Cognitive FunctionNCT04505345
Virtual Reality Cognitive Training in Alcohol Use Disorder
A study testing Cognitive training using the Systemic Lisbon Battery and Treatment-as-usual in people with Cognitive Function and Feasibility, run by Universidade Lusófona de Humanidades e Tecnologias at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Function, Feasibility
- What is being tested?
- Cognitive training using the Systemic Lisbon Battery and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Sep 2017to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Without history of psychiatric or neurological disorders
- Attending the inpatient program for rehabilitation of alcohol use disorder
Who cannot join
- Psychosis episode during the intervention
- Withdrawal from the inpatient program for rehabilitation of alcohol use disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Cognitive Training in Individuals With Alcohol Use Disorder Undergoing Residential Treatment: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cognitive Function, Feasibility
- Being tested
- Cognitive training using the Systemic Lisbon Battery, Treatment-as-usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive training using the Systemic Lisbon BatteryBehavioural
The Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living.
Treatment-as-usualBehavioural
Treatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality cognitive training | Experimental | 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. Receives: Behavioral: Cognitive training using the Systemic Lisbon Battery |
| Treatment-as-usual | Other | 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. Receives: Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Sep 2017
- Primary completion30 Sep 2018
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Lusófona de Humanidades e Tecnologias
- Sponsor type
- University, hospital or other
- Collaborators
- Casa de Saúde do Telhal - Instituto São João de Deus, Portugal.
- Responsible party
- Sponsor
- Investigators
- Pedro Gamito, PhD, Principal investigator, University Lusófona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505345
- Sponsor's protocol ID
- SLB_AUD02
- Status last verified
- May 2023
- First submitted
- 3 Aug 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33512329
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Cognitive Training in Individuals With Alcohol Use Disorder Undergoing Residential Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04505345
- Acronym / sponsor ID
- SLB_AUD02
- Conditions
- Cognitive Function, Feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universidade Lusófona de Humanidades e TecnologiasUniversity, hospital or other
- Collaborators
- Casa de Saúde do Telhal - Instituto São João de Deus, Portugal.
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality cognitive training | Experimental | Behavioral: Cognitive training using the Systemic Lisbon BatteryVirtual 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 | Other | Behavioral: Treatment-as-usualTreatment-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Without history of psychiatric or neurological disorders
- Attending the inpatient program for rehabilitation of alcohol use disorder
Key exclusion criteria (2 listed)
- Psychosis episode during the intervention
- Withdrawal from the inpatient program for rehabilitation of alcohol use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive training using the Systemic Lisbon BatteryThe Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living. | Behavioural | Virtual reality cognitive training |
| Treatment-as-usualTreatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model. | Behavioural | Treatment-as-usual |
Primary outcome
Executive functions
Time frame: 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
Time frame: 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.
Global cognition
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 33512329Gamito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Gamito, PhD principal investigator
University Lusófona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training using the Systemic Lisbon Battery and Treatment-as-usual in people with Cognitive Function and Feasibility, run by Universidade Lusófona de Humanidades e Tecnologias at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive functions (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.