Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- cognitive flexibility
研究概览
简要总结
The aim of research is to test in a randomized clinical trial with active sessions, the efficacy of cognitive remediation therapy in children anorexia nervosa compared to a controlled group. The investigators want to confirm the efficacy of cognitive remediation treatment in children's flexibility problems.
详细描述
In this research, the investigators want to evaluate remediation cognitive therapy in anorexia nervosa compared to a controlled group (relaxation) based on different factors that testified the cognitive improvement of patients: one week after therapy, six months after and one year after.
Those factors are:
Weight, perfectionism and food symptomatology, temperament, therapeutic alliance and change motivation, clinical evolution of anorexia nervosa, self esteem, executive functions, neuropsychological performance (flexibility and central coherence).
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
- Single (Care Provider)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathology
- •DSM IV criteria of restrictive anorexia nervosa (AN- R), but not requiring amenorrhea or DSM V
- •Accepting and their parents to participate in the study ( signed consents )
- •Female supported for AN- R
- •Aged 8 to 16 years
- •Fluent French
- •Inpatients or outpatients suffering of restrictive anorexia nervosa
- •Treatments
- •Supports standard load ( family psychotherapy , dietary management , medical monitoring )
- •In case of anxiety or depression , patients may receive additional psychotropic prescription which should be mentioned in the record
- •Treatments previously followed by patients and treatments for other conditions should be described
排除标准
- •Pathology
- •Mental Retardation
- •Schizophrenia
- •Organic brain disorder ( encephalitis , degenerative brain tumor , cerebral neuro- degenerative disease , multiple sclerosis , amyotrophic lateral sclerosis, epilepsy )
- •Metabolic Pathology interfere with feeding or its regulation
- •Trouble consumption current substance
- •Severe somatic pathology , progressive or likely to be life -threatening
- •Topics The subjects are not mastering the French language will not be considered
- •Subjects or parents do not have sufficient capacity for understanding instructions and consent
- •No affiliation in social security ( beneficiary or legal )
结局指标
主要结局
cognitive flexibility
时间窗: 6 months after therapy
behavioral characteristics related to cognitive difficulties flexibility of anorexic patients, as measured in the medium term (6 months post treatment) by the score of the subscale "shift" BRIEF parent version of the scale (BRIEF-PR).
次要结局
- Weight status(6 months and one year)
- Food symptoms and perfectionism(6 months and one year)
- Neuropsychological performance in particular flexibility and central coherence(6 months and one year)
- Temperamental profile(6 months after therapy)
- Self-esteem(6 months and one year)
- Therapeutic alliance and motivation to change(6 months and one year)
- Executive functions(6 months and one year)