Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248794
Status:
COMPLETED
Last Update Posted:
2016-05-25
First Post:
2005-11-02
Brief Title:
Cognitive Rehabilitation in Schizophrenia
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
The Effects of Cognitive Rehabilitation on Function in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2016-04
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:
None
Brief Summary:
The study will investigate the viability of two cognitive rehabilitation strategies to improve functional outcomes for people with schizophrenia Many people with schizophrenia experience impairments in cognitive function which limit their abilities These impairments have been shown to precede the onset of illness and represent a vulnerability factor which is exacerbated by emerging psychotic symptoms These impairments affect a range of functional domains including symptom severity work function symptom management treatment and overall quality of life Recognizing the link between cognitive impairment and function a few clinicals and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory attention psychomotor speed planning and cognitive flexibility Adaptive skill training involves didactic group exercises in social skills activities of daily living and symptom management Each approach has demonstrated some rehabilitation benefits This study will investigate the effectiveness of a combination of these two approaches on outcomes in schizophrenia
Detailed Description:
Objective Many people with schizophrenia experience impairments in cognitive function which limit their abilities These impairments affect a range of functional domains including symptom severity work function symptom management treatment and overall quality of life Recognizing the link between cognitive impairment and function a few clinicians and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory attention psychomotor speed planning and cognitive flexibility Adaptive skill training involves didactic group exercises in social skills activities of daily living and symptom management This study investigates the effectiveness of a combination of these two approaches on outcomes in schizophrenia This will be a three group randomized clinical trial investigating the effects of cognitive rehabilitation on outcomes ranging from proximal training tasks performance and neuropsychological test performance to more distal outcomes treatment group performance and quality of life ratings We believe that the cognitive augmentation will have significant impact on training task and neuro-psychological test performance and attenuated but significant effect on performance in the treatment groups Finally we hypothesize that the combination of adaptive training and cognitive rehabilitation will have measurable impact on the most distal outcomes such as daily living skills and quality of life Method One hundred 100 individuals will be invited to participate in a 30-week program After informed consent is obtained and diagnosis established participants will receive an extensive assessment of neuropsychological psychological and psychosocial functioning Participants will be randomly assigned to one of three conditions using a stratified procedure based on cognitive test performance this will ensure that there are similar numbers of severely and less severely impaired participants in each condition The three conditions will be 1 a usual care control group which is the Life Skills Development Group LSDG 2 Individualized computer based cognitive rehabilitation ICBCR augmenting the LSDG and 3 Cognitive Remediation Therapy CRT with LSDG Participants will be compared on 1 LSDG performance 2 neuropsychological test performance and 3 psychosocial functioning Attendance in groups and remediation sessions will be compensated at a rate of 5 per session The key questions t be answered are which Cognitive Rehabilitation strategy is more effective at improving cognitive function Does Cognitive Rehabilitation produce better performance in the Life Skills Development Group LSDG Does Life Skills Development Group augmented by Cognitive Rehabilitation produce better psychosocial outcomes than the standard care control group
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00471 | OTHER | VA CT | None |