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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
210
Twelve sessions of substance-specific inhibition training
Twelve sessions of unspecific inhibition training
University of Bern
Bern, Switzerland
RECRUITINGNumber of participants recruited
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.
Time frame: From enrollment to the last assessment, approx. 16 weeks
Number of participants successfully completing the program
Number of participants successfully completing the program is one indicator of the feasibility of implementing substance-specific inhibition training in a smartphone app.
Time frame: At the last assessment, approx. 16 weeks from enrollment
Proportion of participants completing the follow-up visits
Proportion of participants completing the follow-up visits is another indicator of feasibility.
Time frame: At the last assessment, approx. 16 weeks from enrolment
Number of participants adhering to the treatment
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.
Time frame: From enrollment to last last training session, approx. 10 weeks
Number of adverse events
Number of adverse events is another indicator of feasibility of implementing substance-specific inhibition training in a smartphone app.
Time frame: From enrollment to the last assessment, approx. 16 weeks
Percentage of days abstinent
Percentage of days abstinent is the main secondary outcome indicating preliminary effects on consumption behavior. It is measured by the Timeline Follow-Back method at 3-month follow-up.
Time frame: At the last assessment, approx. 16 weeks from enrolment
Number of heavy drinking days
Number of heavy drinking days is another secondary outcome indicating preliminary effects on drinking behavior. It is measured by the Timeline Follow-Back method at 3-month follow-up.
Time frame: At the last assessment, approx. 16 weeks from enrolment
P3-component of event-related potentials
The P3-component of event-related potentials measured with electroencephalography (EEG) is used as a secondary outcome in the EEG- substudy to investigate whether substance-specific inhibition training modifies the neurophysiology of substance-specific inhibition
Time frame: 4-6 weeks.
N2-component of event-related potentials
The N2-component of event-related potentials measured with electroencephalography (EEG) is used as a secondary outcome in the EEG- substudy to investigate whether substance-specific inhibition training modifies the neurophysiology of substance-specific inhibition
Time frame: 4-6 weeks.
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