跳至主要内容
临床试验/NCT07690423
NCT07690423尚未招募不适用

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

Centre Hospitalier Esquirol0 个研究点目标入组 128 人开始时间: 2026年7月8日最近更新:
适应症

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

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

发起方
Centre Hospitalier Esquirol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anne-Laure VIREVIALLE

Principal Investigator

Centre Hospitalier Esquirol

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