Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

NCT ID: NCT06104176

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-07-01

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.

Conditions

Alcool Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT group

Group Type: ACTIVE_COMPARATOR

CBT in group

Intervention Type: BEHAVIORAL

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.

individual CBT

Intervention Type: BEHAVIORAL

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.

VRET group

Group Type: EXPERIMENTAL

CBT in group

Intervention Type: BEHAVIORAL

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.

Virtual reality exposure

Intervention Type: 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.

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Albert Chenevier

Créteil, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

El-Hadi ZERDAZI, MD, PhD

Role: CONTACT

el-hadi.zerdazi@aphp.fr

+ 45 95 83 53 ext. +33

References

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.

Reference Type: DERIVED

PMID: 38937776 (View on PubMed)

Other Identifiers

APHP221352

Identifier Type: -

Identifier Source: org_study_id