A Comparison of Cognitive Training Approaches in Psychotic Disorders
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ClinicalTrials.gov Identifier: NCT03024203 |
Recruitment Status :
Completed
First Posted : January 18, 2017
Last Update Posted : November 14, 2018
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Sponsor:
Queen's University
Information provided by (Responsible Party):
Dr. Christopher Bowie, Queen's University
Tracking Information | |||
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First Submitted Date ICMJE | October 27, 2016 | ||
First Posted Date ICMJE | January 18, 2017 | ||
Last Update Posted Date | November 14, 2018 | ||
Actual Study Start Date ICMJE | August 2016 | ||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ] Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Comparison of Cognitive Training Approaches in Psychotic Disorders | ||
Official Title ICMJE | A Comparison of Cognitive Training Approaches in Psychotic Disorders | ||
Brief Summary | 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Psychotic Disorders | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
70 | ||
Original Estimated Enrollment ICMJE |
60 | ||
Actual Study Completion Date ICMJE | March 2018 | ||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT03024203 | ||
Other Study ID Numbers ICMJE | PSYC-173-16 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Dr. Christopher Bowie, Queen's University | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Queen's University | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Queen's University | ||
Verification Date | November 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |