Effect of the Enriched Environment on the Risk of Relapse
- Conditions
- Alcoholic Relapse
- Interventions
- Behavioral: Multisensory virtual reality pod (SENSIKS©)Behavioral: Cognitive bike (Vélo-cognitif®)Other: Standard treatment
- Registration Number
- NCT05577741
- Lead Sponsor
- Centre Hospitalier Henri Laborit
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional Group Standard treatment 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. Interventional Group Cognitive bike (Vélo-cognitif®) 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. Interventional Group Multisensory virtual reality pod (SENSIKS©) 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. Control Group Standard treatment 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.
- Primary Outcome Measures
Name Time Method 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, 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.
- Secondary Outcome Measures
Name Time Method Implicit craving Day 10 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)
Perception of the richness of the daily environment Day 10 The effect of the intervention on the perceived richness of the daily environment, assessed by a questionnaire.
Explicit craving Day 10 The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol.
Mindfulness skills Day 10 The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15)
Alcoholic relapse 3 months 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
Trial Locations
- Locations (1)
Centre Hospitalier Henri Laborit
🇫🇷Poitiers, France