App-based training for alcohol-specific control in adolescents and young adults with problematic alcohol consumption
Résumé de l'étude
Background: Alcohol abuse is one of the most common risk factors for health problems and premature deaths among adolescents and young adults worldwide. Despite the availability of effective treatments for alcohol use disorders (AUD), there is a need to enhance their effectiveness and expand accessibility. Initial research findings suggest that alcohol-specific control training – as an adjunct to specialized treatment – improves treatment outcomes. This training is designed to enhance alcohol-specific control. Project Objective: In our research project, this training will be implemented for the first time in the form of an app, increasing the availability and attractiveness of the training. The aim of the project is to evaluate the feasibility of this new app-based cognitive training as an adjunct to the treatment of AUD in adolescents and young adults. Additionally, initial insights into the effectiveness on drinking behavior and the neurophysiological effects of the training will be investigated. Procedure: The project will be conducted as a double-blind, multicenter clinical pilot study. A total of 210 adolescents and young adults aged 14 to 27 will be recruited from five specialized treatment centers. After the first appointment, participants will be randomly assigned to one of two study conditions: 1) the intervention with alcohol-specific control training or 2) a control condition that includes a non-alcohol-specific control training. During the study participation, participants will be guided through six short training sessions, followed by six booster training sessions after approximately one month.
(BASEC)
Intervention étudiée
In the alcohol-specific control training, alcohol-related and neutral images are shown in combination with a Go or No-Go cue. Participants are asked to press a button as quickly as possible when an image is displayed with a Go cue. When an image with a No-Go cue appears, participants should refrain from responding as much as possible. Alcohol-related images are specifically combined with No-Go cues, and the ratio of Go to No-Go cues is 75/25. A training session lasts approximately 10 to 15 minutes. The training is offered within an app to increase accessibility.
(BASEC)
Maladie en cours d'investigation
Alcohol use disorder
(BASEC)
Adolescents and young adults aged 14 – 27 years with alcohol problems. Participants must be involved in one of the following specialized outpatient treatment or online counseling services: in the University Psychiatric Services Bern (UPD), at the Südhang Clinic, with the Blue Cross, at Berner Gesundheit, or through Safezone.ch (BASEC)
Critères d'exclusion
Individuals with high consumption of other substances (except nicotine or cannabis) are not allowed to participate. (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
PD Dr. Maria Stein University of Bern
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. phil. Maria Stein
+41 31 684 54 12
maria.stein@clutterunibe.chUniversity of Bern
(BASEC)
Informations générales
University of Bern
+41 31 684 54 12+41 31 684 54 12
maria.stein@clutterunibe.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
20.08.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT07071779 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults with Substance Use Disorder (BASEC)
Titre académique
Web-based Alcohol-specific Inhibition Training in Adolescents and Young Adults With Alcohol Use Disorder (ICTRP)
Titre public
Web-based Alcohol-specific Inhibition Training in Adolescents and Young Adults With Alcohol Use Disorder (ICTRP)
Maladie en cours d'investigation
Alcohol Use Disorder (AUD) (ICTRP)
Intervention étudiée
Other: Alcohol-specific inhibition trainingOther: Control training (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Age 14 - 27 years
- Alcohol use disorder identification test (AUDIT) = 8
- Alcohol use disorder scale (AUD-S) = 2
- Currently undergoing outpatient treatment or online counselling in one of 5
specialized treatment settings
- Sufficient German language skills
- Informed Consent as documented by signature
- Owner of a smartphone with internet access
Exclusion Criteria:
- 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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Number of participants recruited;Number of participants successfully completing the program;Proportion of participants completing the follow-up visits;Number of participants adhering to the treatment;Number of adverse events (ICTRP)
Percentage of days abstinent;Number of heavy drinking days;P3-component of event-related potentials;N2-component of event-related potentials (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Maria Stein, PD Dr.Maria Stein, PD Dr.Maria Stein, PD Dr., maria.stein@unibe.chmaria.stein@unibe.ch, +41 31 684 54 12+41 31 684 54 12, University of Bern (ICTRP)
ID secondaires
BASEC2024-01150 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT07071779 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible