Clinical trial NCT06104176: Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcool Use Disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative number of alcohol standard drinks
timeFrame: monthly until 8 months after inclusion
Secondary outcomes:
measure: Craving
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
measure: frequency of alcohol hazardous drinks
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
measure: Anxiety level
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
measure: Depression severity
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
measure: Self-efficacy
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
measure: Repetitive thinking
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
measure: Virtual environment presence
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
measure: Cybersickness
timeFrame: at inclusion, 2, 5 and 8 months after inclusion
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Albert Chenevier
state: Ile-De-France
Study officials:
References: