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

May 17, 2022 updated by: Sergi Bermúdez i Badia, Universidade da Madeira

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Funchal, Portugal, 9020-126
        • Instituto São João de Deus- CSSJD Funchal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City).
Procedure: Virtual 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).
Experimental: Paper and Pencil
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
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.
Active Comparator: Control Group
The standard treatment protocol.
Procedure: Control Group
The standard treatment protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
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.
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
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
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
Time Frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
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).
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)
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]
Change from baseline in the Letter-number sequencing (WAIS III)
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Madeira

Collaborators

Instituto São João de Deus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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