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

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

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.

Study Overview

• Status: Completed
• Conditions: Psychiatric Disease
• Intervention / Treatment: Other: Virtual reality; Other: Paper and Pencil

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Funchal-Madeira
    • Funchal, Funchal-Madeira, Portugal, 9060-021
      • Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory - II	Change from baseline in the Beck Depression Inventory - II. It is a self-report inventory that aims to measure the severity of depression. Can be scored between 0-63. Minimal depression, 0-11; Mild depression, 12-18; Moderate depression, 19-24; Severe depression, above 25.	Baseline, End (8 weeks) and 8-weeks follow-up
Barthel Index	Change from baseline in the Barthel Index. It's a scale that measures functionality, with features of activities of daily living with the item: bowel control, bladder control, personal hygiene, using the toilet, eating, transferring, walking on a level surface, getting dressed and undressed, going up and down stairs, taking a shower. The maximum score obtainable is 100 points: scores between 91-99, correspond to slight dependence; 61-90, to moderate dependence; 21-60, to serious dependence; and 0-20, to total dependence.	Baseline, End (8 weeks) and 8-weeks follow-up
Katz Index	Change from baseline in the Katz Index. It's a scale that measures functionality, with features of activities of daily living with the item: showering, dressing, using the toilet, sphincter control, mobility and eating. The highest score obtainable is 6, corresponding to independent; scores between 3 and 5, correspond to moderate dependence; and scores below 2, correspond to very dependent.	Baseline, End (8 weeks) and 8-weeks follow-up
World Health Organization Quality of Life - Bref (WHOQOL-Bref) - Quality of Life Assessment	Change from baseline in the WHOQOL-Bref Quality of Life Assessment. This scale is divided in four domains, physical health, social, psychological and environmental. For the physical health we use the questions: 3 (inverse), 4 (inverse),10,15, 16, 17, 18. For the psychological, questions: 5, 6, 7, 11, 19, 26 (inverse). For the social domain, the questions: 20, 21, 22. For the environmental domain, the questions: 8, 9, 12, 13, 14, 23, 24, 25. The main score is obtained through the sum of the four domains and higher scores correspond to higher perceived quality of life.	Baseline, End (8 weeks) and 8-weeks follow-up

Collaborators and Investigators

• Sponsor: Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
• Collaborators: Universidade da Madeira
• Investigators: Principal Investigator: Sergi Bermudez, Ph,D, Madeira Interactive Technologies Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Virtual Reality; Cognitive Rehabilitation; Personalization; Ecological validity; Psychosocial Rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: Casa de Saúde Câmara Pestana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No