Exploring how an enriched environment affects relapse risk in alcohol addiction
Effect of the Enriched Environment on the Risk of Relapse: Clinical Study Combining Physical Activity With Mindfulness in Virtual Reality
This study is testing if adding fun activities like virtual reality and bike exercises can help people with alcohol addiction avoid relapse after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Henri Laborit Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT05577741 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the impact of an enriched environment on the risk of relapse among patients with alcohol addiction. A total of 135 hospitalized patients will be randomized into two groups: one receiving standard care and the other participating in an enriched environment treatment. This treatment includes six sessions of virtual reality in a multi-sensory pod and six sessions of cognitive tasks while pedaling on a bike. The aim is to enhance craving management through immersive experiences and cognitive stimulation. Patients will be monitored for 3.5 months following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with severe alcohol use disorder who are hospitalized for treatment.
Not a fit: Patients with severe cognitive disorders, unstable medical conditions, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of relapse in individuals recovering from alcohol addiction.
How similar studies have performed: While the specific combination of interventions is novel, similar studies exploring immersive environments for addiction treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Poitiers
- Centre Hospitalier Henri Laborit — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Nematollah JAAFARI, Professor
- Email: nemat.jaafari@ch-poitiers.fr
- Phone: 0033(0)5 16 52 61 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.