Virtual Reality Cognitive Training in Alcohol Use Disorder

Not Applicable

Active, not recruiting

• Conditions: Feasibility; Cognitive Function

• Registration Number: NCT04505345
• Lead Sponsor: Universidade Lusófona de Humanidades e Tecnologias

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.

Study Timeline

• Study Start: 2017-09-30
• Primary Completion: 2018-09-30
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global cognition	5 weeks	Global cognition is assessed using the Montreal Cognitive Assessment that is a cognitive screening test that consists of 11 items assessing cognitive domains such as visuospatial orientation, naming, memory, attention, language, abstraction, evocation and orientation. This study focuses on the total score that is calculated from the sum of scores to each dimension of the test, in which higher scores reflect better test performance.
Executive functions	5 weeks	Executive functions are a set of higher order cognitive functions that control goal directed behavior. Executive functions in this study are assessed using the Frontal Assessment Battery that evaluates six constructs: conceptualization, mental flexibility, programming, sensitivity to interference, inhibitory control, and environmental autonomy. This study focuses on the total score that is calculated from sum of scores to each of the six dimensions of the test, in which higher scores describe better test performance.
Cognitive flexibility	5 weeks	Cognitive flexibility describes the ability to switch between different tasks. Cognitive flexibility in this study is assessed using the Wisconsin Card Sorting Test that evaluates strategic planning, abstract thinking, and capacity for perseveration and the ability to use environmental feedback. This test in this study is scored on six performance parameters: Number of trials administered; number of total errors; number of perseverative errors; number of trials to complete first category; failure to maintain set; and number of conceptual level responses. Higher scores in these dimensions reflect poorer test performance, except for the number of conceptual level responses.

Trial Locations

Locations (1)

Casa de Saúde do Telhal; 🇵🇹 Sintra, Portugal