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Completed

NCT Number: NCT04639895

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

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.

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto São João de Deus- CSSJD Funchal

Funchal, 9020-126, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual Reality

Procedure

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 Pencil

Procedure

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 Group

Procedure

The standard treatment protocol.

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. Toulouse-Pieron (Attention).

    Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up

    Change from baseline in the Toulouse-Pieron Cancellation Test.

  2. Verbal Paired Associates (WMS-III) (Memory).

    Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up

    Change from baseline in the Verbal Paired Associates (WMS-III)

  3. Rey Complex Figure (Visuospatial skills and visual memory).

    Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up

    Change from baseline in the Rey Complex Figure.

  4. Symbol Search and Coding (WAIS III).

    Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]

    Change from baseline in the Symbol Search and Coding (WAIS III)

  5. Letter-number sequencing (WAIS-III)- Working Memory

    Time frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]

    Change from baseline in the Letter-number sequencing (WAIS III)

Sponsors and collaborators

Lead sponsor

Universidade da Madeira

Other

Collaborators

  • Instituto São João de Deus

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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