Universitat de Barcelona
Barcelona, 08035, Spain
NCT Number: NCT04858061
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08035, Spain
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exposure to alcohol-related cues within virtual environments
Pharmacotherapy and psychotherapy
Time frame: pre-assessment
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
Time frame: at pre-assessment and after 3 weeks
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
Time frame: at pre-assessment and after 3 weeks
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
Time frame: 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
Visual Analogue Scales from 0-100. Higher scores reflect higher levels of craving
Time frame: 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
Visual Analogue Scales from 0-100. Higher scores reflect higher levels of anxiety
University of Barcelona
Other
"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder.
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