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

Centre Hospitalier Henri Laborit

Status: Completed

Conditions: Alcoholic Relapse

Treatments: Other: Standard treatment; Behavioral: Multisensory virtual reality pod (SENSIKS©); Behavioral: Cognitive bike (Vélo-cognitif®)

Study type: Interventional

Funder types: Other

Identifiers

NCT05577741

2022-A01156-37

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

Interventional Group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive bike (Vélo-cognitif®)

Behavioral: Multisensory virtual reality pod (SENSIKS©)

Other: Standard treatment

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Standard treatment