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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multisensory virtual reality pod (SENSIKS©) | Behavioral | Six sessions of 20 minutes of mindfulness. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Henri Laborit | Poitiers | 86021 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37173113 | Derived | 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. |
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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.
Beginning 9 months following article publication (no end date)
Researchers upon reasonable request
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| Cognitive bike (Vélo-cognitif®) | Behavioral | Six sessions of 20 minutes of cognitive bike (pedal + cognitive games). |
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| Standard treatment | Other | Standard of care treatment |
|
| 3 months |
| Explicit craving | The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol. | 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) | Day 10 |
| Mindfulness skills | The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15) | 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. | Day 10 |