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Completed

NCT Number: NCT05577741

Effect of the Enriched Environment on the Risk of Relapse

This clinical study investigates the effects of enriched environment on the risk of relapse in alcoholic patients.

135 patients hospitalized for an alcoholic addiction will be recruited and randomized in two groups: one group will receive standard of care, the other group will receive a treatment with enriched environment.

The enriched environment consists of six sessions of virtual reality (20 minutes) in a multi-sensory pod and six sessions (20 minutes) of bike activity with cognitive tasks while pedalling.

The multi-sensory virtual reality pod allows mindfulness practice and allows patients to be in immersive situations that may trigger cues in order to help them in craving management.

The bike consists in the combination of a pedal set and a touch pad on which cognitive training games are offered. This tool thus makes it possible to simultaneously stimulate motor skills and cognition by means of bicycle-game coupling.

Patients are then followed during 3 months and a half.

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Key information

Conditions

Alcoholic Relapse

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient hospitalized at the Henri Laborit Hospital for alcohol addiction, on an opened unit for at least 48 hours;
  • Woman or man aged between 18 and 65 inclusive
  • Severe alcohol use disorder according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders
  • Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person
  • Have signed the informed consent form after receiving written information.

Exclusion criteria

  • Disabling cognitive disorders
  • Cardiological pathologies that could compromise the participation of patients, detected by an ECG.
  • Advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor
  • Hypertension
  • Ataxia
  • Uncompensated and unstable psychiatric pathology
  • Susceptibility to cybersickness
  • Pregnant or breastfeeding woman
  • Simultaneous participation in another trial
  • Any other current addiction, except addiction to tobacco and benzodiazepines
  • Employee of the investigator or of the clinical study site
  • Patients protected by law
  • People not covered by state health insurance
  • Patients who in the opinion of the investigator are unable to complete the questionnaires

Treatment and study plan

Multisensory virtual reality pod (SENSIKS©)

Behavioral

Six sessions of 20 minutes of mindfulness.

Cognitive bike (Vélo-cognitif®)

Behavioral

Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).

standard treatment

Other

Standard of care treatment

Primary outcomes

  1. Alcoholic relapse

    Time frame: 2 weeks

    Relapse at 2 weeks (after Day 10), defined by the consumption of at least 5 glasses per occasion, or by consumption at least 5 times a week, assessed by the Time Line Follow Back, a beathalyser or a significant increase in Carbohydrate Deficient Transferrin and Gamma-GT.

    We will consider a relapse to have occurred if at least one of the three indicators points to a relapse: 1) if in the TLFB the patient indicates consumption of at least 5 times per week or at least 5 drinks per occasion; 2) if there is a significant increase in CDT and GGT since the D10 blood test, and 3) If the breathalyser is positive. We will consider patients as non-relapsers if none of these indicators (TLFB, CDT and GGT, breathalyzer) is positive.

Secondary outcomes

  1. Alcoholic relapse

    Time frame: 1 month

    Relapse at 1 month (after Day 10), defined by the consumption of at least 5 glasses per occasion, or by consumption at least 5 times a week

  2. Alcoholic relapse

    Time frame: 3 months

    Relapse at 3 months (after Day 10), defined by the consumption of at least 5 glasses per occasion, or by consumption at least 5 times a week

  3. Explicit craving

    Time frame: Day 10

    The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol.

  4. Implicit craving

    Time frame: Day 10

    The effect of intervention on implicit craving, assessed by an Implicit Association Test, a test of the seeking for alcohol-related stimuli, and a visual research test for alcohol-related stimuli (eye-tracking)

  5. Mindfulness skills

    Time frame: Day 10

    The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15)

  6. Perception of the richness of the daily environment

    Time frame: Day 10

    The effect of the intervention on the perceived richness of the daily environment, assessed by a questionnaire.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Registry information

Official study title

Effect of the Enriched Environment on the Risk of Relapse: Clinical Study Combining Physical Activity With Mindfulness in Virtual Reality

Acronym: ENVELMIND

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2022
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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