Virtual Reality Cognitive Training in Alcohol Use Disorder

Cognitive Function Clinical Trial

Official title:

Virtual Reality Cognitive Training in Individuals With Alcohol Use Disorder Undergoing Residential Treatment: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04505345
• Other study ID #: SLB_AUD02
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2017
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2023
• Source: Universidade Lusófona de Humanidades e Tecnologias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: July 30, 2024
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Cognitive Function
• Feasibility

Intervention

Behavioral:
• Cognitive training using the Systemic Lisbon Battery
The Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living.
• Treatment-as-usual
Treatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model.

Locations

Country	Name	City	State
Portugal	Casa de Saúde do Telhal	Sintra

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Lusófona de Humanidades e Tecnologias	Casa de Saúde do Telhal - Instituto São João de Deus, Portugal.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive functions	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.	5 weeks
Primary	Cognitive flexibility	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.	5 weeks
Primary	Global cognition	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.	5 weeks