Clinical trial NCT04639895: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Keywords: Alcohol Use Disorder
Cognitive Rehabilitation
Virtual Reality
Paper-and-Pencil Tasks
Lead sponsor: Universidade da Madeira
Sponsor class: OTHER
Collaborators: name: Instituto São João de Deus
First posted: 2020-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Montreal Cognitive Assessment (Cognitive Screening).
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
measure: Frontal Assessment Battery (FAB- Executive functioning).
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
measure: SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Secondary outcomes:
measure: Toulouse-Pieron (Attention).
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
measure: Verbal Paired Associates (WMS-III) (Memory).
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
measure: Rey Complex Figure (Visuospatial skills and visual memory).
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
measure: Symbol Search and Coding (WAIS III).
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]
measure: Letter-number sequencing (WAIS-III)- Working Memory
timeFrame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]
Other outcomes:
Locations:
city: Funchal
country: Portugal
facility: Instituto São João de Deus- CSSJD Funchal
Study officials:
References: