Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal: Protocol for the TUA-VelCo Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 主要终点
- proportion of participants maintaining abstinence at M1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
proportion of participants maintaining abstinence at M1
时间窗: From enrollment to the end of the treatment at 4 weeks
次要结局
未报告次要终点
研究者
Dr Anne-Laure VIREVIALLE
Principal Investigator
Centre Hospitalier Esquirol
