Clinical trial NCT04291586: Comparing the Impact of Virtual Reality and Paper and Pencil on Psychosocial Rehabilitation
Official title: The Impact of Using an Interactive System and a Paper and Pencil Program in Psychosocial Rehabilitation of Psychiatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Disease
Keywords: Virtual Reality
Cognitive Rehabilitation
Psychosocial Rehabilitation
Ecological validity
Personalization
Lead sponsor: Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
Sponsor class: OTHER
Collaborators: name: Universidade da Madeira
First posted: 2020-03-02
Enrollment: 29
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (Cognitive Screening)
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
Secondary outcomes:
measure: Toulouse-Pieron (Attention)
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: Semantic Fluency and Phonemic Fluency Tests
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: Verbal Paired Associates (WMS-III) (Memory)
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: Rey Complex Figure
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: Symbol Search and Coding (WAIS III)
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: Rey 15-Item Memory Test
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
Other outcomes:
measure: Beck Depression Inventory - II
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: Barthel Index
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: Katz Index
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
measure: World Health Organization Quality of Life - Bref (WHOQOL-Bref) - Quality of Life Assessment
timeFrame: Baseline, End (8 weeks) and 8-weeks follow-up
Locations:
city: Funchal
country: Portugal
facility: Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana
state: Funchal-Madeira
Study officials:
affiliation: Madeira Interactive Technologies Institute
name: Sergi Bermudez, Ph,D
role: PRINCIPAL_INVESTIGATOR
References: