Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

NCT06104176 | Recruiting DMC

• 1 other identifier: APHP221352
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Craving

  at inclusion, 2, 5 and 8 months after inclusion

• frequency of alcohol hazardous drinks

  at inclusion, 2, 5 and 8 months after inclusion

• Anxiety level

  at inclusion, 2, 5 and 8 months after inclusion

• Depression severity

  at inclusion, 2, 5 and 8 months after inclusion

• Self-efficacy

  at inclusion, 2, 5 and 8 months after inclusion

Study Arms (2)

CBT group

ACTIVE COMPARATOR

Behavioral: CBT in group; Behavioral: individual CBT

VRET group

EXPERIMENTAL

Behavioral: CBT in group; Other: Virtual reality exposure

Interventions

CBT in group 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.

CBT group; VRET group

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. 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

individual CBT 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.

CBT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Patients not affiliated to the French health insurance scheme and receiving the State Medical Aid

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Albert Chenevier

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

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Population Groups; Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

El-Hadi ZERDAZI, MD, PhD

CONTACT

+ 45 95 83 53; el-hadi.zerdazi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

FR (1)