Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal

Официальное название

Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal: Protocol for the TUA-VelCo Randomised Controlled Trial

Обзор

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.

Вмешательства

• Другое cognitive cycling
  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.

Первичные конечные точки

• proportion of participants maintaining abstinence at M1 [Срок оценки: From enrollment to the end of the treatment at 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07690423 · 2025-A01438-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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