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

Not Applicable

Completed

• Conditions: Alcohol Use Disorder (AUD)
• Interventions: Procedure: Virtual Reality; Procedure: Paper and Pencil; Procedure: Control Group

• Registration Number: NCT04639895
• Lead Sponsor: Universidade da Madeira

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.

Study Timeline

• Study Start: 2018-10-22
• Primary Completion: 2020-08-30
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-23
• Study Completion: 2021-08-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality	Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City).
Paper and Pencil	Paper and Pencil	Standard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool.
Control Group	Control Group	The standard treatment protocol.

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (Cognitive Screening).	Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up	Change from baseline in the Montreal Cognitive Assessment
Frontal Assessment Battery (FAB- Executive functioning).	Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up	Change from baseline in the Frontal Assessment Battery.
SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey	Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up	Change from baseline in the SF-36

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto São João de Deus- CSSJD Funchal; 🇵🇹 Funchal, Portugal