Clinical trial NCT05577741: Effect of the Enriched Environment on the Risk of Relapse
Official title: Effect of the Enriched Environment on the Risk of Relapse: Clinical Study Combining Physical Activity With Mindfulness in Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcoholic Relapse
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Alcoholic relapse
timeFrame: 2 weeks
Secondary outcomes:
measure: Alcoholic relapse
timeFrame: 1 month
measure: Alcoholic relapse
timeFrame: 3 months
measure: Explicit craving
timeFrame: Day 10
measure: Implicit craving
timeFrame: Day 10
measure: Mindfulness skills
timeFrame: Day 10
measure: Perception of the richness of the daily environment
timeFrame: Day 10
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References: