"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder
NCT ID: NCT04858061
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-09-15
2021-06-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment-as-usual supplemented with virtual reality cue-exposure therapy
Treatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET).
Virtual Reality Cue Exposure Therapy
Exposure to alcohol-related cues within virtual environments
Treatment-as-usual
Only treatment-as-usual (TAU)
Treatment-as-usual
Pharmacotherapy and psychotherapy
Interventions
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Virtual Reality Cue Exposure Therapy
Exposure to alcohol-related cues within virtual environments
Treatment-as-usual
Pharmacotherapy and psychotherapy
Eligibility Criteria
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Inclusion Criteria
* Minimum 3 days abstinence before initial evaluation
Exclusion Criteria
* severe psychopathology (e.g. major depression, schizophrenia, dementia)
* opiate addiction
* epilepsy
* severe visual impairments
* pregnancy
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Ministry of Health, Spain
OTHER_GOV
Ministry of Education and Vocational Training, Spain
UNKNOWN
University of Barcelona
OTHER
Responsible Party
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Jose Gutierrez Maldonado
Full Professor
Principal Investigators
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José Gutiérrez Maldonado, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Barcelona
Locations
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Universitat de Barcelona
Barcelona, , Spain
Countries
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Other Identifiers
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2016I078
Identifier Type: -
Identifier Source: org_study_id