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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04639895
Enrollment
60
Registered
2020-11-23
Start date
2018-10-22
Completion date
2021-08-30
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorder, Cognitive Rehabilitation, Virtual Reality, Paper-and-Pencil Tasks

Brief 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. 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.

Interventions

PROCEDUREVirtual Reality

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).

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.

PROCEDUREControl Group

The standard treatment protocol.

Sponsors

Instituto São João de Deus
CollaboratorUNKNOWN
Universidade da Madeira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment (Cognitive Screening).Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-upChange from baseline in the Montreal Cognitive Assessment
Frontal Assessment Battery (FAB- Executive functioning).Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-upChange from baseline in the Frontal Assessment Battery.
SF-36 Medical Outcomes Study 36 - Item Short - Form Health SurveyBaseline, Post-intervention (4 weeks), 6-month and 12-month follow-upChange from baseline in the SF-36

Secondary

MeasureTime frameDescription
Symbol Search and Coding (WAIS III).Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]Change from baseline in the Symbol Search and Coding (WAIS III)
Toulouse-Pieron (Attention).Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-upChange from baseline in the Toulouse-Pieron Cancellation Test.
Letter-number sequencing (WAIS-III)- Working MemoryBaseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]Change from baseline in the Letter-number sequencing (WAIS III)
Verbal Paired Associates (WMS-III) (Memory).Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-upChange from baseline in the Verbal Paired Associates (WMS-III)
Rey Complex Figure (Visuospatial skills and visual memory).Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-upChange from baseline in the Rey Complex Figure.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026