Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 6:02 AM
Study NCT ID:
NCT04598906
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2020-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive abilities measured by The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': 'Baseline, 6-12 weeks, 12-24 weeks'}], 'secondaryOutcomes': [{'measure': 'Item performance in Virtual Supermarket Shopping Task', 'timeFrame': 'Baseline, 6-12 weeks', '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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive deficit', 'schizophrenia', 'major depressive disorder', 'virtual environment', 'cognitive rehabilitation'], 'conditions': ['Schizophrenia', 'Depression', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '26229453', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'This study compares effectiveness of the virtual environment cognitive rehabilitation program with standard paper-pencil approach in within-subject design.\n\nParticipants with a diagnosis of schizophrenia, schizoaffective disorder or major depressive disorder will undergo a baseline assessment of cognition.\n\nThe 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.\n\nAll participants will undergo retest assessment of cognition.\n\nAfter 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.\n\nWithin-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia and other primary psychotic disorders or diagnosis of major depressive disorder according to International Classification of Diseases-11\n\nExclusion Criteria:\n\n* Severe visual impairment\n* Age over 60 years\n* Diagnosis of other psychiatric disorder than schizophrenia or major depressive disorder\n* Physical handicap preventing the participant from participating in virtual environment training\n* Refusal to sign an informed consent'}, 'identificationModule': {'nctId': 'NCT04598906', 'briefTitle': 'Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Mental Health, Czech Republic'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'VRremediation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual environment rehabilitation - Paper-pencil rehabilitation', 'description': 'The participants in this arm completes Virtual environment rehabilitation as the first condition and then crossover to Paper-pencil rehabilitation.', 'interventionNames': ['Behavioral: Virtual environment rehabilitation', 'Behavioral: Paper-pencil rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Paper-pencil rehabilitation - Virtual environment rehabilitation', 'description': 'The participants in this arm completes Paper-pencil rehabilitation as the first condition and then crossover to Virtual environment rehabilitation.', 'interventionNames': ['Behavioral: Virtual environment rehabilitation', 'Behavioral: Paper-pencil rehabilitation']}], 'interventions': [{'name': 'Virtual environment rehabilitation', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Paper-pencil rehabilitation - Virtual environment rehabilitation', 'Virtual environment rehabilitation - Paper-pencil rehabilitation']}, {'name': 'Paper-pencil rehabilitation', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Paper-pencil rehabilitation - Virtual environment rehabilitation', 'Virtual environment rehabilitation - Paper-pencil rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '733 01', 'city': 'Fryštát', 'country': 'Czechia', 'facility': 'Mental Health Center', 'geoPoint': {'lat': 49.854, 'lon': 18.54169}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher, PhD student', 'investigatorFullName': 'Adéla Plechatá', 'investigatorAffiliation': 'National Institute of Mental Health, Czech Republic'}}}}