App-based training for alcohol-specific control in adolescents and young adults with problematic alcohol consumption
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
Individuals with high consumption of other substances (except nicotine or cannabis) are not allowed to participate. (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
PD Dr. Maria Stein University of Bern
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. phil. Maria Stein
+41 31 684 54 12
maria.stein@clutterunibe.chUniversity of Bern
(BASEC)
Informazioni generali
University of Bern
+41 31 684 54 12+41 31 684 54 12
maria.stein@clutterunibe.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
20.08.2024
(BASEC)
ID di studio ICTRP
NCT07071779 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults with Substance Use Disorder (BASEC)
Titolo accademico
Web-based Alcohol-specific Inhibition Training in Adolescents and Young Adults With Alcohol Use Disorder (ICTRP)
Titolo pubblico
Web-based Alcohol-specific Inhibition Training in Adolescents and Young Adults With Alcohol Use Disorder (ICTRP)
Malattie studiate
Alcohol Use Disorder (AUD) (ICTRP)
Intervento studiato
Other: Alcohol-specific inhibition trainingOther: Control training (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
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 secondari
BASEC2024-01150 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07071779 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile