Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251193
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-01-22
Brief Title:
Optimizing CBSST With Executive Function Training for Schizophrenia
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Optimizing Cognitive Behavioral Social Skills Training With Executive Function Training for Older Adults With Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-08
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-CBSST
Brief Summary:
The purpose of this research study to test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training E-CBSST The aims include determining whether E-CBSST is feasible and increases Cognitive Behavioral Social Skills Training CBSST Skills Learning to a level that will lead to a clinically meaningful improvement in functioning
Detailed Description:
Older adults with schizophrenia are at risk for cognitive and functional decline leading to premature institutionalization A large and increasing number of older people with schizophrenia will need more effective services The investigators previously developed Cognitive Behavioral Social Skills Training CBSST and established its efficacy for preventing functional decline in people with schizophrenia CBSST combines Cognitive Behavioral Therapy CBT Social Skills Training SST and problem-solving intervention modules in an 18-session intervention that is repeated to practice the skills for a total of 36 sessions The findings suggested that CBSST Skills Learning is an important mechanism of change in functioning in CBSST and that boosting executive function could boost CBSST Skills Learning which could improve rather than only stabilize functioning The investigators intend to test a blended intervention that combines CBSST and Executive Functioning Training E-CBSST In this open trial 50 participants with schizophrenia or schizoaffective disorder age 60 or older will be enrolled to receive E-CBSST for 20 weeks E-CBSST will consist first of a 2-week Executive Function Training EFT course that includes 3 sessions per week of computerized exercises and strategy monitoring using a worksheet and assistance from a therapist Participants will then complete 2 cycles of E-CBSST with 18 sessions each cycle delivered twice a week during which participants receive brief EFT at the start of CBSST group sessions Outcome assessments will be administered at baseline end of Executive Function Training course Week 2 after session 18 mid-trial end of first cycle and session 36 end-trial end of second cycle
The aims of the study include determining if E-CBSST is feasible and increases CBSST Skills Learning to a level that will lead to a clinically meaningful improvement in functioning and to identify the minimum number of weeks of the intervention needed to produce this change E-CBSST could become an evidence-based intervention that enhances and not only maintains function and in turn reduces personal and societal burden
The aims of the study include determining if E-CBSST is feasible and increases CBSST Skills Learning to a level that will lead to a clinically meaningful improvement in functioning and to identify the minimum number of weeks of the intervention needed to produce this change E-CBSST could become an evidence-based intervention that enhances and not only maintains function and in turn reduces personal and societal burden
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