Alcoholic RelapseENVELMINDNCT05577741
Effect of the Enriched Environment on the Risk of Relapse
A study testing Multisensory virtual reality pod (SENSIKS©), Cognitive bike (Vélo-cognitif®) and Standard treatment in people with Alcoholic Relapse, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholic Relapse
- What is being tested?
- Multisensory virtual reality pod (SENSIKS©), Cognitive bike (Vélo-cognitif®) and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2022to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Alcoholic Relapse
- Being tested
- Multisensory virtual reality pod (SENSIKS©), Cognitive bike (Vélo-cognitif®), Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory virtual reality pod (SENSIKS©)Behavioural
Six sessions of 20 minutes of mindfulness.
Cognitive bike (Vélo-cognitif®)Behavioural
Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).
Standard treatmentOther
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | 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. Receives: Behavioral: Multisensory virtual reality pod (SENSIKS©); Behavioral: Cognitive bike (Vélo-cognitif®); Other: Standard treatment |
| Control Group | Active comparator | 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. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 3 months
Explicit craving
The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol.
Measured: 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)
Measured: Day 10
Mindfulness skills
The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15)
Measured: 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.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start29 Nov 2022
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577741
- Sponsor's protocol ID
- 2022-A01156-37
- Acronym
- ENVELMIND
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2022
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 37173113
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Enriched Environment on the Risk of Relapse: Clinical Study Combining Physical Activity With Mindfulness in Virtual Reality
- ClinicalTrials.gov ID
- NCT05577741
- Acronym / sponsor ID
- ENVELMIND / 2022-A01156-37
- Conditions
- Alcoholic Relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Multisensory virtual reality pod (SENSIKS©), Behavioral: Cognitive bike (Vélo-cognitif®), Other: Standard treatmentPatients 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. |
| Control Group | Active comparator | Other: Standard treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory virtual reality pod (SENSIKS©)Six sessions of 20 minutes of mindfulness. | Behavioural | Interventional Group |
| Cognitive bike (Vélo-cognitif®)Six sessions of 20 minutes of cognitive bike (pedal + cognitive games). | Behavioural | Interventional Group |
| Standard treatmentStandard of care treatment | Other | Control Group, Interventional Group |
Primary outcome
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.
6 secondary outcomes
Alcoholic relapse
Time frame: 1 month
Alcoholic relapse
Time frame: 3 months
Explicit craving
Time frame: Day 10
Implicit craving
Time frame: Day 10
Mindfulness skills
Time frame: Day 10
Perception of the richness of the daily environment
Time frame: Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 37173113Barillot 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory virtual reality pod (SENSIKS©), Cognitive bike (Vélo-cognitif®) and Standard treatment in people with Alcoholic Relapse, run by Centre Hospitalier Henri Laborit at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcoholic relapse (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05577741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.