Efficacy of a Smartphone App Designed to Manage Craving and Individual Predictors of Substance Use / Addictive Behavior Among Individuals With Addictive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 274
- 试验地点
- 2
- 主要终点
- The decrease of main problematic substance use / addictive behavior
研究概览
简要总结
Test the Efficacy of a smartphone application designed to manage craving and individual predictors of substance use / addictive behavior among individuals with addictive disorders
详细描述
This translational project is the clinical application of research results from the University of Bordeaux, Sanpsy Lab, CNRS USR3413 - on individual predictors of substance use. This project will test the efficacy of a smartphone application to help subjects concerned about reducing or stopping their substance use / behavioral addiction.
This new therapeutic tool, designed by University of Bordeaux, Sanpsy Lab, CNRS USR3413 - to manage craving and individual predictors of use, will offer the possibility of an easy to-use and personalized intervention accessible to the greatest number of subjects.
Based on our previous results that supports that, for all types of addiction, craving and individual cues are a significant drive for use in people with addiction, the application tested in this study was designed to be used among people presenting various types of addiction (substance and behavioral addictions). The application will also evaluate all concurrent substance uses and addictive behaviors to identify and prevent risk of addiction transfers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
After randomization, the application will be installed on participant's smartphone (or smartphone loaned for the study).
Randomization code will unlock one of the 2 versions of the application:
- Restricted version (only EMA) for control group
- Full interventional (active) version (EMA + EMI) for experimental group
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
- •Participants requesting help for substance or behavioral addiction in one of the participating specialized addiction treatment centers, and with more than 1-month-delay before treatment admission
- •Age >= 18 years of age
- •With at least one substance or behavioral addiction (DSM-5 criteria)
- •Affiliated person or beneficiary of a social security scheme.
- •Free, informed and written consent signed by the participant and the investigator
排除标准
- •Medical, psychiatric or addiction condition that warrants immediate treatment intervention
- •Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy....)
- •Difficulty in understanding and / or writing French
- •Not familiar with the use of smartphone
- •Individuals participating in another study that includes an ongoing exclusion period
- •Be deprived of liberty due to an ongoing legal procedure
- •Individuals under legal protection
- •Be under guardianship or under curatorship
结局指标
主要结局
The decrease of main problematic substance use / addictive behavior
时间窗: 4 weeks
We will compare the percentage of participants for whom a 20% decrease in main problematic substance use / addictive behavior was observed between 1st week and 4 th week of smartphone application use in the experimental group versus the control group
次要结局
- Feasibility of the smartphone application as assessed by use of the app (EMA responses) and drop-out rates(at 1-month)
- Temporal evolution of craving and substance use/addictive behaviors The evolution and temporal trajectories of craving intensity, substances use/addictive behaviors measured with EMA in daily life(4 weeks)
- Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction,(At 1-month and 4-month follow-up)
- Factors associated with application efficacy among initial addiction severity (ASI), initial craving for primary addiction, type of primary addiction, comorbid psychiatric disorders (MINI), and addiction treatment (ASI and TSR)(inclusion)
- Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS(at 1-mont)
- Impact on subsequent standard treatment at 4-month follow -up(at 4-month follow-up)