Web-based Alcohol- or Cocaine Specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Proportion of participants completing the follow-up visits
研究概览
简要总结
Substance misuse is one of the most common risk factors for health problems and premature death among adolescents and young adults worldwide. Although there are effective treatments for substance use disorder (SUD), there is still a need to further improve their effectiveness and make them easier to access. Early research suggests that substance-specific inhibition training, when used in addition to specialized treatment, can improve treatment outcomes. This training aims to strengthen inhibition specifically in situations with substance-related cues. The goal of this project is to offer this training for the first time in the form of a smartphone app, which is expected to increase the availability of the training. The main aim of the study is to evaluate whether this new app-based cognitive training is feasible as an add-on to the treatment of SUD in adolescents and young adults. In addition, the study will gather preliminary insights into whether the training affects drinking behavior and related brain processes. The project will be conducted as a double-blind, clinical pilot study. A total of 210 adolescents and young adults between 14 and 35 years old will be recruited from five specialized treatment centers. After the first study visit, participants will be randomly assigned to one of two groups: (1) an intervention group receiving the alcohol-specific inhibition training or (2) a control group receiving a similar alcohol-nonspecific inhibition training. During their participation, all participants will complete six short training sessions with the app. About one month later, they will complete six additional booster training sessions. This research may help develop effective, easily accessible tools to support young people with substance use disorder.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 - 35 years
- •Alcohol use disorder identification test (AUDIT) ≥ 7 or Drug Use Identification Test (DUDIT) ≥ 8
- •Currently undergoing outpatient treatment or online counselling in one of 7 specialized treatment settings
- •Sufficient German language skills
- •Informed Consent as documented by signature
- •Owner of a smartphone with internet access
排除标准
- •Other severe substance use (except nicotine and cannabis) determined by the cut-off value ≥ 25 in the drug use disorder identification test (DUDIT)
- •Current medical conditions excluding participation
- •Inability to read and understand the participant's information
- •Enrolment of the investigator, his/her family members, employees, and other dependent persons
- •Additional exclusion criteria for Electroencephalography (EEG)-substudy:
- •Current medication affecting EEG (e.g., benzodiazepines)
- •Other severe substance use determined by the cut-off value ≥ 25 in the DUDIT (except nicotine)
- •History of epilepsy
- •Cochlea implant
研究组 & 干预措施
Substance-specific inhibition training
12 sessions of substance-specific inhibition training
干预措施: Substance-specific inhibition training (Other)
Control training
12 sessions of unspecific inhibition training
干预措施: Control training (Other)
结局指标
主要结局
Proportion of participants completing the follow-up visits
时间窗: At the last assessment, approx. 16 weeks from enrolment
Proportion of participants completing the follow-up visits is another indicator of feasibility.
Number of participants successfully completing the program
时间窗: At the last assessment, approx. 16 weeks from enrollment
Number of participants successfully completing the program is one indicator of the feasibility of implementing substance-specific inhibition training in a smartphone app.
Number of participants adhering to the treatment
时间窗: From enrollment to last last training session, approx. 10 weeks
Number of participants adhering to the treatment, i.e. participating in all planned twelve training sessions, is another indicator of feasibility of implementing substance-specific inhibition training in a smartphone app.
Number of adverse events
时间窗: From enrollment to the last assessment, approx. 16 weeks
Number of adverse events is another indicator of feasibility of implementing substance-specific inhibition training in a smartphone app.
Number of participants recruited
时间窗: From enrollment to the last assessment, approx. 16 weeks
Number of participants recruited during the recruitment period in all participating clinical centers is one indicator of the feasibility of implementing substance-specific inhibition training in a smartphone app.
次要结局
- Number of heavy drinking days(At the last assessment, approx. 16 weeks from enrolment)
- Percentage of days abstinent(At the last assessment, approx. 16 weeks from enrolment)
- P3-component of event-related potentials(4-6 weeks.)
- N2-component of event-related potentials(4-6 weeks.)