SchizophreniaNCT04598906
Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression
A study testing Virtual environment rehabilitation and Paper-pencil rehabilitation in people with Schizophrenia and Depression, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
Trial summary
Schizophrenia is heterogeneous and often disabling a disease that affects 1% of the population. Current psychopharmacological treatment significantly eliminates the presence of positive symptoms (especially delusions and hallucinations) and partly also negative symptoms (social withdrawal or abulia). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Depression, Cognitive Impairment
- What is being tested?
- Virtual environment rehabilitation and Paper-pencil rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2019to 1 Jan 2021
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia and other primary psychotic disorders or diagnosis of major depressive disorder according to International Classification of Diseases-11
Who cannot join
- Severe visual impairment
- Age over 60 years
- Diagnosis of other psychiatric disorder than schizophrenia or major depressive disorder
- Physical handicap preventing the participant from participating in virtual environment training
- Refusal to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of the Virtual Environment in Cognitive Rehabilitation With Standard Rehabilitation Methods in Patients With Schizophrenia and in Patients With Major Depressive Disorder
Schizophrenia is heterogeneous and often disabling a disease that affects 1% of the population. Current psychopharmacological treatment significantly eliminates the presence of positive symptoms (especially delusions and hallucinations) and partly also negative symptoms (social withdrawal or abulia). In contrast, the cognitive deficits associated both with schizophrenia and depression are only limitedly influenced by pharmacological treatment.The cognitive impairment represents an important part of schizophrenia symptomatology and it has a severe negative impact on patients' quality of life. In depression is the impairment milder but still significantly contributes to patients' daily functioning. The profound deficit was repeatedly documented in the area of declarative and working memory. In this study, we study the effectiveness of virtual environment rehabilitation program focused on declarative memory, working memory and attention in comparison to standard paper-pencil rehabilitation led by an occupational therapist.
Read the detailed description
This study compares effectiveness of the virtual environment cognitive rehabilitation program with standard paper-pencil approach in within-subject design.
Participants with a diagnosis of schizophrenia, schizoaffective disorder or major depressive disorder will undergo a baseline assessment of cognition.
The participants will be at the baseline randomly assigned to each condition: virtual environment rehabilitation or paper-pencil rehabilitation. Then they will participate in 10-15 sessions (30-45 minutes) once or twice a week.
All participants will undergo retest assessment of cognition.
After completion of the first program the participants will be assigned to the different condition: to paper-pencil or virtual environment rehabilitation. After 10-15 sessions in the second condition the participants will once more undergo retest assessment of cognition.
Within-subject design is an effective tool in the development of scientifically proven treatment tools. This approach allows to obtain reliable information about the effectiveness of the method and to examine the influences of other variables (Steingrimsdottir and Arntzen 2015). This study will allow to get credible information on the importance of using the virtual environment in the context of cognitive rehabilitation in patients with schizophrenia and depression.
- Conditions
- Schizophrenia, Depression, Cognitive Impairment
- Being tested
- Virtual environment rehabilitation, Paper-pencil rehabilitation
- Keywords
- cognitive deficit, schizophrenia, major depressive disorder, virtual environment, cognitive rehabilitation
- Medical subject headings
- Schizophrenia, Depression, Cognitive Dysfunction, Cognition Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual environment rehabilitationBehavioural
The participants attended 10-15 computer sessions during 6-12 weeks. Each session lasted 30 minutes and consisted of the set of virtual environment tasks (Shooting Range,Virtual Supermarket Shopping Task and Objects). Shooting range demands differentiation of targets from non-targets and focuses on training of selective attention, psychomotor speed and inhibition control. Virtual Supermarket Shopping requires memorizing the shopping list and searching for products in the supermarket area. Objects requires memorizing of the spatial and temporal context while searching for objects.
Paper-pencil rehabilitationBehavioural
The participants in the paper-pencil rehabilitation attended 10-15 paper pencil sessions for 6-12 weeks. Each session lasted 45 minutes. Each paper-pencil session starts with a warm-up game. The session continues with a set of paper-pencil tasks focused on attention, fine motor skills, recall, short-term and long-term memory, verbal fluency, visual search, cognitive flexibility, abstraction and executive functions, numerical abilities. The tasks are adapted according to the participant´s abilities.
| Study group | Role | What they receive |
|---|---|---|
| Virtual environment rehabilitation - Paper-pencil rehabilitation | Experimental | The participants in this arm completes Virtual environment rehabilitation as the first condition and then crossover to Paper-pencil rehabilitation. Receives: Behavioral: Virtual environment rehabilitation; Behavioral: Paper-pencil rehabilitation |
| Paper-pencil rehabilitation - Virtual environment rehabilitation | Experimental | The participants in this arm completes Paper-pencil rehabilitation as the first condition and then crossover to Virtual environment rehabilitation. Receives: Behavioral: Virtual environment rehabilitation; Behavioral: Paper-pencil rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive abilities measured by The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Baseline, 6-12 weeks, 12-24 weeks
Secondary outcomes (1)
Item performance in Virtual Supermarket Shopping Task
The data from individual sessions with Virtual Supermarket Shopping Task will be analyzed to see participants' progress. The variable item performance will be used = number of items to remember/ correctly collected items.
Measured: Baseline, 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Sep 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adéla Plechatá, National Institute of Mental Health, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598906
- Sponsor's protocol ID
- VRremediation
- Status last verified
- Mar 2021
- First submitted
- 15 Oct 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steingrimsdottir HS, Arntzen E. On the utility of within-participant research design when working with patients with neurocognitive disorders. Clin Interv Aging. 2015 Jul 23;10:1189-99. doi: 10.2147/CIA.S81868. eCollection 2015.
PubMed 26229453
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of the Virtual Environment in Cognitive Rehabilitation With Standard Rehabilitation Methods in Patients With Schizophrenia and in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04598906
- Acronym / sponsor ID
- VRremediation
- Conditions
- Schizophrenia, Depression, Cognitive Impairment
- Keywords
- cognitive deficit, schizophrenia, major depressive disorder, virtual environment, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 22 Oct 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.
Schizophrenia is heterogeneous and often disabling a disease that affects 1% of the population. Current psychopharmacological treatment significantly eliminates the presence of positive symptoms (especially delusions and hallucinations) and partly also negative symptoms (social withdrawal or abulia). In contrast, the cognitive deficits associated both with schizophrenia and depression are only limitedly influenced by pharmacological treatment.The cognitive impairment represents an important part of schizophrenia symptomatology and it has a severe negative impact on patients' quality of life. In depression is the impairment milder but still significantly contributes to patients' daily functioning. The profound deficit was repeatedly documented in the area of declarative and working memory. In this study, we study the effectiveness of virtual environment rehabilitation program focused on declarative memory, working memory and attention in comparison to standard paper-pencil rehabilitation led by an occupational therapist.
Detailed description
This study compares effectiveness of the virtual environment cognitive rehabilitation program with standard paper-pencil approach in within-subject design.
Participants with a diagnosis of schizophrenia, schizoaffective disorder or major depressive disorder will undergo a baseline assessment of cognition.
The participants will be at the baseline randomly assigned to each condition: virtual environment rehabilitation or paper-pencil rehabilitation. Then they will participate in 10-15 sessions (30-45 minutes) once or twice a week.
All participants will undergo retest assessment of cognition.
After completion of the first program the participants will be assigned to the different condition: to paper-pencil or virtual environment rehabilitation. After 10-15 sessions in the second condition the participants will once more undergo retest assessment of cognition.
Within-subject design is an effective tool in the development of scientifically proven treatment tools. This approach allows to obtain reliable information about the effectiveness of the method and to examine the influences of other variables (Steingrimsdottir and Arntzen 2015). This study will allow to get credible information on the importance of using the virtual environment in the context of cognitive rehabilitation in patients with schizophrenia and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual environment rehabilitation - Paper-pencil rehabilitation | Experimental | Behavioral: Virtual environment rehabilitation, Behavioral: Paper-pencil rehabilitationThe participants in this arm completes Virtual environment rehabilitation as the first condition and then crossover to Paper-pencil rehabilitation. |
| Paper-pencil rehabilitation - Virtual environment rehabilitation | Experimental | Behavioral: Virtual environment rehabilitation, Behavioral: Paper-pencil rehabilitationThe participants in this arm completes Paper-pencil rehabilitation as the first condition and then crossover to Virtual environment rehabilitation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of schizophrenia and other primary psychotic disorders or diagnosis of major depressive disorder according to International Classification of Diseases-11
Key exclusion criteria (5 listed)
- Severe visual impairment
- Age over 60 years
- Diagnosis of other psychiatric disorder than schizophrenia or major depressive disorder
- Physical handicap preventing the participant from participating in virtual environment training
- Refusal to sign an informed consent
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 environment rehabilitationThe participants attended 10-15 computer sessions during 6-12 weeks. Each session lasted 30 minutes and consisted of the set of virtual environment tasks (Shooting Range,Virtual Supermarket Shopping Task and Objects). Shooting range demands differentiation of targets from non-targets and focuses on training of selective attention, psychomotor speed and inhibition control. Virtual Supermarket Shopping requires memorizing the shopping list and searching for products in the supermarket area. Objects requires memorizing of the spatial and temporal context while searching for objects. | Behavioural | Paper-pencil rehabilitation - Virtual environment rehabilitation, Virtual environment rehabilitation - Paper-pencil rehabilitation |
| Paper-pencil rehabilitationThe participants in the paper-pencil rehabilitation attended 10-15 paper pencil sessions for 6-12 weeks. Each session lasted 45 minutes. Each paper-pencil session starts with a warm-up game. The session continues with a set of paper-pencil tasks focused on attention, fine motor skills, recall, short-term and long-term memory, verbal fluency, visual search, cognitive flexibility, abstraction and executive functions, numerical abilities. The tasks are adapted according to the participant´s abilities. | Behavioural | Paper-pencil rehabilitation - Virtual environment rehabilitation, Virtual environment rehabilitation - Paper-pencil rehabilitation |
Primary outcome
Cognitive abilities measured by The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: Baseline, 6-12 weeks, 12-24 weeks
1 secondary outcome
Item performance in Virtual Supermarket Shopping Task
Time frame: Baseline, 6-12 weeks
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 2 Mar 2021.
- Background: PubMed 26229453Steingrimsdottir HS, Arntzen E. On the utility of within-participant research design when working with patients with neurocognitive disorders. Clin Interv Aging. 2015 Jul 23;10:1189-99. doi: 10.2147/CIA.S81868. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 environment rehabilitation and Paper-pencil rehabilitation in people with Schizophrenia and Depression, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
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 1 inclusion and 5 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 2 Mar 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 Czechia. 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?
Cognitive abilities measured by The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (time frame: Baseline, 6-12 weeks, 12-24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598906, which also lists 1 linked publication.
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 2 Mar 2021.