NCT04639895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

October 27, 2020

Last Update Submit

May 17, 2022

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use DisorderCognitive RehabilitationVirtual RealityPaper-and-Pencil Tasks

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • 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

  • 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]

  • Letter-number sequencing (WAIS-III)- Working Memory

    Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up]

Study Arms (3)

Virtual Reality

EXPERIMENTAL

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

Procedure: Virtual Reality

Paper and Pencil

EXPERIMENTAL

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

Procedure: Paper and Pencil

Control Group

ACTIVE COMPARATOR

The standard treatment protocol.

Procedure: Control Group

Interventions

Virtual RealityPROCEDURE

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).

Virtual Reality
Paper and PencilPROCEDURE

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.

Paper and Pencil
Control GroupPROCEDURE

The standard treatment protocol.

Control Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients of Centro de Alcoologia Ricardo Pampuri (with Alcohol use Disorder diagnosis)
  • Education (able to read and write)
  • Standard neuropharmacological protocol

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto São João de Deus- CSSJD Funchal

Funchal, 9020-126, Portugal

Location

MeSH Terms

Conditions

Alcoholism

Interventions

PaperControl Groups

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and AgricultureEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at the University of Madeira and Senior Researcher at NOVA-LINCS

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 23, 2020

Study Start

October 22, 2018

Primary Completion

August 30, 2020

Study Completion

August 30, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

PT(1)