Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204087
Status:
UNKNOWN
Last Update Posted:
2006-01-12
First Post:
2005-09-12
Brief Title:
Psychological Intervention for Persons in the Early Initial Prodromal State
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State
Status:
UNKNOWN
Status Verified Date:
1999-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this randomized controlled trial is to develop a cognitive behavioral therapy CBT for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling SCIt is hypothesized that CBT is more effective than SC on transition to subthreshold psychosis psychosis and schizophrenia as well as on prodromal symptoms and social adjustment
Detailed Description:
Several studies indicated that self-perceived cognitive thought and perception deficits basic symptoms negative symptoms anxiety depressive symptoms and social stagnation or social decline are usually present years before the first episode of schizophrenia appears It is also known that delayed treatment of schizophrenia correlates with a poor prognosis low compliance and high family burden As consequence of these findings for the first time we developed a cognitive behavioral therapy CBT for persons at risk for psychosis in the early initial prodromal state The early initial prodromal state was defined by the presence of self-perseived neuropsychological deficits which were found to be predictive for transition to psychosis and by the presence of clinical relevant decline of functioning in combination with that of clinical management CM Is CBT more effective than CM with regard to the three aims of intervention 1 transition to psychosis 2 improvement of prodromal symptoms 3 prevention of social declinestagnation A randomized controlled trail is used to compare the efficacy of CBT with that of supportive counselling SC Patients are randomized to receive either CBT or SC over a 12 months period CBT comprises of individual and group therapy as well as cognitive remediation and psychoeducation for key persons SC should provide regular supportive contacts for the patient No CBT strategies are allowed to be systematically applied in SC
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