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临床试验/NCT04134949
NCT04134949Unknown不适用

Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners

Qazvin University Of Medical Sciences4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
4
主要终点
sleep hygiene behavior

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • Currently receiving psychological treatment for Insomnia
  • presence of a rapidly progressing neurological or medical disorder

研究组 & 干预措施

CBT

Experimental

consists of eight weekly treatment sessions of 45 to 60 minutes.

干预措施: Cognitive Behavior Therapy (Behavioral)

MCBT

Experimental

consists of eight weekly treatment sessions of 45 to 60 minutes.

干预措施: Mindfulness-Based Cognitive Therapy (Behavioral)

结局指标

主要结局

sleep hygiene behavior

时间窗: changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up

A self reported measure will be used with three items to measure how many days the participants had good sleep hygiene behavior.

Sleep Logs

时间窗: changes in Sleep Logs , 1 month and 6 months follow-up

Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.

Sleep Quality

时间窗: changes in sleep quality baseline , 1 month and 6 months follow-up

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

Insomnia Severity Index

时间窗: changes in insomnia baseline , 1 month and 6 months follow-up

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

次要结局

  • Perceived Stress Scale (PSS)(changes in PSS, 1 month and 6 months follow-up)
  • Hospital Anxiety and Depression Scale (HADS)(changes in HADS, 1 month and 6 months follow-up)
  • Mindful Attention Awareness Scale(changes in MAAS, 1 month and 6 months follow-up)
  • psychological well-being(changes in GHQ-12, 1 month and 6 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir H Pakpour

Associate Professor

Qazvin University Of Medical Sciences

研究点 (4)

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