Cognitive Rehabilitation Through Personalized Virtual Reality and Paper-and-pencil Interventions in the Alcohol Use Disorder Treatment.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Alcohol Use Disorder (AUD)

Intervention / Treatment
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* Procedure: Virtual Reality
* Procedure: Paper and Pencil
* Procedure: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients of Centro de Alcoologia Ricardo Pampuri (with Alcohol use Disorder diagnosis) Education (able to read and write) Standard neuropharmacological protocol Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City). | Procedure: Virtual Reality<br>* 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).<br>|
| Experimental: Paper and Pencil<br>Standard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool. | Procedure: Paper and Pencil<br>* 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.<br>|
| Active Comparator: Control Group<br>The standard treatment protocol. | Procedure: Control Group<br>* The standard treatment protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (Cognitive Screening). | Change from baseline in the Montreal Cognitive Assessment | 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. | 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 | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toulouse-Pieron (Attention). | Change from baseline in the Toulouse-Pieron Cancellation Test. | 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) | 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. | 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) | 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) | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Use Disorder, Cognitive Rehabilitation, Virtual Reality, Paper-and-Pencil Tasks