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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidade da Madeira
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Montreal Cognitive Assessment (Cognitive Screening).
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Montreal Cognitive Assessment (Cognitive Screening).
Time Frame: 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).
Time Frame: 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
Time Frame: Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up
Change from baseline in the SF-36
Secondary Outcomes
- Toulouse-Pieron (Attention).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up)
- Verbal Paired Associates (WMS-III) (Memory).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up)
- Letter-number sequencing (WAIS-III)- Working Memory(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up])
- Rey Complex Figure (Visuospatial skills and visual memory).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up)
- Symbol Search and Coding (WAIS III).(Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up])
Investigators
Sergi Bermúdez i Badia
Associate Professor at the University of Madeira and Senior Researcher at NOVA-LINCS
Universidade da Madeira