Effect of the Enriched Environment on the Risk of Relapse (ENVELMIND)

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

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.

Study Overview

• Status: Completed
• Conditions: Alcoholic Relapse
• Intervention / Treatment: Behavioral: Multisensory virtual reality pod (SENSIKS©); Behavioral: Cognitive bike (Vélo-cognitif®); Other: Standard treatment

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Centre Hospitalier Henri Laborit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; 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©); Six sessions of 20 minutes of mindfulness.; Behavioral: Cognitive bike (Vélo-cognitif®); Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).; Other: Standard treatment; Standard of care treatment
Active Comparator: Control Group; 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; Standard of care treatment

What is the study measuring?

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
Explicit craving	The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol.	Day 10
Mindfulness skills	The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15)	Day 10
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit

Publications and helpful links

General Publications

• Barillot L, Chauvet C, Besnier M, Jaafari N, Solinas M, Chatard A. Effect of environmental enrichment on relapse rates in patients with severe alcohol use disorder: protocol for a randomised controlled trial. BMJ Open. 2023 May 12;13(5):e069249. doi: 10.1136/bmjopen-2022-069249.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): July 9, 2025
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 2022-A01156-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available (including data dictionaries) to researchers upon reasonable request, beginning 9 months following article publication (no end date). All the deidentified individual participant data collected during the trial, study protocol, statistical analysis plan, informed consent form, and analytic code will be shared. Data will be available for any purpose by writing a request to lila.barillot@uiv-poitiers.fr.
• IPD Sharing Time Frame: Beginning 9 months following article publication (no end date)
• IPD Sharing Access Criteria: Researchers upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No