Effect of the Enriched Environment on the Risk of Relapse

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcoholic Relapse

Intervention / Treatment
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* Behavioral: Multisensory virtual reality pod (SENSIKS©)
* Behavioral: Cognitive bike (Vélo-cognitif®)
* Other: Standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>Patients complete a measurement session at inclusion visit (Day 1). These measures include an assessment of explicit and implicit craving, a measure of mindfulness skills and a measure of the perceived richness (in stimuli) of daily environment. After inclusion visit, patients randomized in the interventional group will have 6 sessions of enriched environment (from Day 2 to Day 9). The enriched environment includes: the multisensory virtual reality pod offers sessions of 20 minutes of mindfulness in immersive situations. Some immersive situations are relaxing and others trigger cues in order to improve craving management; the cognitive bike offers training sessions of 20 minutes. The patient pedals while using a touch pad with cognitive training games. This simultaneously stimulate motor skills and cognition by means of bicycle-game coupling. A second measurement session takes place at Day 10. Alcoholic relapse is then evaluated at two weeks, one month and 3 months. | Behavioral: Multisensory virtual reality pod (SENSIKS©)<br>* Six sessions of 20 minutes of mindfulness.<br>Behavioral: Cognitive bike (Vélo-cognitif®)<br>* Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).<br>Other: Standard treatment<br>* Standard of care treatment<br>|
| Active Comparator: Control Group<br>Patients complete a similar measurement session to the intervention arm, that include psychological tasks and questionnaires at inclusion visit (Day 1). After inclusion visit, patients randomized in the control group wil received the standard of care. A second measurement session takes place at Day 10. Alcoholic relapse is then evaluated at two weeks, one month and 3 months. | Other: Standard treatment<br>* Standard of care treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcoholic relapse | 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcoholic relapse | 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 | 1 month | 
| Alcoholic relapse | 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 months | 
| Explicit craving | The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol. | Day 10 | 
| Implicit craving | 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) | Day 10 | 
| Mindfulness skills | The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15) | Day 10 | 
| Perception of the richness of the daily environment | The effect of the intervention on the perceived richness of the daily environment, assessed by a questionnaire. | Day 10 |