Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Changes in brain activity associated with different types of Cognitive Behavioral Therapy Obsessive Compulsive Disorder
研究概览
简要总结
Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and compulsions are the two manifestations of this disease. Obsessions are recurrent anxious ideas, and compulsions repetitive behavior aiming to decrease this anxiety.
OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more precisely an hyperactivity of prefrontal cortex / basal ganglia loops.
Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex, anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference treatments : medication and Cognitive and Behavioral Therapy (CBT).
Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They are randomised in two groups : one proposing a "reference CBT", the other associate CBT to a new psychopedagogic task developed by the investigators team.
Clinical investigations and neuro-imagery data are collected at the main steps of therapies : before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity, patients and relatives quality of life are also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65;
- •Following Obsessive Compulsive Disorder criteria according to DSM IV(300.3 ;MINI 5.0.0);
- •OCD severity range from 20 to 30 on the Y-Brown obsessive compulsive scale;
- •Having checking symptoms;
- •Understanding and accepting the study;
- •Giving his written informed consent to the study.
排除标准
- •Claustrophobia;
- •Cerebral abnormality;
- •Chronic absenteism to CBT (more than 5 missed sessions during the whole therapy).
- •In case of exclusion of the study either decided by the patient himself or by the investigator, a debriefing is proposed by a psychologist.
结局指标
主要结局
Changes in brain activity associated with different types of Cognitive Behavioral Therapy Obsessive Compulsive Disorder
时间窗: before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later
Evaluation and comparison of changes in brain activity associated with different types of Cognitive Behavioral Therapy in patients with Obsessive Compulsive Disorder
次要结局
未报告次要终点