NCT04505345

Brief Summary

This study aims to test the feasibility of using exercises in virtual reality for cognitive training of patients with alcohol use disorder undergoing residential treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 30, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

August 3, 2020

Last Update Submit

May 9, 2023

Conditions

Cognitive FunctionFeasibility

Outcome Measures

Primary Outcomes (3)

  • Executive functions

    Executive functions are a set of higher order cognitive functions that control goal directed behavior. Executive functions in this study are assessed using the Frontal Assessment Battery that evaluates six constructs: conceptualization, mental flexibility, programming, sensitivity to interference, inhibitory control, and environmental autonomy. This study focuses on the total score that is calculated from sum of scores to each of the six dimensions of the test, in which higher scores describe better test performance.

    5 weeks

  • Cognitive flexibility

    Cognitive flexibility describes the ability to switch between different tasks. Cognitive flexibility in this study is assessed using the Wisconsin Card Sorting Test that evaluates strategic planning, abstract thinking, and capacity for perseveration and the ability to use environmental feedback. This test in this study is scored on six performance parameters: Number of trials administered; number of total errors; number of perseverative errors; number of trials to complete first category; failure to maintain set; and number of conceptual level responses. Higher scores in these dimensions reflect poorer test performance, except for the number of conceptual level responses.

    5 weeks

  • Global cognition

    Global cognition is assessed using the Montreal Cognitive Assessment that is a cognitive screening test that consists of 11 items assessing cognitive domains such as visuospatial orientation, naming, memory, attention, language, abstraction, evocation and orientation. This study focuses on the total score that is calculated from the sum of scores to each dimension of the test, in which higher scores reflect better test performance.

    5 weeks

Study Arms (2)

Virtual reality cognitive training

EXPERIMENTAL

Virtual reality cognitive training consists of a behavioral intervention of 10 sessions of training using virtual reality exercises depicting daily life activities from the Systemic Lisbon Battery aiming cognitive impairments.

Behavioral: Cognitive training using the Systemic Lisbon Battery

Treatment-as-usual

OTHER

Treatment-as-usual for alcohol use disorder (AUD) in our partner institution, a therapeutic community for rehabilitation of AUD, is conducted according to the Minnesota Model requiring alcohol abstinence.

Behavioral: Treatment-as-usual

Interventions

Cognitive training using the Systemic Lisbon BatteryBEHAVIORAL

The Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living.

Virtual reality cognitive training
Treatment-as-usualBEHAVIORAL

Treatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model.

Treatment-as-usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old
  • Without history of psychiatric or neurological disorders
  • Attending the inpatient program for rehabilitation of alcohol use disorder

You may not qualify if:

  • Psychosis episode during the intervention
  • Withdrawal from the inpatient program for rehabilitation of alcohol use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa de Saúde do Telhal

Sintra, 2725-588, Portugal

Location

Related Publications (1)

  • Gamito P, Oliveira J, Matias M, Cunha E, Brito R, Lopes PF, Deus A. Virtual Reality Cognitive Training Among Individuals With Alcohol Use Disorder Undergoing Residential Treatment: Pilot Randomized Controlled Trial. J Med Internet Res. 2021 Jan 29;23(1):e18482. doi: 10.2196/18482.

    PMID: 33512329DERIVED

Study Officials

  • Pedro Gamito, PhD

    University Lusófona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The individuals will be distributed by two groups: experimental and control. The experimental group consists of treatment with virtual reality cognitive training and the control group of treatment-as-usual.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 10, 2020

Study Start

September 30, 2017

Primary Completion

September 30, 2018

Study Completion

July 30, 2024

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)