ChiCTR-TRC-12002535已完成Unknown
A randomized, controlled clinical trial: The effects of mindfulness-based cognitive therapy on chronic insomnia among Chinese patients in the community
Research Fund for the Control of Infectious Diseases Health and Health Services Research Fund1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2012年10月13日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Insomnia severity index and sleep diary
研究概览
简要总结
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:
- 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?
- 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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 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
入排标准
- 年龄范围
- 18 至 99（—）
- 性别
- All
入选标准
- •being 18 years of age or older;
- •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];
- •can understand Cantonese;
- •are willing to attend the mindfulness-based cognitive therapy program;
- •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
- •illiterate subjects as they will not be able to complete the meditation diary or PEC work sheet and questionnaires;
- •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);
- •presence of a progressive medical illness such as dementia that is directly related to the onset and course of insomnia;
- •screened positive for major depression, eating disorder, substance abuse or anxiety disorder using the Primary Health Questionnaire (PHQ);
- •presence of psychotic symptoms or disorder;
- •night shift work;
- •those already using cognitively behavioural therapy or are planning to start cognitive behavioural therapy.
研究组 & 干预措施
MBCT
MBCT course
结局指标
主要结局
Insomnia severity index and sleep diary
次要结局
未报告次要终点
研究者
研究点 (1)
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