Psychotic Disorders Clinical Trial
Official title:
A Comparison of Cognitive Training Approaches in Psychotic Disorders
NCT number | NCT03024203 |
Other study ID # | PSYC-173-16 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | March 2018 |
Verified date | November 2018 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. Cognitive training refers to the training component of CR in which people practice computerized exercises that train specific cognitive abilities. There is no agreed upon approach within the field as to the type of training that is most effective with some studies, training higher level cognitive abilities, some training perceptual abilities, and others training general cognitive skills. This study will directly compare two competing methods of cognitive training on measures of neurophysiology, neurocognition, functional competence, and real-world functional performance.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - psychotic disorder - No previous cognitive remediation in past 6 months Exclusion Criteria: - Brain injury - Substance abuse - Neurocognitive disorder - Developmental Disability |
Country | Name | City | State |
---|---|---|---|
Canada | Queen's University | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline | Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks | Post-treatment (within 2 weeks following the end of treatment) | |
Secondary | Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline | The MCCB is the gold standard cognitive assessment for schizophrenia research | Post-treatment (within 2 weeks following the end of treatment) | |
Secondary | Change in Neurophysiology - EEG from Baseline | Alpha and Theta band synchronization, p300, mismatch negativity | Post-treatment (within 2 weeks following the end of treatment) | |
Secondary | Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline | Performance based measure of real life functional skills using role-play | Post-treatment (within 2 weeks following the end of treatment) | |
Secondary | Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline | Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks | Follow-Up (3 months after the end of treatment) | |
Secondary | Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline | The MCCB is the gold standard cognitive assessment for schizophrenia research | Follow-Up (3 months after the end of treatment) | |
Secondary | Change in Neurophysiology - EEG from Baseline | Alpha and Theta band synchronization, p300, mismatch negativity | Follow-Up (3 months after the end of treatment) | |
Secondary | Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline | Performance based measure of real life functional skills using role-play | Follow-Up (3 months after the end of treatment) |
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