Psychiatric DiseaseNCT04291586
Comparing the Impact of Virtual Reality and Paper and Pencil on Psychosocial Rehabilitation
A study testing Virtual reality and Paper and Pencil in people with Psychiatric Disease, run by Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Psychiatric Disease
- What is being tested?
- Virtual reality and Paper and Pencil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Jun 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inpatients of psychosocial rehabilitation unit;
- Cognitive deficit but with enough capacity to understand the task and follow instructions;
- Able to read and write.
Who cannot join
- Patients experiencing an acute psychiatric episode.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana
Funchal, Funchal-Madeira, 9060-021
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychiatric Disease
- Being tested
- Virtual reality, Paper and Pencil
- Keywords
- Virtual Reality, Cognitive Rehabilitation, Psychosocial Rehabilitation, Ecological validity, Personalization
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
Paper and PencilOther
Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | 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. Receives: Other: Virtual reality |
| Paper and Pencil | Active comparator | 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. Receives: Other: Paper and Pencil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (Cognitive Screening)
Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.
Measured: Baseline, End (8 weeks) and 8-weeks follow-up
Secondary outcomes (6)
Toulouse-Pieron (Attention)
Change from baseline in the Toulouse-Pieron Cancellation Test.
Measured: 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
Measured: 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)
Measured: Baseline, End (8 weeks) and 8-weeks follow-up
Rey Complex Figure
Change from baseline in the Rey Complex Figure
Measured: 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)
Measured: Baseline, End (8 weeks) and 8-weeks follow-up
Rey 15-Item Memory Test
Change from baseline in the Rey 15-Item Memory Test
Measured: Baseline, End (8 weeks) and 8-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start3 Jun 2019
- Primary completion7 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade da Madeira
- Responsible party
- Sponsor
- Investigators
- Sergi Bermudez, Ph,D, Principal investigator, Madeira Interactive Technologies Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291586
- Sponsor's protocol ID
- Casa de Saúde Câmara Pestana
- Status last verified
- Jan 2021
- First submitted
- 24 May 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using an Interactive System and a Paper and Pencil Program in Psychosocial Rehabilitation of Psychiatric Patients
- ClinicalTrials.gov ID
- NCT04291586
- Acronym / sponsor ID
- Casa de Saúde Câmara Pestana
- Conditions
- Psychiatric Disease
- Keywords
- Virtual Reality, Cognitive Rehabilitation, Psychosocial Rehabilitation, Ecological validity, Personalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto Irmãs Hospitaleiras Sagrado Coração de JesusUniversity, hospital or other
- Collaborators
- Universidade da Madeira
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual realityThe 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. |
| Paper and Pencil | Active comparator | Other: Paper and PencilThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatients of psychosocial rehabilitation unit;
- Cognitive deficit but with enough capacity to understand the task and follow instructions;
- Able to read and write.
Key exclusion criteria (1 listed)
- Patients experiencing an acute psychiatric episode.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityVirtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions. | Other | Virtual Reality |
| Paper and PencilPaper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions. | Other | Paper and Pencil |
Primary outcome
Montreal Cognitive Assessment (Cognitive Screening)
Time frame: Baseline, End (8 weeks) and 8-weeks follow-up
Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.
6 secondary outcomes
Toulouse-Pieron (Attention)
Time frame: Baseline, End (8 weeks) and 8-weeks follow-up
Semantic Fluency and Phonemic Fluency Tests
Time frame: Baseline, End (8 weeks) and 8-weeks follow-up
Verbal Paired Associates (WMS-III) (Memory)
Time frame: Baseline, End (8 weeks) and 8-weeks follow-up
Rey Complex Figure
Time frame: Baseline, End (8 weeks) and 8-weeks follow-up
Symbol Search and Coding (WAIS III)
Time frame: Baseline, End (8 weeks) and 8-weeks follow-up
Rey 15-Item Memory Test
Time frame: Baseline, End (8 weeks) and 8-weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergi Bermudez, Ph,D principal investigator
Madeira Interactive Technologies Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Paper and Pencil in people with Psychiatric Disease, run by Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (Cognitive Screening) (time frame: Baseline, End (8 weeks) and 8-weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.