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

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

Tracking Information

• First Submitted Date: October 23, 2023
• First Posted Date: October 27, 2023
• Last Update Posted Date: November 13, 2023
• Estimated Study Start Date: November 1, 2023
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2023)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 23, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder 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)

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Alcool Use Disorder

Intervention

• 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.

• 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.

Study Arms

• Active Comparator: CBT group
  Interventions:

  • Behavioral: CBT in group
  • Behavioral: individual CBT
• Experimental: VRET group
  Interventions:

  • Behavioral: CBT in group
  • Other: Virtual reality exposure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 23, 2023): 156
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2026
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

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: 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06104176
• Other Study ID Numbers: APHP221352
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: October 2023