Recruiting

NCT Number: NCT06104176

Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

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.

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Key information

Conditions

Alcool Use Disorder

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Albert Chenevier

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

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT in group

Behavioral

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.

Virtual reality exposure

Other

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.

individual CBT

Behavioral

Primary outcomes

Cumulative number of alcohol standard drinks

Time frame: monthly until 8 months after inclusion

Cumulative number of alcohol standard drinks 8 months after inclusion assessed by the Timeline Follow-Back method (Sobell & Sobell, 1992).

Secondary outcomes

Craving

Time frame: at inclusion, 2, 5 and 8 months after inclusion

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).
frequency of alcohol hazardous drinks

Time frame: at inclusion, 2, 5 and 8 months after inclusion

the frequency is assessed by the Alcohol Use Disorders Identification Test (AUDIT-C) (Bush et al., 1998)
Anxiety level

Time frame: at inclusion, 2, 5 and 8 months after inclusion

Anxiety level is assessed by the (Generalized Anxiety Disorder-7) (Spitzer et al., 2006)
Depression severity

Time frame: at inclusion, 2, 5 and 8 months after inclusion

Depression symptoms severity are assessed by the Patient Health Questionnaire 9) (Kroenke et al., 2001).
Self-efficacy

Time frame: at inclusion, 2, 5 and 8 months after inclusion

Self-efficacy is assessed by Self-efficacy Questionnaire (Jerusalem & Schwarzer, 1992).
Repetitive thinking

Time frame: at inclusion, 2, 5 and 8 months after inclusion

Repetitive negative thinking is assessed by the The Perseverative Thinking Questionnaire (PTQ) en (Devynck et al, 2017)
Virtual environment presence

Time frame: at inclusion, 2, 5 and 8 months after inclusion

Virtual environment presence is assessed by the presence questionnaire (Witmer et al.2005)
Cybersickness

Time frame: at inclusion, 2, 5 and 8 months after inclusion

Cybersickness symptoms are assessed by the Simulator Sickness Questionnaire (Kennedy et al., 1993)

Study contacts

Contact information is provided by the study sponsor or research team.

El-Hadi ZERDAZI, MD, PhD

CONTACT

[email protected]

+ 45 95 83 53 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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)

Acronym: e-ReVA

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Oct 27, 2023
Registry last updated: Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.