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Clinical Trial Summary

Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Attentional bias (AB) towards alcohol-related stimuli, 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 CBT. 80 participants will be randomly assigned to experimental or control group. Data regarding alcohol craving, anxiety and AB will be assessed prior to, at the end of and 3, 6 and 12 months after completion of the treatment. The experimental group will receive six VR-CET booster sessions 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 CBT.


Clinical Trial 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: 6 sessions of cue exposure therapy (CET-VR) via virtual reality (VR) versus 6 sessions of cognitive behavioral therapy (CBT). Each session will start with filling the questionnaires that will be mentioning below. Secondly, 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. - Cognitive-behavioral therapy (CBT): the intervention will consist of 6 sessions (two per week) of approximately 50 minutes duration. Throughout the six sessions, special work will be done on motivation for change and maintenance of abstinence, as well as relapse prevention (identification of risk situations, coping strategies, assertiveness, drinking rejection skills and problem solving). The experimental evaluation consists of sitting in front of a computer, with an eye-tracking instrument that records the visuo-motor activity. The experiment consists of exploring the attentional bias towards images related to alcohol consumption through different variables that the eye-tracker will provide, such as dwell time, the first fixation towards the images or the total number of fixations towards an area of interest (the areas of interest are either images related to alcohol consumption or neutral images such as office objects). The experiment with eye-tracking technology has a few previous steps to equal in attentional bias and make pairs of images related to alcohol consumption and neutral images. Attentional bias is described in the literature as the physical property of a object to capture attention to the detriment of other objects. The eye-tracking technology is a non-invasive technology, it is a stable device that is placed in front of the computer, and the eye-tracker GazePoint. This device will be used in studies 2 and 4 of this project. The device is placed approximately 60 centimeters distance between the computer and the participant through infrared light, records the visuo-motor activity. The previous steps of the attentional bias evaluation experiment towards images related to alcohol consumption through eye-tracking technology have been developed in approximately 6 months, with collaboration between the Department of Clinical Psychology and Psychobiology and the Department of Psychology of the University of Barcelona. 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. The eye-tracking and psychophysiological recording instruments will NOT be used during the treatment, but only in the pre- and post-treatment evaluation sessions. In order to evaluate the effectiveness of both interventions in the medium and long term, all participants in the study will be examined in follow-up sessions after 3, 6 and 12 months. Follow-up will consist of self-report evaluation of alcohol craving and anxiety, maintenance of abstinence, and alcohol consumption (in case of relapse). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04858061
Study type Interventional
Source University of Barcelona
Contact
Status Active, not recruiting
Phase N/A
Start date September 15, 2018
Completion date June 15, 2021

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