Alcool Use Disordere-ReVANCT06104176
Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study
A study testing CBT in group, Virtual reality exposure and individual CBT in people with Alcool Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcool Use Disorder
- What is being tested?
- CBT in group, Virtual reality exposure and individual CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Albert Chenevier
Créteil, Île-de-France Region, 94000
About this 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)
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.
Read more
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
- Being tested
- CBT in group, Virtual reality exposure, individual CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT in groupBehavioural
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 exposureOther
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.
individual CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT group | Active comparator | Not described Receives: Behavioral: CBT in group; Behavioral: individual CBT |
| VRET group | Experimental | Not described Receives: Behavioral: CBT in group; Other: Virtual reality exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: monthly until 8 months after inclusion
Secondary outcomes (8)
Craving
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).
Measured: at inclusion, 2, 5 and 8 months after inclusion
frequency of alcohol hazardous drinks
the frequency is assessed by the Alcohol Use Disorders Identification Test (AUDIT-C) (Bush et al., 1998)
Measured: at inclusion, 2, 5 and 8 months after inclusion
Anxiety level
Anxiety level is assessed by the (Generalized Anxiety Disorder-7) (Spitzer et al., 2006)
Measured: at inclusion, 2, 5 and 8 months after inclusion
Depression severity
Depression symptoms severity are assessed by the Patient Health Questionnaire 9) (Kroenke et al., 2001).
Measured: at inclusion, 2, 5 and 8 months after inclusion
Self-efficacy
Self-efficacy is assessed by Self-efficacy Questionnaire (Jerusalem \& Schwarzer, 1992).
Measured: at inclusion, 2, 5 and 8 months after inclusion
Repetitive thinking
Repetitive negative thinking is assessed by the The Perseverative Thinking Questionnaire (PTQ) en (Devynck et al, 2017)
Measured: at inclusion, 2, 5 and 8 months after inclusion
Virtual environment presence
Virtual environment presence is assessed by the presence questionnaire (Witmer et al.2005)
Measured: at inclusion, 2, 5 and 8 months after inclusion
Cybersickness
Cybersickness symptoms are assessed by the Simulator Sickness Questionnaire (Kennedy et al., 1993)
Measured: at inclusion, 2, 5 and 8 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcool Use DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104176
- Sponsor's protocol ID
- APHP221352
- Acronym
- e-ReVA
- Status last verified
- Jan 2025
- First submitted
- 23 Oct 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38937776
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06104176
- Acronym / sponsor ID
- e-ReVA / APHP221352
- Conditions
- Alcool Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT group | Active comparator | Behavioral: CBT in group, Behavioral: individual CBT |
| VRET group | Experimental | Behavioral: CBT in group, Other: Virtual reality exposure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- • Major under legal protection measure, or deprived of liberty by judicial or administrative decision;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT in groupAll 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. | Behavioural | CBT group, VRET group |
| Virtual reality exposurell 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. | Other | VRET group |
| individual CBTll 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. | Behavioural | CBT group |
Primary outcome
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).
8 secondary outcomes
Craving
Time frame: at inclusion, 2, 5 and 8 months after inclusion
frequency of alcohol hazardous drinks
Time frame: at inclusion, 2, 5 and 8 months after inclusion
Anxiety level
Time frame: at inclusion, 2, 5 and 8 months after inclusion
Depression severity
Time frame: at inclusion, 2, 5 and 8 months after inclusion
Self-efficacy
Time frame: at inclusion, 2, 5 and 8 months after inclusion
Repetitive thinking
Time frame: at inclusion, 2, 5 and 8 months after inclusion
Virtual environment presence
Time frame: at inclusion, 2, 5 and 8 months after inclusion
Cybersickness
Time frame: at inclusion, 2, 5 and 8 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 38937776Negre 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.
Related trials for Alcool Use Disorder
Recruiting
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Alcohol Use Disorder, Addiction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in group, Virtual reality exposure and individual CBT in people with Alcool Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact El-Hadi ZERDAZI, MD, PhD (+ 45 95 83 53 ext. +33, el-hadi.zerdazi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of alcohol standard drinks (time frame: monthly until 8 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06104176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.