Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
2019年10月21日 更新者：Amir H Pakpour、Qazvin University Of Medical Sciences
Insomnia is highly prevalent in prisoners and is a risk factor for poor mental well-being, depression, suicidality and aggression, all common concerns in this vulnerable population.
Improving sleep management options in prison offers the potential to impact positively on a number of these common risk factors.
The study aim is to asses psychological intervention for insomnia in prisons.
研究概览
研究类型
介入性
注册 (预期的)
140
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Qazvin、伊朗伊斯兰共和国、3419759811
- Qazvin University of Medical Sciences
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Qazvin、伊朗伊斯兰共和国、3419759811
- Social Determinants of Health Research Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Are at least 18 years of age
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia according to DSM-5 Insomnia Disorder
- Can speak, understand, and write in Persian
- Male
Exclusion Criteria:
- Currently receiving psychological treatment for Insomnia
- presence of a rapidly progressing neurological or medical disorder
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CBT
consists of eight weekly treatment sessions of 45 to 60 minutes.
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consists of eight weekly treatment sessions of 45 to 60 minutes.
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实验性的：MCBT
consists of eight weekly treatment sessions of 45 to 60 minutes.
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consists of eight weekly treatment sessions of 45 to 60 minutes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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sleep hygiene behavior
大体时间：changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up
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A self reported measure will be used with three items to measure how many days the participants had good sleep hygiene behavior.
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changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up
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Sleep Quality
大体时间：changes in sleep quality baseline , 1 month and 6 months follow-up
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The Pittsburgh Sleep Quality Index includes seven components of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the use of sleep medications and day time dysfunctions provide a total score of these seven components that allows us to better understand the quality and quantity of one's sleep.
The Pittsburgh Sleep Quality Index is a self-reporting instrument consisting of nine questions designed to measure the quality of sleep disorders in a period of one month.
The scale scores range from 0 to 21, with higher scores indicating poor quality of sleep and scores less than 5 considered as high quality of sleep
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changes in sleep quality baseline , 1 month and 6 months follow-up
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Insomnia Severity Index
大体时间：changes in insomnia baseline , 1 month and 6 months follow-up
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The Insomnia Severity Index is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes.
The Insomnia Severity Index assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems.
It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research.Higher scores reflecting more severe sleep problems
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changes in insomnia baseline , 1 month and 6 months follow-up
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Sleep Logs
大体时间：changes in Sleep Logs , 1 month and 6 months follow-up
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Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
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changes in Sleep Logs , 1 month and 6 months follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hospital Anxiety and Depression Scale (HADS)
大体时间：changes in HADS, 1 month and 6 months follow-up
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Hospital Anxiety and Depression Scale (HADS) questionnaire.
The HADS is a fourteen item scale.
Seven of the items relate to anxiety and seven relate to depression.
The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
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changes in HADS, 1 month and 6 months follow-up
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Perceived Stress Scale (PSS)
大体时间：changes in PSS, 1 month and 6 months follow-up
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The Perceived Stress Scale is the most widely used measure of global perceived stress, and is a robust predictor of health and disease.
The Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
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changes in PSS, 1 month and 6 months follow-up
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Mindful Attention Awareness Scale
大体时间：changes in MAAS, 1 month and 6 months follow-up
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The trait Mindful Attention Awareness Scale is a 15-item scale designed to assess a core characteristic of mindfulness.
Higher scores on the Mindful Attention Awareness Scale are associated with fewer & less intense current unpleasant & negative emotional states.
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changes in MAAS, 1 month and 6 months follow-up
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psychological well-being
大体时间：changes in GHQ-12, 1 month and 6 months follow-up
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The General Health Questionnaire (GHQ-12) is a self-administered questionnaire to screen and detect individuals with a diagnosable psychiatric disorder.
The higher the General Health Questionnaire scores, the greater the degree to which the subject may suffer from a psychiatric distress
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changes in GHQ-12, 1 month and 6 months follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年10月25日
初级完成 (预期的)
2019年12月30日
研究完成 (预期的)
2020年4月30日
研究注册日期
首次提交
2019年10月19日
首先提交符合 QC 标准的
2019年10月21日
首次发布 (实际的)
2019年10月22日
研究记录更新
最后更新发布 (实际的)
2019年10月22日
上次提交的符合 QC 标准的更新
2019年10月21日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.