Alcoholic Relapse
Conditions
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.
Interventions
BEHAVIORALMultisensory virtual reality pod (SENSIKS©)
Six sessions of 20 minutes of mindfulness.
BEHAVIORALCognitive bike (Vélo-cognitif®)
Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).
OTHERStandard treatment
Standard of care treatment
Sponsors
Centre Hospitalier Henri Laborit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Alcoholic relapse | 1 month | 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 |
| Explicit craving | Day 10 | The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol. |
| 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) |
| Mindfulness skills | Day 10 | The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15) |
| 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. |
Countries
France
Outcome results
None listed