Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237796
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2005-10-07
Brief Title:
Functional Rehabilitation of Older Patients With Schizophrenia
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Functional Rehabilitation of Older Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2015-03
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 primary purpose of this project is to evaluate the efficacy of a group therapy intervention cognitive behavioral social skills training CBSST that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia CBSST therefore targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness
Detailed Description:
This is a randomized-controlled clinical trial comparing 2 treatment conditions Goal focused supportive care SC and CBSST Subjects N100 will be recruited treated for 9 months and followed longitudinally for 9 months after treatment A multidimensional evaluation of treatment outcome including social functioning primary outcome neuropsychological functioning cognitive insight psychotic symptoms and health services utilization will be conducted at baseline end of treatment 9-month follow-up and 9 months post-treatment 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid 5000 per assessment visit Subjects will not be paid or given any incentive for treatment The following inclusionexclusion criteria will be used i Voluntary informed consent for participation given by the patient or conservator ii Age 45 or older iii DSM-IV-diagnosis APA 1994 of schizophrenia or schizoaffective disorder at any stage of illness iv No prior exposure to SST or CBT in the past 5 years v Level of care required at baseline does not interfere with outpatient group therapy participation eg partial or inpatient hospitalization for psychiatric or physical illness We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated eg via the internet to relevant clinicians
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