Alcohol Use Disorder (AUD)NCT04639895
Cognitive Rehabilitation Through Personalized Virtual Reality and Paper-and-pencil Interventions in the Alcohol Use Disorder Treatment.
A study testing Virtual Reality and Paper and Pencil in people with Alcohol Use Disorder (AUD), run by Universidade da Madeira at 1 site in Portugal.
Trial summary
Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Virtual Reality and Paper and Pencil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Oct 2018to 30 Aug 2021
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients of Centro de Alcoologia Ricardo Pampuri (with Alcohol use Disorder diagnosis)
- Education (able to read and write)
- Standard neuropharmacological protocol
Who cannot join
- Abuse of other substances
- Neurological and psychiatric pathology (present or past)
- Severe depressive symptoms as assessed by the Beck Depression Inventory
- Visual problems that can affect the performance of the tasks (hemianopsy, diplopia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Personalized Virtual Reality and Paper-and-pencil Interventions as Complementary Tools in the Treatment of Alcohol Use Disorder: From Cognitive Rehabilitation to the Prevention of Relapses.
Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory.
This study will explore the clinical impact of two cognitive rehabilitation tools to promote cognitive improvements of AUD individuals.
Read the detailed description
Excessive consumption of alcohol affects many functions associated with the prefrontal and temporal lobes, including different executive functions, memory, and complex motor control. Among several treatments, the Transtheoretical Model, a multidisciplinary approach, is one of the most standardized. However, it lacks effective and innovative cognitive rehabilitation tools. In this study, two cognitive rehabilitation tools, already clinically validated for stroke patients, will be implemented to promote cognitive recovery of Alcohol Use Disorder (AUD) individuals under treatment in the Alcoholic Rehabilitation Center S. Ricardo Pampuri from Casa de Saúde S. João de Deus (Madeira, Portugal). Within a randomized controlled trial with 60 participants, this study intend to assess and compare the clinical effectiveness of both a paper-and-pencil tasks training and content equivalent virtual reality (VR) simulation of activities of daily living with time-matched standard treatment.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Virtual Reality, Paper and Pencil, Control Group
- Keywords
- Alcohol Use Disorder, Cognitive Rehabilitation, Virtual Reality, Paper-and-Pencil Tasks
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityProcedure or surgery
The Virtual Reality group will be involved in the Standard treatment protocol and will perform personalized activities of daily living in a virtual city environment (Reh@City).
Paper and PencilProcedure or surgery
The paper and Pencil group will be involved in the Standard treatment protocol and will perform personalized cognitive paper-and-pencil tasks, using the Task Generator tool.
Control GroupProcedure or surgery
The standard treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City). Receives: Procedure: Virtual Reality |
| Paper and Pencil | Experimental | Standard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool. Receives: Procedure: Paper and Pencil |
| Control Group | Active comparator | The standard treatment protocol. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (Cognitive Screening).
Change from baseline in the Montreal Cognitive Assessment
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Frontal Assessment Battery (FAB- Executive functioning).
Change from baseline in the Frontal Assessment Battery.
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey
Change from baseline in the SF-36
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Secondary outcomes (5)
Toulouse-Pieron (Attention).
Change from baseline in the Toulouse-Pieron Cancellation Test.
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Verbal Paired Associates (WMS-III) (Memory).
Change from baseline in the Verbal Paired Associates (WMS-III)
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Rey Complex Figure (Visuospatial skills and visual memory).
Change from baseline in the Rey Complex Figure.
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Symbol Search and Coding (WAIS III).
Change from baseline in the Symbol Search and Coding (WAIS III)
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]
Letter-number sequencing (WAIS-III)- Working Memory
Change from baseline in the Letter-number sequencing (WAIS III)
Measured: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start22 Oct 2018
- Primary completion30 Aug 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto São João de Deus
- Responsible party
- Principal investigator, Sergi Bermúdez i Badia, Universidade da Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639895
- Sponsor's protocol ID
- 1/20
- Status last verified
- May 2022
- First submitted
- 27 Oct 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Personalized Virtual Reality and Paper-and-pencil Interventions as Complementary Tools in the Treatment of Alcohol Use Disorder: From Cognitive Rehabilitation to the Prevention of Relapses.
- ClinicalTrials.gov ID
- NCT04639895
- Acronym / sponsor ID
- 1/20
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol Use Disorder, Cognitive Rehabilitation, Virtual Reality, Paper-and-Pencil Tasks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Collaborators
- Instituto São João de Deus
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 23 Nov 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.
Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory.
This study will explore the clinical impact of two cognitive rehabilitation tools to promote cognitive improvements of AUD individuals.
Detailed description
Excessive consumption of alcohol affects many functions associated with the prefrontal and temporal lobes, including different executive functions, memory, and complex motor control. Among several treatments, the Transtheoretical Model, a multidisciplinary approach, is one of the most standardized. However, it lacks effective and innovative cognitive rehabilitation tools. In this study, two cognitive rehabilitation tools, already clinically validated for stroke patients, will be implemented to promote cognitive recovery of Alcohol Use Disorder (AUD) individuals under treatment in the Alcoholic Rehabilitation Center S. Ricardo Pampuri from Casa de Saúde S. João de Deus (Madeira, Portugal). Within a randomized controlled trial with 60 participants, this study intend to assess and compare the clinical effectiveness of both a paper-and-pencil tasks training and content equivalent virtual reality (VR) simulation of activities of daily living with time-matched standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Procedure: Virtual RealityStandard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City). |
| Paper and Pencil | Experimental | Procedure: Paper and PencilStandard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool. |
| Control Group | Active comparator | Procedure: Control GroupThe standard treatment protocol. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatients of Centro de Alcoologia Ricardo Pampuri (with Alcohol use Disorder diagnosis)
- Education (able to read and write)
- Standard neuropharmacological protocol
Key exclusion criteria (4 listed)
- Abuse of other substances
- Neurological and psychiatric pathology (present or past)
- Severe depressive symptoms as assessed by the Beck Depression Inventory
- Visual problems that can affect the performance of the tasks (hemianopsy, diplopia)
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 |
|---|---|---|
| Virtual RealityThe Virtual Reality group will be involved in the Standard treatment protocol and will perform personalized activities of daily living in a virtual city environment (Reh@City). | Procedure or surgery | Virtual Reality |
| Paper and PencilThe paper and Pencil group will be involved in the Standard treatment protocol and will perform personalized cognitive paper-and-pencil tasks, using the Task Generator tool. | Procedure or surgery | Paper and Pencil |
| Control GroupThe standard treatment protocol. | Procedure or surgery | Control Group |
Primary outcome
Montreal Cognitive Assessment (Cognitive Screening).
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Change from baseline in the Montreal Cognitive Assessment
Frontal Assessment Battery (FAB- Executive functioning).
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Change from baseline in the Frontal Assessment Battery.
SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Change from baseline in the SF-36
5 secondary outcomes
Toulouse-Pieron (Attention).
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Verbal Paired Associates (WMS-III) (Memory).
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Rey Complex Figure (Visuospatial skills and visual memory).
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Symbol Search and Coding (WAIS III).
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]
Letter-number sequencing (WAIS-III)- Working Memory
Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Related trials for Alcohol Use Disorder (AUD)
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
eTSF for Latinx Young Adults With Alcohol Use Disorder
Alcohol Use Disorder (AUD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Paper and Pencil in people with Alcohol Use Disorder (AUD), run by Universidade da Madeira 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 4 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: finished, as of the sponsor's last update on 18 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Montreal Cognitive Assessment (Cognitive Screening). (time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up). 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?
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 18 May 2022.