Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT02709733
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apathy Evaluation Scale (AES)', 'timeFrame': '9 weeks'}], 'secondaryOutcomes': [{'measure': 'Scale for the Assessment of Negative Symptoms (SANS)', 'timeFrame': '9 weeks'}, {'measure': 'Quality of Life Scale (QLS)', 'timeFrame': '9 weeks'}, {'measure': 'Scale for the Assessment of Positive Symptoms (SAPS)', 'timeFrame': '9 weeks'}, {'measure': 'Brief Assessment of Cognition in Schizophrenia (BACS)', 'timeFrame': '9 weeks'}, {'measure': 'Calgary Depression Scale for Schizophrenia (CDSS)', 'timeFrame': '9 weeks'}, {'measure': 'Simulator Sickness Questionnaire (SSQ)', 'timeFrame': '9 weeks'}, {'measure': 'Functional Brain Imaging', 'timeFrame': '9 weeks', 'description': 'Change in regional brain activity measured with functional MRI'}, {'measure': 'Structural Brain Imaging', 'timeFrame': '9 weeks', 'description': 'Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Negative Symptoms'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.camh.ca/en/research', 'label': 'The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.'}]}, 'descriptionModule': {'briefSummary': 'The loss of motivation has emerged as a critical symptom in schizophrenia that is consistently linked to functional disability for affected individuals. Despite advances in treatment, there have not emerged any effective treatments for this loss of motivation, which ultimately hinders our ability to promote recovery for individuals with schizophrenia. To address this critical unmet therapeutic need, this study aims to investigate a novel computerized motivation rehabilitation program using virtual reality to treat motivation loss in schizophrenia.', 'detailedDescription': 'Motivational deficits have emerged as a critical determinant of functional disability in schizophrenia (SZ). Despite significant advances in our understanding and treatment of the illness, effective therapeutic strategies for motivational deficits have remained elusive. This has ultimately hindered our ability to promote recovery for individuals with SZ so that they can return to their premorbid level of functioning. An emerging therapeutic approach in SZ has utilized computerized remediation strategies, with recent efforts focused on cognitive deficits. To date, however, such a therapeutic strategy has not been developed for the critical motivational deficits in SZ. In light of the detrimental functional consequences of motivational deficits in SZ, there is a clear need for effective therapeutic strategies for the treatment of these motivational deficits experienced by affected individuals. To address this unmet therapeutic need, this pilot therapeutic trial will investigate the efficacy of a novel virtual reality-based motivation rehabilitation program in schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between 18 and 35 years old;\n2. DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;\n3. Outpatients on a stable dose of antipsychotic and other psychotropic medications for the preceding 4 weeks;\n4. Minimum Apathy Evaluation Scale (AES) score of 34.\n\nExclusion Criteria:\n\n1. Diagnosis of other DSM-IV Axis I disorders;\n2. History of active substance abuse or dependence in the past 6 months, with the exception of nicotine;\n3. History of neurological disease;\n4. History of head trauma with loss of consciousness \\>30 minutes\n5. Presence of significant akathisia (a rating of \\>2 on the Barnes Akathisia Rating Scale (BARS) Global item); or\n6. Presence of significant extrapyramidal symptoms (a rating of \\>2 on \\>2 items of the Simpson Angus Rating Scale (SARS))\n7. Any MRI contraindications.'}, 'identificationModule': {'nctId': 'NCT02709733', 'briefTitle': 'Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia', 'orgStudyIdInfo': {'id': '033-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR Motivation Training', 'description': 'Weekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks.', 'interventionNames': ['Behavioral: VR Motivation Training']}], 'interventions': [{'name': 'VR Motivation Training', 'type': 'BEHAVIORAL', 'description': 'Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.', 'armGroupLabels': ['VR Motivation Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 1R8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'George Foussias, MD PhD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician Scientist', 'investigatorFullName': 'George Foussias', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}