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

Primary Purpose

Alcohol Use Disorder (AUD)

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Virtual Reality
Paper and Pencil
Control Group
Sponsored by
Universidade da Madeira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder (AUD) focused on measuring Alcohol Use Disorder, Cognitive Rehabilitation, Virtual Reality, Paper-and-Pencil Tasks

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto São João de Deus- CSSJD Funchal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Virtual Reality

Paper and Pencil

Control Group

Arm Description

Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City).

Standard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool.

The standard treatment protocol.

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment (Cognitive Screening).
Change from baseline in the Montreal Cognitive Assessment
Frontal Assessment Battery (FAB- Executive functioning).
Change from baseline in the Frontal Assessment Battery.
SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey
Change from baseline in the SF-36

Secondary Outcome Measures

Toulouse-Pieron (Attention).
Change from baseline in the Toulouse-Pieron Cancellation Test.
Verbal Paired Associates (WMS-III) (Memory).
Change from baseline in the Verbal Paired Associates (WMS-III)
Rey Complex Figure (Visuospatial skills and visual memory).
Change from baseline in the Rey Complex Figure.
Symbol Search and Coding (WAIS III).
Change from baseline in the Symbol Search and Coding (WAIS III)
Letter-number sequencing (WAIS-III)- Working Memory
Change from baseline in the Letter-number sequencing (WAIS III)

Full Information

First Posted
October 27, 2020
Last Updated
May 17, 2022
Sponsor
Universidade da Madeira
Collaborators
Instituto São João de Deus
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1. Study Identification

Unique Protocol Identification Number
NCT04639895
Brief Title
Cognitive Rehabilitation Through Personalized Virtual Reality and Paper-and-pencil Interventions in the Alcohol Use Disorder Treatment.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira
Collaborators
Instituto São João de Deus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
Alcohol Use Disorder, Cognitive Rehabilitation, Virtual Reality, Paper-and-Pencil Tasks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City).
Arm Title
Paper and Pencil
Arm Type
Experimental
Arm Description
Standard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The standard treatment protocol.
Intervention Type
Procedure
Intervention Name(s)
Virtual Reality
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Paper and Pencil
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control Group
Intervention Description
The standard treatment protocol.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (Cognitive Screening).
Description
Change from baseline in the Montreal Cognitive Assessment
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Title
Frontal Assessment Battery (FAB- Executive functioning).
Description
Change from baseline in the Frontal Assessment Battery.
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Title
SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey
Description
Change from baseline in the SF-36
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Secondary Outcome Measure Information:
Title
Toulouse-Pieron (Attention).
Description
Change from baseline in the Toulouse-Pieron Cancellation Test.
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Title
Verbal Paired Associates (WMS-III) (Memory).
Description
Change from baseline in the Verbal Paired Associates (WMS-III)
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Title
Rey Complex Figure (Visuospatial skills and visual memory).
Description
Change from baseline in the Rey Complex Figure.
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Title
Symbol Search and Coding (WAIS III).
Description
Change from baseline in the Symbol Search and Coding (WAIS III)
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]
Title
Letter-number sequencing (WAIS-III)- Working Memory
Description
Change from baseline in the Letter-number sequencing (WAIS III)
Time Frame
Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Instituto São João de Deus- CSSJD Funchal
City
Funchal
ZIP/Postal Code
9020-126
Country
Portugal

12. IPD Sharing Statement

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

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