Comparing the Impact of Virtual Reality and Paper and Pencil on Psychosocial Rehabilitation

NCT ID: NCT04291586

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2020-03-31

Brief Summary

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Virtual Reality allows the integration of cognitive rehabilitation in a more ecologically valid context.

The purpose of this study is to determine whether this methodology has more impact on psychosocial rehabilitation than a paper and pencil personalized program.

Detailed Description

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Cognitive impairments are frequently present on many psychiatric diseases, such as schizophrenia, depression, etc. and are not always given sufficient attention despite its limitations in activities of daily living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday life, and have limited ecological validity.

Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems but, does it have more impact than a paper and pencil personalized intervention?

Through a participatory design approach, with health professionals, the investigators have developed:

a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and; a web tool which generates personalized paper and pencil tasks (Task Generator).

The investigators goal is to have a sample of 30 inpatients from a psychosocial rehabilitation unit, with no age limit, randomly allocated in two groups: 1) the experimental group, where participants will perform 30 minutes of the VR training with Reh@City; and 2) the control group, where participants will perform 30 minutes of the paper and pencil training with the Task Generator.

Conditions

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Psychiatric Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality

The Virtual Reality group will perform personalized activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.

Group Type EXPERIMENTAL

Virtual reality

Intervention Type OTHER

Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Paper and Pencil

The paper and pencil group will perform a set of cognitive paper and pencil tasks personalized to their deficits and generated automatically through a Task Generator.

Group Type ACTIVE_COMPARATOR

Paper and Pencil

Intervention Type OTHER

Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Interventions

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Virtual reality

Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Intervention Type OTHER

Paper and Pencil

Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inpatients of psychosocial rehabilitation unit;
* Cognitive deficit but with enough capacity to understand the task and follow instructions;
* Able to read and write.

Exclusion Criteria

* Patients experiencing an acute psychiatric episode.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade da Madeira

OTHER

Sponsor Role collaborator

Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergi Bermudez, Ph,D

Role: PRINCIPAL_INVESTIGATOR

Madeira Interactive Technologies Institute

Locations

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Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana

Funchal, Funchal-Madeira, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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Casa de Saúde Câmara Pestana

Identifier Type: -

Identifier Source: org_study_id

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