Effect of the Enriched Environment on the Risk of Relapse

NCT ID: NCT05577741

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2025-07-09

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.

Conditions

Alcoholic Relapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional Group

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.

Group Type: EXPERIMENTAL

Multisensory virtual reality pod (SENSIKS©)

Intervention Type: BEHAVIORAL

Six sessions of 20 minutes of mindfulness.

Cognitive bike (Vélo-cognitif®)

Intervention Type: BEHAVIORAL

Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).

Standard treatment

Intervention Type: OTHER

Standard of care treatment

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: OTHER

Standard of care treatment

Interventions

Multisensory virtual reality pod (SENSIKS©)

Six sessions of 20 minutes of mindfulness.

Intervention Type: BEHAVIORAL

Cognitive bike (Vélo-cognitif®)

Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).

Intervention Type: BEHAVIORAL

Standard treatment

Standard of care treatment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Henri Laborit

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Henri Laborit

Poitiers, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37173113 (View on PubMed)

Other Identifiers

2022-A01156-37

Identifier Type: -

Identifier Source: org_study_id