NCT05577741

Effect of the Enriched Environment on the Risk of Relapse

Effect of the Enriched Environment on the Risk of Relapse: Clinical Study Combining Physical Activity With Mindfulness in Virtual Reality

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Centre Hospitalier Henri Laborit · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Relapse

Interventions

Type	Name	Description
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).
OTHER	Standard treatment	Standard of care treatment

Timeline

• Start date: 2022-11-29
• Primary completion: 2025-07-09
• Completion: 2025-07-09
• First posted: 2022-10-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: France