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

Universidade da Madeira

Status: Completed

Conditions: Alcohol Use Disorder (AUD)

Treatments: Procedure: Control Group; Procedure: Paper and Pencil; Procedure: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04639895

1/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Virtual Reality

Experimental group

Description:

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

Treatment:

Procedure: Virtual Reality

Paper and Pencil

Experimental group

Description:

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

Treatment:

Procedure: Paper and Pencil

Control Group

Active Comparator group

Description:

The standard treatment protocol.

Treatment:

Procedure: Control Group