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

Primary Purpose

Psychiatric Disease

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Virtual reality
Paper and Pencil
Sponsored by
Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychiatric Disease focused on measuring Virtual Reality, Cognitive Rehabilitation, Psychosocial Rehabilitation, Ecological validity, Personalization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality

Paper and Pencil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment (Cognitive Screening)
Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.

Secondary Outcome Measures

Toulouse-Pieron (Attention)
Change from baseline in the Toulouse-Pieron Cancellation Test.
Semantic Fluency and Phonemic Fluency Tests
Change from baseline in the Semantic Fluency and Phonemic Fluency Tests
Verbal Paired Associates (WMS-III) (Memory)
Change from baseline in the Verbal Paired Associates (WMS-III)
Rey Complex Figure
Change from baseline in the Rey Complex Figure
Symbol Search and Coding (WAIS III)
Change from baseline in the Symbol Search and Coding (WAIS III)
Rey 15-Item Memory Test
Change from baseline in the Rey 15-Item Memory Test

Full Information

First Posted
May 24, 2019
Last Updated
January 5, 2021
Sponsor
Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
Collaborators
Universidade da Madeira
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1. Study Identification

Unique Protocol Identification Number
NCT04291586
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
Collaborators
Universidade da Madeira

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disease
Keywords
Virtual Reality, Cognitive Rehabilitation, Psychosocial Rehabilitation, Ecological validity, Personalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Paper and Pencil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
Intervention Type
Other
Intervention Name(s)
Paper and Pencil
Intervention Description
Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (Cognitive Screening)
Description
Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Secondary Outcome Measure Information:
Title
Toulouse-Pieron (Attention)
Description
Change from baseline in the Toulouse-Pieron Cancellation Test.
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
Semantic Fluency and Phonemic Fluency Tests
Description
Change from baseline in the Semantic Fluency and Phonemic Fluency Tests
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
Verbal Paired Associates (WMS-III) (Memory)
Description
Change from baseline in the Verbal Paired Associates (WMS-III)
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
Rey Complex Figure
Description
Change from baseline in the Rey Complex Figure
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
Symbol Search and Coding (WAIS III)
Description
Change from baseline in the Symbol Search and Coding (WAIS III)
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
Rey 15-Item Memory Test
Description
Change from baseline in the Rey 15-Item Memory Test
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Other Pre-specified Outcome Measures:
Title
Beck Depression Inventory - II
Description
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.
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
Barthel Index
Description
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.
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
Katz Index
Description
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.
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up
Title
World Health Organization Quality of Life - Bref (WHOQOL-Bref) - Quality of Life Assessment
Description
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.
Time Frame
Baseline, End (8 weeks) and 8-weeks follow-up

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergi Bermudez, Ph,D
Organizational Affiliation
Madeira Interactive Technologies Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana
City
Funchal
State/Province
Funchal-Madeira
ZIP/Postal Code
9060-021
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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

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