Personalized Inhibitory Control Training for Compulsive Behavior Change
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OCD patients
排除标准
- •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
研究组 & 干预措施
P-CIT protocol
OCD patients who receive the P-CIT intervention.
干预措施: P-CIT protocol (Behavioral)
Placebo
OCD patients who don't receive the P-CIT intervention.
干预措施: Placebo (Behavioral)
结局指标
主要结局
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
时间窗: One week after P-CIT training starts
During tasks that require inhibition
fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control group
时间窗: One week after P-CIT training starts
During tasks that require inhibition
次要结局
- Behavioural- Y-bocs (Yale-Brown Obsessive-Compulsive Scale) score- change in OCD symptoms in experimental group in comparison to placebo group(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(One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training)
- Behavioural- M.I.N.I (Mini-International Neuropsychiatric Interview) score- change in OCD symptoms in experimental group in comparison to placebo group(One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training)
研究者
Shahaf Leshem
Principal investigator
Hebrew University of Jerusalem