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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| Ministry of Health, Spain | OTHER_GOV |
| Ministry of Education and Vocational Training, Spain | UNKNOWN |
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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).
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 ClÃnico 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-as-usual supplemented with virtual reality cue-exposure therapy | Experimental | Treatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET). |
|
| Treatment-as-usual | Active Comparator | Only treatment-as-usual (TAU) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Cue Exposure Therapy | Behavioral | Exposure to alcohol-related cues within virtual environments |
|
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Gutiérrez Maldonado, Prof. Dr. | University of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat de Barcelona | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Treatment-as-usual | Behavioral | Pharmacotherapy and psychotherapy |
|
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 |