Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586164
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Enhancing Rehabilitation for Veterans With Serious Mental Illness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Rehabilitation for Veterans With Serious Mental Illness Via Biomarker-Informed Cognitive Training
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses SMI receiving care in VA Psychosocial Rehabilitation and Recovery Centers PRRCs The vast majority of individuals with SMI suffer from cognitive impairments leading to chronic functional disability and impaired outcomes causing a significant strain on support networks and the VA healthcare system This study aims to introduce an innovative mental health therapy Targeted Cognitive Training TCT to Veterans struggling with serious mental illnesses SMI TCT works to improve basic sensory information processing and ultimately clinical cognitive and psychosocial functioning By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment and by understanding how best to implement this therapy the investigators hope to enhance care and improve life quality for Veterans with SMI
Detailed Description:
This application addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses SMI receiving care in VA Psychosocial Rehabilitation and Recovery Centers PRRCs The vast majority of individuals with SMI suffer from cognitive impairments leading to chronic functional disability and impaired outcomes causing a significant strain on support networks and the VA healthcare system This application aims to introduce an innovative mental health therapy Targeted Cognitive Training TCT to Veterans struggling with serious mental illnesses SMI TCT works to improve basic sensory information processing and ultimately clinical cognitive and psychosocial functioning
TCT is a computerized intervention designed to sharpen the acuity and fidelity of sensory information processing through specific exercises that systematically increase demands on early perceptual and attentive processes For many participants TCT leads to bottom-up gains in perceptual functioning that lead to improvements in verbal learning and memory after 20-30h While these benefits of TCT are evident at the group level nearly half of all patients fail to show cognitive gains even after extended 40-100h courses of TCT By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment and by understanding how best to implement this therapy the investigators hope to enhance care and improve life quality for Veterans with SMI
Enrolled patients complete clinical cognitive and functional measures and candidate EEG biomarkers at baseline and then are assigned to Treatment As Usual TAU vs TCTTAU arms n40group using stratified random sampling TAU consists of participation in the standard PRRC programming that includes visits with PRRC clinicians recovery coaching groups and psychotherapy peer services and supported employment Subjects randomized to TCT TAU will also complete 30 hours of TCT consisting of three one-hour training sessions per week Repeat assessment will occur after TCT session 10 20 and 30 or after the equivalent number of weeks have passed for TAU and again 12 weeks after the cessation of TCT to evaluate the durability of observed gains
This project will evaluate whether PRRC outpatients receiving 30 hours of TCT will exhibit significant improvements in clinical symptoms and cognition along with psychosocial functioning and quality of life compared with the TAU group The investigators also hypothesize that favorable responses to 30 hours of TCT will be predicted by behavioral cognitive and EEG-based biomarkers measured at the beginning of the study Finally the investigators will examine the acceptability of TCT and biomarker testing as well as barriers and facilitators to implementation from the perspective of Veterans and PRRC clinicians based on feedback from study participants
TCT is a computerized intervention designed to sharpen the acuity and fidelity of sensory information processing through specific exercises that systematically increase demands on early perceptual and attentive processes For many participants TCT leads to bottom-up gains in perceptual functioning that lead to improvements in verbal learning and memory after 20-30h While these benefits of TCT are evident at the group level nearly half of all patients fail to show cognitive gains even after extended 40-100h courses of TCT By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment and by understanding how best to implement this therapy the investigators hope to enhance care and improve life quality for Veterans with SMI
Enrolled patients complete clinical cognitive and functional measures and candidate EEG biomarkers at baseline and then are assigned to Treatment As Usual TAU vs TCTTAU arms n40group using stratified random sampling TAU consists of participation in the standard PRRC programming that includes visits with PRRC clinicians recovery coaching groups and psychotherapy peer services and supported employment Subjects randomized to TCT TAU will also complete 30 hours of TCT consisting of three one-hour training sessions per week Repeat assessment will occur after TCT session 10 20 and 30 or after the equivalent number of weeks have passed for TAU and again 12 weeks after the cessation of TCT to evaluate the durability of observed gains
This project will evaluate whether PRRC outpatients receiving 30 hours of TCT will exhibit significant improvements in clinical symptoms and cognition along with psychosocial functioning and quality of life compared with the TAU group The investigators also hypothesize that favorable responses to 30 hours of TCT will be predicted by behavioral cognitive and EEG-based biomarkers measured at the beginning of the study Finally the investigators will examine the acceptability of TCT and biomarker testing as well as barriers and facilitators to implementation from the perspective of Veterans and PRRC clinicians based on feedback from study participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None