Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal (TUA-VelCo)
Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal: Protocol for the TUA-VelCo Randomised Controlled Trial
TUA-VelCo is a single-center randomized controlled superiority trial with blinded methodological assessment. Adult patients hospitalized for alcohol withdrawal and meeting the criteria for Alcohol Use Disorder (AUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition will be eligible for inclusion. Participants will be randomly assigned to either a cognitive cycling intervention group or a control group.
Participants in the experimental group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks). The control group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions. Assessments will be conducted at baseline, 1 month (M1), and 3 months (M3) following hospital discharge.
The primary outcome will be the proportion of participants maintaining abstinence at M1. Secondary outcomes include maintenance of abstinence at M3 and within-group and between-group changes in craving, cognitive functioning, insight, psychiatric symptoms, and motivation to maintain abstinent. These outcomes will be assessed using validated scales, including the Obsessive Compulsive Drinking Scale, Montreal Cognitive Assessment, Hanil Alcohol Insight Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scale. Biomarkers related to alcohol consumption and neuroplasticity will also be evaluated.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- adults aged ≥ 18 years
- patients with a diagnosis of alcohol use disorder (AUD) according to DSM-5 criteria
- who have been hospitalized for complex withdrawal and aim to maintain abstinence after discharge
- patients must have preserved cognitive function, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 26
- patients must provide written informed consent
Exclusion Criteria:
- pregnant women
- patients with unstable psychiatric or somatic conditions
- with a contraindication to physical activity
- participants in structured rehabilitation programs during the first month
- adult under guardianship
- with inability to understand French or provide informed consent
- with major neurocognitive disorder
- with regular physical activity
- participation in another interventional study interfering with outcomes
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cognitive cycling group
Participants in the experimental (cognitive cycling) group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks)
|
Participants in the experimental group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks).
The control group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions.
Assessments will be conducted at baseline, 1 month (M1), and 3 months (M3) following hospital discharge.
|
|
Ingen indgriben: Control phone group
The control phone group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
proportion of participants maintaining abstinence at M1
Tidsramme: From enrollment to the end of the treatment at 4 weeks
|
From enrollment to the end of the treatment at 4 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-A01438-41
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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