Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression
Primary Purpose
Schizophrenia, Depression, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Virtual environment rehabilitation
Paper-pencil rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring cognitive deficit, schizophrenia, major depressive disorder, virtual environment, cognitive rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizophrenia and other primary psychotic disorders or diagnosis of major depressive disorder according to International Classification of Diseases-11
Exclusion Criteria:
- 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
Sites / Locations
- Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Virtual environment rehabilitation - Paper-pencil rehabilitation
Paper-pencil rehabilitation - Virtual environment rehabilitation
Arm Description
The participants in this arm completes Virtual environment rehabilitation as the first condition and then crossover to Paper-pencil rehabilitation.
The participants in this arm completes Paper-pencil rehabilitation as the first condition and then crossover to Virtual environment rehabilitation.
Outcomes
Primary Outcome Measures
Cognitive abilities measured by The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04598906
First Posted
October 15, 2020
Last Updated
March 1, 2021
Sponsor
National Institute of Mental Health, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04598906
Brief Title
Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Mental Health, Czech Republic
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Depression, Cognitive Impairment
Keywords
cognitive deficit, schizophrenia, major depressive disorder, virtual environment, cognitive rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual environment rehabilitation - Paper-pencil rehabilitation
Arm Type
Experimental
Arm Description
The participants in this arm completes Virtual environment rehabilitation as the first condition and then crossover to Paper-pencil rehabilitation.
Arm Title
Paper-pencil rehabilitation - Virtual environment rehabilitation
Arm Type
Experimental
Arm Description
The participants in this arm completes Paper-pencil rehabilitation as the first condition and then crossover to Virtual environment rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Virtual environment rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Paper-pencil rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive abilities measured by The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame
Baseline, 6-12 weeks, 12-24 weeks
Secondary Outcome Measure Information:
Title
Item performance in Virtual Supermarket Shopping Task
Description
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.
Time Frame
Baseline, 6-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizophrenia and other primary psychotic disorders or diagnosis of major depressive disorder according to International Classification of Diseases-11
Exclusion Criteria:
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
Facility Information:
Facility Name
Mental Health Center
City
Karviná
ZIP/Postal Code
733 01
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26229453
Citation
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.
Results Reference
background
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Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression
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