COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Normalizing the possible alterations in the endogenous cannabinoid system
研究概览
简要总结
General objective:
To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users.
Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed.
Patients will be randomly assigned to one of two treatments:
- Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment
- Control group (N=50): standard treatment: psychoeducation + pharmacological treatment
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
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Having a first psychotic episode. DSM-IV-TR diagnosis of a psychotic disorder (i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, bipolar disorder, atypical psychosis, brief psychotic disorder, or major depressive disorder with psychotic symptoms).
- •- Being a regular cannabis user according DSM-IV
- •Being in remission from the first psychotic episode (not exceeding 5 years).
排除标准
- •Presenting organic brain pathology.
- •Presenting mental retardation according to DSM-IV criteria.
结局指标
主要结局
Normalizing the possible alterations in the endogenous cannabinoid system
时间窗: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To assess whether treatment program specific for cannabis abstinence is capable of normalizing the possible alterations in the endogenous cannabinoid system in patients that reduce the cannabis use.
Changes in the components of the endogenous cannabinoid system
时间窗: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To determine whether changes in the components of the endogenous cannabinoid system at systematic level are produced in FEP cannabis abusers.
Cannabis use reduction in the follow-up
时间窗: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.
To assess whether cannabis focused psychological intervention is associated with a cannabis use reduction according to Europ-ASI scale compared to standard treatment
Improvement in the development of psychotic disorder
时间窗: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To assess whether cannabis focused psychological intervention is associated with an improvement in the development of psychotic disorder (ie, reduction of symptoms and improvement of psychosocial functioning) compared with standard treatment at the end of treatment and at follow-up (at three and six months and one year of follow-up).
次要结局
- Decrease the number of cannabis users(Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
- Improvement in the psychosocial functioning(Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
- Decrease of negative and positive psychotic symptoms(Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
- Decrease of manic, depressive and anxiety symptoms(Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
- Improvement in the adherence to pharmacological treatment(Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
- Withdrawal of patients(Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
- Decrease the number of relapses and rehospitalizations(Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
研究者
Itxaso Ortega Gonzalez
Itxsaso Gonzalez Ortega
Basque Health Service