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

Sponsor
Centre Hospitalier Esquirol
Study ID
NCT07690423
Status
Not Yet Recruiting

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Conditions

  • Alcohol Use Disorder (AUD)
  • Cognitive Cycling
  • Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cognitive cycling — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 8, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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)
  • No Intervention: 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

Primary Outcome Measure

proportion of participants maintaining abstinence at M1 [ Time Frame: From enrollment to the end of the treatment at 4 weeks ]

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