Clinical trial NCT04505345: Virtual Reality Cognitive Training in Alcohol Use Disorder
Official title: Virtual Reality Cognitive Training in Individuals With Alcohol Use Disorder Undergoing Residential Treatment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Function
Feasibility
Lead sponsor: Universidade Lusófona de Humanidades e Tecnologias
Sponsor class: OTHER
Collaborators: name: Casa de Saúde do Telhal - Instituto São João de Deus, Portugal.
First posted: 2020-08-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The individuals will be distributed by two groups: experimental and control. The experimental group consists of treatment with virtual reality cognitive training and the control group of treatment-as-usual.
Primary purpose: TREATMENT

Brief summary: This study aims to test the feasibility of using exercises in virtual reality for cognitive training of patients with alcohol use disorder undergoing residential treatment.

Detailed description: Alcohol use disorder has been associated with diverse physical and mental morbidities. Among the main consequences of chronic and excessive alcohol use are cognitive and executive deficits. Some of these deficits may be reversed, with improvements in specific cognitive and executive domains, with behavioral approaches consisting in cognitive training. The advent of computer-based interventions may leverage these improvements, but RCTs on the use of digital interactive-based intervention are still scarce.

The aim consists in exploring whether a cognitive training approach using virtual reality exercises based on activities of daily living is feasible for improving cognitive function in patients with alcohol use disorder undergoing residential treatment.

The method consists in a two-arm randomized controlled trial with individuals recovering from alcohol use disorder in a therapeutic community that will be assigned to an experimental and a control group. The experimental group consists of virtual reality-based cognitive training whereas the control group of treatment-as-usual. A comprehensive neuropsychological battery of tests will be used consisting in tests for global cognition, executive functions, and specific tests form memory, attention and cognitive flexibility. The AB design will involve a baseline assessment before intervention and post-intervention assessment.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Without history of psychiatric or neurological disorders
* Attending the inpatient program for rehabilitation of alcohol use disorder

Exclusion Criteria:

* Psychosis episode during the intervention
* Withdrawal from the inpatient program for rehabilitation of alcohol use disorder

Primary outcomes:
measure: Executive functions
timeFrame: 5 weeks
measure: Cognitive flexibility
timeFrame: 5 weeks
measure: Global cognition
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sintra
country: Portugal
facility: Casa de Saúde do Telhal
Study officials:
affiliation: University Lusófona
name: Pedro Gamito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gamito P, Oliveira J, Matias M, Cunha E, Brito R, Lopes PF, Deus A. Virtual Reality Cognitive Training Among Individuals With Alcohol Use Disorder Undergoing Residential Treatment: Pilot Randomized Controlled Trial. J Med Internet Res. 2021 Jan 29;23(1):e18482. doi: 10.2196/18482.