"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder

"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder.

Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Alcohol craving and anxiety are factors contributing to relapse, even after completion of treatment. The current study aims to test the efficacy of a Virtual Reality Cue-Exposure Therapy (VR-CET) patients diagnosed with severe AUD, who made several failed attempts to cease alcohol drinking. It is expected that VR-CET is more efficient in reducing AUD symptomatology and preventing relapses than treatment-as-usual (TAU). 80 participants will be randomly assigned to experimental or control group. The experimental group will receive treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) over the course of five weeks. VR-CET booster sessions consist of exposure to preferred alcoholic beverages and alcohol-related contexts in a VR environment. Throughout the six VR-CET sessions, momentary anxiety and alcohol craving levels will be assessed. The control group will receive only treatment-as-usual (TAU).

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Virtual Reality Cue Exposure Therapy; Behavioral: Treatment-as-usual

Detailed Description

The efficacy of VR Cue Exposure Therapy and Cognitive Behavioral Therapy will be investigated on 80 primarly diagnosed by AUD. Participants will be recruited from Hospital Clínico de Barcelona (Barcelona, Spain). They will be randomly assigned to two booster treatments: treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) versus only treatment as-usual (TAU).

Visuo-tactile and visuo-motor stimulation will be induced to participants to get illusory feelings of ownership over the virtual body. Then patients will be choosing their favorite beverages and favorite places to have drinks. During exposure to a specific beverage in VR, participants' olfactory sense will also be stimulated by pouring the beverage onto a cotton and making the participant smell.

• Virtual Reality-based Cue Exposure Therapy (CET-VR): the intervention will consist of 6 sessions (two per week) lasting approximately 50 minutes. Throughout the sessions, the patient will be exposed to an individualized hierarchy of different VR environments that simulate situations and stimuli related to alcohol consumption. During exposure, the level of craving and anxiety experienced by patients will be assessed using visual analog scales. Once the level of craving has decreased sufficiently (40% of the initial level) in a given situation, it will move to another of greater difficulty to complete the hierarchy. The objective of the intervention is to reduce the craving response of patients in these situations through habituation and extinction processes, so that the generalization of the responses learned during treatment to real situations reduces the risk of relapse.
• Treatment-as-usual (TAU): All participants received therapy on an individual and group basis. The primary therapeutic goal of TAU was to maintain abstinence from alcohol during and after treatment discharge. The treatment consisted of a combination of pharmacotherapy and psychotherapy. Pharmacotherapy generally included medication such as disulfiram, anxiolytics, and/or antidepressants. Individual and group therapy sessions were based on psychotherapeutic approaches like cognitive-behavioral therapy and motivational interviewing. Weekly groups included facilitated recovery-oriented discussions in an open-group format. The TAU groups met once or twice weekly for 1 hour and 30 minutes. Patients assigned to the TAU condition were administered two assessment sessions with a 4-5-week diference in-between.

The initial evaluation session will be approximately one hour. The same evaluation instruments with the same procedure will be implemented in the post-treatment session, once finished either virtual reality or cognitive-behavioral therapy.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Universitat de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with moderate (4-5 diagnostic criteria) or severe (6 or more diagnostic criteria) AUD according to DSM-5
• Minimum 3 days abstinence before initial evaluation

Exclusion Criteria:

• severe cognitive impairment that could interfere with comprehension and completion of the task
• severe psychopathology (e.g. major depression, schizophrenia, dementia)
• opiate addiction
• epilepsy
• severe visual impairments
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment-as-usual supplemented with virtual reality cue-exposure therapy; Treatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET).	Behavioral: Virtual Reality Cue Exposure Therapy; Exposure to alcohol-related cues within virtual environments
Active Comparator: Treatment-as-usual; Only treatment-as-usual (TAU)	Behavioral: Treatment-as-usual; Pharmacotherapy and psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Craving based on AUDIT	Change in Craving levels using the Alcohol Use Disorders Identification Test (AUDIT), with scores ranging from 0 to 40. Higher scores reflect higher levels of craving	pre-assessment
Change in Craving based on MACS	Change in Craving levels using the Multidimensional Alcohol Craving Scale (MACS), with scores ranging from 0 to 60. Higher scores reflect higher levels of craving	at pre-assessment and after 3 weeks
Change in Anxiety	Change in Anxiety levels using the State-Trait Anxiety Inventory (STAI), with scores ranging from 0 to 60. Higher scores reflect higher levels of anxiety	at pre-assessment and after 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Alcohol-related Attentional Bias (Eye-tracking)	Change in Alcohol-related Attentional Bias using an Eye-tracking test	from pre-assessment to post-assessment sessions up to 3 weeks
Change in Alcohol-related Attentional Bias (Stroop)	Change in Alcohol-related Attentional Bias using the Stroop test	from pre-assessment to post-assessment sessions up to 3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving levels during exposure sessions	Visual Analogue Scales from 0-100. Higher scores reflect higher levels of craving	Up to 50 minutes. Baseline (prior to beginning the session), every 20 seconds during the virtual reality session, and at the end of the session
Anxiety levels during exposure sessions	Visual Analogue Scales from 0-100. Higher scores reflect higher levels of anxiety	Up to 50 minutes. Baseline (prior to beginning the session), every 20 seconds during the virtual reality session, and at the end of the session

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Hospital Clinic of Barcelona; Ministry of Health, Spain; Ministry of Education and Vocational Training, Spain
• Investigators: Principal Investigator: José Gutiérrez Maldonado, Prof. Dr., University of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: 2016I078

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No