NCT00204087

Psychological Intervention for Persons in the Early Initial Prodromal State

Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (planned)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 17 Years – 36 Years
• Healthy volunteers: Not accepted

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 (SC).It 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 decline/stagnation, ? 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.

Conditions

• Schizophrenia
• Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive behavioral therapy (CBT)
BEHAVIORAL	Supportive Counselling (SC)

Timeline

• Start date: 2001-01-01
• Completion: 2005-06-01
• First posted: 2005-09-20
• Last updated: 2006-01-12

Locations

1 site across 1 country: Germany