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Effect of the Enriched Environment on the Risk of Relapse (ENVELMIND)

Primary Purpose

Alcoholic Relapse

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multisensory virtual reality pod (SENSIKS©)
Cognitive bike (Vélo-cognitif®)
Standard treatment
Sponsored by
Centre Hospitalier Henri Laborit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Relapse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 DSM-5 classification
  • 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 cyberkinetosis
  • 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

Sites / Locations

  • Centre Hospitalier Henri LaboritRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Explicit craving
The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol.
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)
Mindfulness skills
The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15)
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.

Full Information

First Posted
October 10, 2022
Last Updated
March 10, 2023
Sponsor
Centre Hospitalier Henri Laborit
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1. Study Identification

Unique Protocol Identification Number
NCT05577741
Brief Title
Effect of the Enriched Environment on the Risk of Relapse
Acronym
ENVELMIND
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multisensory virtual reality pod (SENSIKS©)
Intervention Description
Six sessions of 20 minutes of mindfulness.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive bike (Vélo-cognitif®)
Intervention Description
Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).
Intervention Type
Other
Intervention Name(s)
Standard treatment
Intervention Description
Standard of care treatment
Primary Outcome Measure Information:
Title
Alcoholic relapse
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Alcoholic relapse
Description
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
Time Frame
1 month
Title
Alcoholic relapse
Description
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
Time Frame
3 months
Title
Explicit craving
Description
The effect of intervention on explicit craving, assessed by the Obsessive Compulsive Drinking Scale and the cue craving induction protocol.
Time Frame
Day 10
Title
Implicit craving
Description
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)
Time Frame
Day 10
Title
Mindfulness skills
Description
The effect of intervention on mindfulness skills, assessed by a questionnaire (Five Facets Mindfulness Questionnaire -15)
Time Frame
Day 10
Title
Perception of the richness of the daily environment
Description
The effect of the intervention on the perceived richness of the daily environment, assessed by a questionnaire.
Time Frame
Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nematollah JAAFARI, Professor
Phone
0033(0)5 16 52 61 18
Email
nemat.jaafari@ch-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nemat Jaafari, Pr
Email
nemat.jaafari@ch-poitiers.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 9 months following article publication (no end date)
IPD Sharing Access Criteria
Researchers upon reasonable request

Learn more about this trial

Effect of the Enriched Environment on the Risk of Relapse

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