Randomized Clinical Trial (RCT) for the Improvement of Cocaine Use Disorder Treatment Through the Implementation of a Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Treatment retention
研究概览
简要总结
Addictions are among the most serious and expensive public health problems in Europe and Spain and they present high morbimortality. There is an increasing amount of studies emphasizing the role e-health for improving current treatments in mental health but research in addictions is still scarce. Over the last years, there have been several indicators that show an upward trend in the consumption of cocaine and the highly treatment-resistant patients.
Objectives: 1) To evaluate whether adding a web-based cognitive behavioral therapy (CBT4CBT) to standard cocaine use disorder treatment improves treatment outcomes in a Spanish sample of patients with severe addiction 2) To explore differences between men and women in treatment response and psychopathological risk factors of treatment response. Design: Randomized clinical trial. Selection criteria: patients consecutively admitted to the inpatient treatment unit for cocaine detoxification and meet inclusion criteria. Sample: the total sample will be of 70 individuals (randomly assigned to TAU + web-based CBT4CBT (n=35) or to TAU (n=35)). Assessment: Patients will be assessed at the beginning and during inpatient treatment, before and during outpatient treatment (CBT4CBT or TAU), after outpatient treatment (CBT4CBT or TAU) and at follow ups. Treatment retention, changes on craving and related psychological variables as well as presence of benzoylecgonine in urine will be evaluated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inpatients for cocaine detoxification in our addiction unit who live in Barcelona or surroundings
- •abstinent at the time of the study assessment (from the third day of hospitalization)
- •18 years of age or older.
排除标准
- •indication of treatment for reasons other than cocaine detoxification,
- •presence of serious psychopathological or neuropsychological alterations that hinder the participation in the study (including severe intoxication)
- •opioid abuse or dependence during the last year (this criteria includes maintenance treatment with methadone or another opioid substance)
- •a lack of Spanish or Catalan knowledge or difficulties to read or write that hamper the participation in the study,
- •Non-acceptance of the study procedures, such as the signing of informed consent.
结局指标
主要结局
Treatment retention
时间窗: At 6 months follow-up after completing Arm 1 or 2
Change from baseline treatment retention versus drop out at 6 months after treatment at follow-up time point.
Relapse
时间窗: At 6 months follow-up after Arm 1 or 2
5. Change from baseline at 6 months after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up timepoint.
次要结局
- Psychopathology, dependence and craving, as well as anthropometric measures(At 6 months follow-up after Arm 1 or 2 completion)
- Addictive behaviors(Once the 8-week outpatient treatment is completed)
- Personality and emotion regulation(Once the 8-week outpatient treatment is completed)