Personalized Inhibitory Control Training for Compulsive Behavior Change
2018年9月25日 更新者：Shahaf Leshem、Hebrew University of Jerusalem
Obsessive-compulsive disorder (OCD) is a severe mental illness characterized by repetitive behaviors that a person feels compelled to perform.
It has been demonstrated that stimuli in the environment can trigger the compulsive urge, perpetuating the OCD cycle.
The main goal of the current proposal, which is based on exciting pilot data, is to test a novel computerized training program to create an association between OCD-related stimuli, which typically trigger the compulsive urge, and the brain system responsible for stopping.
The idea is that once this system is triggered, it will be easier for patients to stop the compulsive urge.
研究概览
研究类型
介入性
注册 (预期的)
50
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
-
-
-
Jerusalem、以色列
- 招聘中
- The Hebrew University of Jerusalem
-
接触：
- Shahaf Leshem
-
-
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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- OCD patients
Exclusion Criteria:
- Metal/ electronic device
- Under the age of 18
- Pregnant women
- Tattoos that cover over 10% of body mass
- Chronically ill patients
- Psychosis/ Bi-polar
- Substance abuse
- Sever depression
- Active suicide thoughts
- Hearing loss
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：P-CIT protocol
OCD patients who receive the P-CIT intervention.
|
Personalized inhibitory control training for one week.
|
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安慰剂比较：Placebo
OCD patients who don't receive the P-CIT intervention.
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without personalized inhibitory control training for one week.
|
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 |
|---|---|---|
|
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
大体时间：One week after P-CIT training starts
|
During tasks that require inhibition
|
One week after P-CIT training starts
|
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fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control group
大体时间：One week after P-CIT training starts
|
During tasks that require inhibition
|
One week after P-CIT training starts
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Behavioural- Y-bocs (Yale-Brown Obsessive-Compulsive Scale) score- change in OCD symptoms in experimental group in comparison to placebo group
大体时间：One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
|
Clinical assessment.
Semi-structured interview that assesses the presence and severity of obsessions and compulsions over the past week.
The 5-item Obsession Severity and Compulsion Severity subscales are summed to produce a Total Severity score.
Symptoms endorsed are rated on a scale from none (0) to extreme (5).
The 5-item Obsession Severity and Compulsion Severity subscales are summed to produce a Total Severity score.
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One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
|
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Behavioural- M.I.N.I (Mini-International Neuropsychiatric Interview) score- change in OCD symptoms in experimental group in comparison to placebo group
大体时间：One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
|
Clinical assessment.
Structural interview.
|
One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
|
|
Behavioural- OCI-R (Obsessive-Compulsive Inventory) score- change in OCD symptoms in experimental group in comparison to placebo group
大体时间：One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
|
Clinical assessment.
Cutoff score of 21 is distinguish individuals with OCD from those without anxiety disorders.
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One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
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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 (实际的)
2018年7月1日
初级完成 (预期的)
2019年7月30日
研究完成 (预期的)
2019年8月30日
研究注册日期
首次提交
2018年8月23日
首先提交符合 QC 标准的
2018年9月20日
首次发布 (实际的)
2018年9月25日
研究记录更新
最后更新发布 (实际的)
2018年9月27日
上次提交的符合 QC 标准的更新
2018年9月25日
最后验证
2018年9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.