive therapy on chronic insomnia among Chinese patients in the community

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

Nil

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临床试验信息

试验目的

The aim of the current proposed study is to evaluate the effectiveness of MBCT in treating primary chronic insomnia in primary care by comparison with a psycho-education control (PEC) group. The research questions are as follows: 1. Can MBCT improve sleep efficiency, sleep latency, time awake after sleep onset and total sleep time in those who suffer from chronic insomnia when compared to a psycho-education control group? 2. Is MBCT effective in reducing health service utilization in patients with chronic insomnia (including utilization of primary care services e.g. private doctor consultation, Accident and Emergency utilization and general outpatient utilization) when compared to a psycho-education control group? We hypothesize that patients who have been randomized to the MBCT group would show greater improvements on sleep latency, time awake after sleep onset, and sleep efficiency when compared to a psycho-education control group. We also hypothesize that patients in the MBCT condition would have a greater reduction in health service use than patients in the psycho-education control group.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

This generation of random numbers and assignment will be performed by a statistician who is not part

盲法

The research staff to be employed for this study includes 1 full time senior research assistant (master degree with 4 year relevant experience). He/she will also be responsible for conducting the baseline interviews, blinded assessment of patients’ health service utilization and visits to health care professionals, and blinded assessment of patient’s outcome survey

试验项目经费来源

Research Fund for the Control of Infectious Diseases Health and Health Services Research Fund

试验范围

目标入组人数

214

实际入组人数

第一例入组时间

2012-10-13

试验终止时间

2014-10-14

是否属于一致性

入选标准

1. being 18 years of age or older; 2. having, at baseline assessment, chronic insomnia based on established criteria (DSM IV and ICD-10 combined) that include: (1) difficulties initiating and/or maintaining sleep, defined as a sleep onset latency and /or wake after sleep onset greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least 3 nights per week as measured by daily sleep diaries; (2) duration of longer than 6 months and c) significant impairment of daytime functioning (rating of >=2 on item 5 of the Insomnia Severity Index [ISI]; 3. can understand Cantonese; 4. are willing to attend the mindfulness-based cognitive therapy program; 5. are willing to discontinue their sleep medications for a period of 2 weeks (washout period) prior to enrolling in the study or agree to keep constant the dosage and frequency of sleep medication during the study period among those who regularly use sleep medications.；

排除标准

1. illiterate subjects as they will not be able to complete the meditation diary or PEC work sheet and questionnaires; 2. psychiatric and medical co-morbidities that are potentially life threatening (i.e. psychosis, suicidal ideation, terminal medical illness) or conditions expected to severely limit patient participation or adherence (e.g. psychosis, current substance or alcohol abuse, dementia, pregnancy); 3. presence of a progressive medical illness such as dementia that is directly related to the onset and course of insomnia; 4. screened positive for major depression, eating disorder, substance abuse or anxiety disorder using the Primary Health Questionnaire (PHQ); 5. presence of psychotic symptoms or disorder; 6. night shift work; 7. those already using cognitively behavioural therapy or are planning to start cognitive behavioural therapy.；

研究者信息

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试验机构

JC School of Public Health and Primary Care, the Chinese University of Hong Kong

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研究负责人邮编

Nil

联系人通讯地址