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

Study Overview
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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.

Official Title
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The Impact of Using an Interactive System and a Paper and Pencil Program in Psychosocial Rehabilitation of Psychiatric Patients

Conditions
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Psychiatric Disease

Intervention / Treatment
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* Other: Virtual reality
* Other: Paper and Pencil


Participation Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>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. | Other: Virtual reality<br>* Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.<br>|
| Active Comparator: Paper and Pencil<br>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. | Other: Paper and Pencil<br>* Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (Cognitive Screening) | Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes. | Baseline, End (8 weeks) and 8-weeks follow-up | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Cognitive Rehabilitation, Psychosocial Rehabilitation, Ecological validity, Personalization