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

Alcohol Use Disorder (AUD) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639895
• Other study ID #: 1/20
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: May 2022
• Source: Universidade da Madeira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism
• Disease

Intervention

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).
• 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.
• Control Group
The standard treatment protocol.

Locations

Country	Name	City	State
Portugal	Instituto São João de Deus- CSSJD Funchal	Funchal

Sponsors (2)

Lead Sponsor	Collaborator
Universidade da Madeira	Instituto São João de Deus

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Toulouse-Pieron (Attention).	Change from baseline in the Toulouse-Pieron Cancellation Test.	Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Secondary	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
Secondary	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
Secondary	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]
Secondary	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]