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Virtual Reality Cognitive Training in Alcohol Use Disorder

Primary Purpose

Cognitive Function, Feasibility

Status
Active
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Cognitive training using the Systemic Lisbon Battery
Treatment-as-usual
Sponsored by
Universidade Lusófona de Humanidades e Tecnologias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Casa de Saúde do Telhal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Virtual reality cognitive training

Treatment-as-usual

Arm Description

Virtual reality cognitive training consists of a behavioral intervention of 10 sessions of training using virtual reality exercises depicting daily life activities from the Systemic Lisbon Battery aiming cognitive impairments.

Treatment-as-usual for alcohol use disorder (AUD) in our partner institution, a therapeutic community for rehabilitation of AUD, is conducted according to the Minnesota Model requiring alcohol abstinence.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2020
Last Updated
May 9, 2023
Sponsor
Universidade Lusófona de Humanidades e Tecnologias
Collaborators
Casa de Saúde do Telhal - Instituto São João de Deus, Portugal.
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1. Study Identification

Unique Protocol Identification Number
NCT04505345
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Lusófona de Humanidades e Tecnologias
Collaborators
Casa de Saúde do Telhal - Instituto São João de Deus, Portugal.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality cognitive training
Arm Type
Experimental
Arm Description
Virtual reality cognitive training consists of a behavioral intervention of 10 sessions of training using virtual reality exercises depicting daily life activities from the Systemic Lisbon Battery aiming cognitive impairments.
Arm Title
Treatment-as-usual
Arm Type
Other
Arm Description
Treatment-as-usual for alcohol use disorder (AUD) in our partner institution, a therapeutic community for rehabilitation of AUD, is conducted according to the Minnesota Model requiring alcohol abstinence.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training using the Systemic Lisbon Battery
Intervention Description
The Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living.
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual
Intervention Description
Treatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model.
Primary Outcome Measure Information:
Title
Executive functions
Description
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.
Time Frame
5 weeks
Title
Cognitive flexibility
Description
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.
Time Frame
5 weeks
Title
Global cognition
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Gamito, PhD
Organizational Affiliation
University Lusófona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casa de Saúde do Telhal
City
Sintra
ZIP/Postal Code
2725-588
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33512329
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.
Results Reference
derived

Learn more about this trial

Virtual Reality Cognitive Training in Alcohol Use Disorder

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