Effect of the Enriched Environment on the Risk of Relapse

Alcoholic Relapse Clinical Trial

— ENVELMIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577741
• Other study ID #: 2022-A01156-37
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: February 2025

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Nematollah JAAFARI, Professor
• Phone: 0033(0)5 16 52 61 18
• Email: nemat.jaafari[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Relapse
• Recurrence

Intervention

Behavioral:
• Multisensory virtual reality pod (SENSIKS©)
Six sessions of 20 minutes of mindfulness.
• Cognitive bike (Vélo-cognitif®)
Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).

Other:
• Standard treatment
Standard of care treatment

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	3 months
Secondary	Explicit craving	The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol.	Day 10
Secondary	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
Secondary	Mindfulness skills	The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15)	Day 10
Secondary	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