Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

Официальное название

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)

Обзор

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.

Вмешательства

• Поведенческое 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).
• Другое 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). F
• Поведенческое 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). F

Первичные конечные точки

• Cumulative number of alcohol standard drinks [Срок оценки: monthly until 8 months after inclusion]

Вторичные конечные точки (8)

• Craving [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]
• frequency of alcohol hazardous drinks [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]
• Anxiety level [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]
• Depression severity [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]
• Self-efficacy [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]
• Repetitive thinking [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]
• Virtual environment presence [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]
• Cybersickness [Срок оценки: at inclusion, 2, 5 and 8 months after inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hôpital Albert Chenevier — Créteil

Публикации

• Negre F, Lemercier-Dugarin M, Gomet R, Pelissolo A, Malbos E, Romo L, Zerdazi EH. Study on the efficiency of virtual reality in the treatment of alcohol use disorder: study protocol for a randomized controlled trial : E-Reva. Trials. 2024 Jun 27;25(1):417. doi: 10.1186/s13063-024-08271-x. PMID 38937776

Идентификаторы

NCT: NCT06104176 · APHP221352

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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