Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study (e-ReVA)

Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study : a Multicenter Randomized Trial. Original Title in French : étude de l'efficacité de la Réalité Virtuelle Dans le Traitement du Trouble de l'Usage d'Alcool : un Essai randomisé Multicentrique (e-Réva)

Intro: Virtual reality exposure therapy (VRET) has been widely assessed in several mental disorders, including substances use disorders. In the case of alcohol use disorder (AUD), published studies focus mainly on craving interventions: eliciting, triggering, reduction or extinction, with promising result. However, data Virtual reality exposure therapy effect on reduction of alcohol consumption or abstinence remains scarce.

Hypothesis/Objective: The investigators hypothesis that VRET associated to cognitive behaviors therapy (CBT) will be more effective than CBT alone on the reduction in the cumulative number of standard drinks (vs) of alcohol intakes at 8 months after inclusion. The second objective is the assess its effectiveness on reported craving also at 8 months.

Method: The investigators plane to recruit 156 subjects aged 18 and over, with AUD according to DSM V criteria, abstinent for at least 15 days. Non-inclusion criteria are: AUD relapse, pregnancy or breastfeeding (for women), decompensated comorbid mental disorder, severe cognitive impairment, epilepsy or history of photo paroxysmal EEG responses, balance disorders, recent stroke less than 3 months old, current nausea/vomiting, claustrophobia, severe visual impairment, and medium or high myopia (beyond -3.5 diopters). The study recruitment and sitting will be on 4 addiction day hospitals, and the follow up period will be of 8 months.

All subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month. Afterwards, all included subjects will be followed monthly for 6 months (Months 2 to 8 after inclusion). Timeline Follow-Back (TLFB) is used for the reporting of the number of alcohol standard drinks intakes, and the Transaddiction Craving Triggers Questionnaire (TCTQ) for craving assessment.

Study Overview

• Status: Recruiting
• Conditions: Alcool Use Disorder
• Intervention / Treatment: Behavioral: CBT in group; Behavioral: individual CBT; Other: Virtual reality exposure

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: El-Hadi ZERDAZI, MD, PhD; Phone Number: +33 + 45 95 83 53; Email: el-hadi.zerdazi@aphp.fr

Study Locations

• France
  • Ile-De-France
    • Créteil, Ile-De-France, France, 94000
      • Recruiting
      • Hôpital Albert Chenevier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 or over, and under 80 on the date of inclusion
• Fulfilling Alcohol use disorder according to the DSM-V criteria (American Psychiatric Association, 2013);
• In alcohol abstinence for at least 15 days;
• Be able to speak, understand and read French;
• Signed an informed consent
• Affiliated to the French health insurance scheme

Exclusion Criteria:

• • Major under legal protection measure, or deprived of liberty by judicial or administrative decision;

  • Pregnant or breastfeeding women;
  • Decompensated psychiatric disoreder (psychotic disorders, mood disorders and anxiety disorders);
  • Alcohol use disorder relapse
  • Severe cognitive impairment as defined by a score of 10 or less at the Montreal Cognitive Assessment (MOCA) (Nasreddine et al., 2005)
  • Visual impairment
  • Contraindications to virtual reality exposure: a history of photosensitive epilepsy, response, balance disorders, recent stroke less than 3 months old, current nausea/vomiting, claustrophobia, and medium or high myopia (beyond -3.5 diopters)
  • Patients wearing one of the following medical devices (due to the risk of interference of the virtual reality headset with them): pacemaker, implanted defibrillator, or implanted hearing aids (non-implanted prostheses are not contraindicated if the patient agrees to remove them during virtual reality exposure)
  • Participation in another trial or being in the exclusion period following previous research involving humans, if applicable
  • Patients not affiliated to the French health insurance scheme and receiving the State Medical Aid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT group	Behavioral: CBT in group; All subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month. VRET consists on 4 weekly sessions (one per week, for 1 month) of 60 to 90 minutes duration. Each session, consists in 20 to 30 minutes exposure with 10 minutes breaks (2 to 3 exposure per session). Four environments will be used: The home environment, the metro advertising environment , the party environment, and the supermarket environment. Each session corresponds to one environment, previously ordered according to their difficulty for the patient.; Behavioral: individual CBT; ll subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month. VRET consists on 4 weekly sessions (one per week, for 1 month) of 60 to 90 minutes duration. Each session, consists in 20 to 30 minutes exposure with 10 minutes breaks (2 to 3 exposure per session). Four environments will be used: The home environment, the metro advertising environment , the party environment, and the supermarket environment. Each session corresponds to one environment, previously ordered according to their difficulty for the patient.
Experimental: VRET group	Behavioral: CBT in group; All subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month. VRET consists on 4 weekly sessions (one per week, for 1 month) of 60 to 90 minutes duration. Each session, consists in 20 to 30 minutes exposure with 10 minutes breaks (2 to 3 exposure per session). Four environments will be used: The home environment, the metro advertising environment , the party environment, and the supermarket environment. Each session corresponds to one environment, previously ordered according to their difficulty for the patient.; Other: Virtual reality exposure; ll subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month. VRET consists on 4 weekly sessions (one per week, for 1 month) of 60 to 90 minutes duration. Each session, consists in 20 to 30 minutes exposure with 10 minutes breaks (2 to 3 exposure per session). Four environments will be used: The home environment, the metro advertising environment , the party environment, and the supermarket environment. Each session corresponds to one environment, previously ordered according to their difficulty for the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative number of alcohol standard drinks	Cumulative number of alcohol standard drinks 8 months after inclusion assessed by the Timeline Follow-Back method (Sobell & Sobell, 1992).	monthly until 8 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving	Level of reported craving assessed by the Transaddiction Craving Triggers Questionnaire (von Hammerstein et al., 2020) and by a Visual Analogue Scale (from 0 to 10) (Drobes & Thomas, 1999).	at inclusion, 2, 5 and 8 months after inclusion
frequency of alcohol hazardous drinks	the frequency is assessed by the Alcohol Use Disorders Identification Test (AUDIT-C) (Bush et al., 1998)	at inclusion, 2, 5 and 8 months after inclusion
Anxiety level	Anxiety level is assessed by the (Generalized Anxiety Disorder-7) (Spitzer et al., 2006)	at inclusion, 2, 5 and 8 months after inclusion
Depression severity	Depression symptoms severity are assessed by the Patient Health Questionnaire 9) (Kroenke et al., 2001).	at inclusion, 2, 5 and 8 months after inclusion
Self-efficacy	Self-efficacy is assessed by Self-efficacy Questionnaire (Jerusalem & Schwarzer, 1992).	at inclusion, 2, 5 and 8 months after inclusion
Repetitive thinking	Repetitive negative thinking is assessed by the The Perseverative Thinking Questionnaire (PTQ) en (Devynck et al, 2017)	at inclusion, 2, 5 and 8 months after inclusion
Virtual environment presence	Virtual environment presence is assessed by the presence questionnaire (Witmer et al.2005)	at inclusion, 2, 5 and 8 months after inclusion
Cybersickness	Cybersickness symptoms are assessed by the Simulator Sickness Questionnaire (Kennedy et al., 1993)	at inclusion, 2, 5 and 8 months after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: APHP221352

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No