ENVELMIND: Effect of the Enriched Environment on the Risk of Relapse
Study Details
Study Description
Brief 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 recruted 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 consits 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 mindfullness 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interventional Group After inclusion visit (Day 1), 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. Alcoholic relapse is then evaluated at Day 10, 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).
|
| Active Comparator: Control Group After inclusion visit (Day 1), patients randomized in the control group wil received the standard of care. They will be evaluated at Day 10, at two weeks, one month and 3 months. |
Other: Standard treatment
Standard of care treatment
|
Outcome Measures
Primary Outcome Measures
- Alcoholic relapse [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any patient hospitalized at the Henri Laborit Hospital for alcohol addiction, on an opened unit for at least 48 hours;
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Woman or man aged between 18 and 65 inclusive
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Severe alcohol use disorder according to the DSM-5 classification
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Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person
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Have signed the informed consent form after receiving written information.
Exclusion Criteria:
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Disabling cognitive disorders
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Cardiological pathologies that could compromise the participation of patients, detected by an ECG.
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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
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Hypertension
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Ataxia
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Uncompensated and unstable psychiatric pathology
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Susceptibility to cyberkinetosis
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Pregnant or breastfeeding woman
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Simultaneous participation in another trial
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Any other current addiction, except addiction to tobacco and benzodiazepines
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Employee of the investigator or of the clinical study site
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Patients protected by law
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People not covered by state health insurance
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Patients who in the opinion of the investigator are unable to complete the questionnaires
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Henri Laborit | Poitiers | France | 86021 |
Sponsors and Collaborators
- Centre Hospitalier Henri Laborit
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-A01156-37