Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity of Patients in Treatment for a Substance Use Disorder or a Behavioral Addiction. A Multicenter Randomized Controlled Trial (AjusT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 8
- 主要终点
- Craving intensity (BILAN-7 jours)
研究概览
简要总结
The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.
详细描述
Addiction is one of the most prevalent psychiatric disorders in general population. In the DSM-5, substance abuse and substance dependence have been combined into a single substance use disorder and gambling disorder is now reclassified in the new substance-related and addictive disorders category. Moreover, a criterion assessing the craving has been added. The management of craving is an important focus of addiction treatment as craving is often linked to relapse. Several cues could precipitate the craving. Some of them are substance-related or gambling-related, some other are more person-specific. Recent studies have revealed that those "individual cues" are highly predictive of craving and relapse, and suggest that they are involved in addiction chronicity. The awareness of these cues and the intensity of the craving are important to tailor a better treatment adapted to the patient's need in order to prevent relapse. The aim of this study is to evaluate the efficacy of a program that includes an Individually Adjusted Therapy scale (ATI) to help the clinician to modulate the level of care regarding of the patient's risk of relapse (based on cues, intensity and frequency of the craving). The study will consist in a randomized controlled trial comparing 2 groups of participants that are seeking treatment for substance use disorder (alcohol, opiates, tobacco, cannabis, cocaine or any other substance) or behavioral addiction in an outpatient addiction clinics in France (four inclusion sites).
All the participants will be assessed with several questionnaires that evaluate the history and the severity of addiction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years old or older
- •Meet DSM-5 substance use disorder diagnosis for at least one substance (alcohol, tobacco, cannabis, opiates, cocaine or any other substance) use disorder or behavioral addiction (gambling, screens, video games, food addiction, sex addiction, compulsive purchases), currently not stabilized
- •Seek treatment for this a substance use disorder or behavioral addiction
- •Beginning (or re-initiating) multi-month outpatient care for this disorder in one of the inclusion centres.
- •Ability to identify a priority substance/behavior, as main object of treatment, in case of simultaneous treatment on several addictions
- •Beneficiary of the French Social Security system
- •Give an informed consent to participate
排除标准
- •Severe physical or psychiatric or addictologic condition that prevents an outpatient treatment
- •Severe physical or psychiatric condition that prevents to complete the assessment
- •Addictive disorder that requires several treatment for several substance use disorder simultaneously
- •Difficulty to understand and to write French
- •Could not be reachable by phone
- •Participate to another study that prevents to participate to another research
- •Person under law protection
- •Person under legal guardianship
研究组 & 干预措施
Traitment as usual adjusted on ATI information
Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.
干预措施: Weekly assessment ajusted (Procedure)
Traitment as usual
Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.
干预措施: Weekly assessment (Procedure)
结局指标
主要结局
Craving intensity (BILAN-7 jours)
时间窗: 3 month
Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up
次要结局
- Cues of each participant (QSA)(Week 1 to Week 11)
- Mini International Neuropsychiatric Interview (MINI)(Week 1 to Week 11)
- Adjusted Therapy Scale (ATI)(Week 1 to Week 11)
- Addiction Severity Index (ASI)(Week 1 to Week 11)