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Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study (e-ReVA)

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ClinicalTrials.gov Identifier: NCT06104176
Recruitment Status : Not yet recruiting
First Posted : October 27, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alcool Use Disorder Behavioral: CBT in group Other: Virtual reality exposure Behavioral: individual CBT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : November 1, 2023
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CBT group Behavioral: 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.


Behavioral: 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.
Experimental: VRET group Behavioral: 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.


Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Craving [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    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).

  2. frequency of alcohol hazardous drinks [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    the frequency is assessed by the Alcohol Use Disorders Identification Test (AUDIT-C) (Bush et al., 1998)

  3. Anxiety level [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    Anxiety level is assessed by the (Generalized Anxiety Disorder-7) (Spitzer et al., 2006)

  4. Depression severity [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    Depression symptoms severity are assessed by the Patient Health Questionnaire 9) (Kroenke et al., 2001).

  5. Self-efficacy [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    Self-efficacy is assessed by Self-efficacy Questionnaire (Jerusalem & Schwarzer, 1992).

  6. Repetitive thinking [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    Repetitive negative thinking is assessed by the The Perseverative Thinking Questionnaire (PTQ) en (Devynck et al, 2017)

  7. Virtual environment presence [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    Virtual environment presence is assessed by the presence questionnaire (Witmer et al.2005)

  8. Cybersickness [ Time Frame: at inclusion, 2, 5 and 8 months after inclusion ]
    Cybersickness symptoms are assessed by the Simulator Sickness Questionnaire (Kennedy et al., 1993)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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: epilepsy or a history of EEG photoparoxysmal 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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT06104176    
Other Study ID Numbers: APHP221352
First Posted: October 27, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders