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

Not Applicable

Completed

• Conditions: Psychiatric Disease
• Interventions: Other: Paper and Pencil; Other: Virtual reality

• Registration Number: NCT04291586
• Lead Sponsor: Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-24
• Study Start: 2019-06-03
• Primary Completion: 2020-02-07
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Study Completion: 2020-03-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paper and Pencil	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.
Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (Cognitive Screening)	Baseline, End (8 weeks) and 8-weeks follow-up	Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.

Secondary Outcome Measures

Name	Time	Method
Symbol Search and Coding (WAIS III)	Baseline, End (8 weeks) and 8-weeks follow-up	Change from baseline in the Symbol Search and Coding (WAIS III)
Rey 15-Item Memory Test	Baseline, End (8 weeks) and 8-weeks follow-up	Change from baseline in the Rey 15-Item Memory Test
Toulouse-Pieron (Attention)	Baseline, End (8 weeks) and 8-weeks follow-up	Change from baseline in the Toulouse-Pieron Cancellation Test.
Semantic Fluency and Phonemic Fluency Tests	Baseline, End (8 weeks) and 8-weeks follow-up	Change from baseline in the Semantic Fluency and Phonemic Fluency Tests
Rey Complex Figure	Baseline, End (8 weeks) and 8-weeks follow-up	Change from baseline in the Rey Complex Figure
Verbal Paired Associates (WMS-III) (Memory)	Baseline, End (8 weeks) and 8-weeks follow-up	Change from baseline in the Verbal Paired Associates (WMS-III)

Trial Locations

Locations (1)

Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana; 🇵🇹 Funchal, Funchal-Madeira, Portugal