Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06104176

Effectiveness of Virtual Reality Therapy with Cognitive Behavioral Therapy in Alcohol Use Disorder: A Multicenter Randomized Study

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-08

156

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of virtual reality exposure therapy (VRET) combined with cognitive behavioral therapy (CBT) compared to CBT alone for adults with Alcohol Use Disorder (AUD). The study aims to see if this combination reduces alcohol consumption and craving 8 months after starting treatment. Participants must be abstinent for at least 15 days and diagnosed with AUD according to DSM-V criteria. The study will be conducted at four addiction day hospitals with follow-up lasting 8 months. All participants will first receive 4 weekly group CBT sessions during the first month after joining the study. Then, they will be randomly assigned to two groups: one receiving 4 weekly individual CBT sessions, and the other receiving 4 weekly VRET sessions during the second month. Each VRET session lasts 60 to 90 minutes and includes exposure to four different virtual environments, such as home, metro advertising, party, and supermarket settings, arranged by difficulty. Participants will be followed monthly for 6 months after the treatment period. During follow-up, researchers will track the participants' alcohol intake using the Timeline Follow-Back method and assess craving with the Transaddiction Craving Triggers Questionnaire. The main outcome measured is the cumulative number of standard alcohol drinks consumed monthly up to 8 months after inclusion. Safety and continued abstinence will also be monitored throughout the study.

CONDITIONS

Official Title

Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 or over, and under 80 on the date of inclusion
  • Diagnosed with Alcohol Use Disorder according to DSM-V criteria
  • Abstinent from alcohol for at least 15 days
  • Able to speak, understand, and read French
  • Signed an informed consent
  • Affiliated with the French health insurance scheme
Not Eligible

You will not qualify if you...

  • Under major legal protection or deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding women
  • Decompensated psychiatric disorders such as psychotic, mood, or anxiety disorders
  • Alcohol Use Disorder relapse
  • Severe cognitive impairment (MOCA score 10 or less)
  • Visual impairment
  • Contraindications to virtual reality exposure including photosensitive epilepsy, balance disorders, recent stroke less than 3 months old, current nausea/vomiting, claustrophobia, medium or high myopia beyond -3.5 diopters
  • Wearing pacemaker, implanted defibrillator, or implanted hearing aids
  • Participation in another trial or in exclusion period following previous research
  • Not affiliated to the French health insurance scheme and receiving State Medical Aid

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Albert Chenevier

Créteil, Île-de-France Region, France, 94000

Actively Recruiting

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Research Team

E

El-Hadi ZERDAZI, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Study on the efficiency of virtual reality in the treatment of alcohol use disorder: study protocol for a randomized controlled trial : E-Reva.

Fanny Nègre, Maud Lemercier-Dugarin, Romain Gomet...

https://pubmed.ncbi.nlm.nih.gov/38937776