Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756388
Status:
RECRUITING
Last Update Posted:
2022-11-03
First Post:
2021-02-11
Brief Title:
Examining Strategy Monitoring and Remediation Training
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
E-SMART Examining Strategy Monitoring and Remediation Training for Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-SMART
Brief Summary:
Executive Function Training is a cognitive training approach that specifically trains executive functioning for people with schizophrenia-spectrum disorders The current study compares full executive function training to computerized training alone and to strategy monitoring alone
Detailed Description:
All interventions will involve 4 weeks of group treatment consisting of two 1-hour group sessions per week and additional practice at home between sessions The Executive Training condition will consist of 50 of the session practicing computerized cognitive training exercises and 50 of the session developing cognitive strategies to use in the computerized exercises Participants are encouraged to complete 40 minutes of computerized training per day and complete strategy worksheets at home between sessions In Computerized Cognitive Training only participants will spend the entire one-hour session practicing computerized training exercises Between sessions participants will be encouraged to practice the computerized exercises at home for 40 minutes per day There will be no strategy development in this condition In Strategy Development only participants will engage in cognitive strategy discussions to develop new executive function strategies that can be used in daily life Between sessions participants will be encouraged to practice their cognitive strategies in their daily life and track their strategies using the strategy worksheet There will be no computerized cognitive training in this condition All interventions will be delivered virtually in the participants home and group sessions will be conducted using the online platform Zoom
90 participants with schizophrenia-spectrum disorders will be recruited Power analyses conducted with GPower indicate that 90 participants 30 per treatment condition accounting for an upper limit of 25 attrition observed in my previous trials of ET provides 80 power to detect a medium effect size cohens f 02 difference between conditions
Primary and secondary outcomes will be examined using Linear Mixed Models on the Intent-to-Treat sample with missing data interpolated using maximum likelihood estimation The primary endpoint is the 3-month follow-up assessment and secondary endpoint of post-treatment will also be examined
90 participants with schizophrenia-spectrum disorders will be recruited Power analyses conducted with GPower indicate that 90 participants 30 per treatment condition accounting for an upper limit of 25 attrition observed in my previous trials of ET provides 80 power to detect a medium effect size cohens f 02 difference between conditions
Primary and secondary outcomes will be examined using Linear Mixed Models on the Intent-to-Treat sample with missing data interpolated using maximum likelihood estimation The primary endpoint is the 3-month follow-up assessment and secondary endpoint of post-treatment will also be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None