Psychological Intervention for Persons in the Early Initial Prodromal State

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00204087
• Other study ID #: 01 GI 9935 – P 1.1.2
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 10, 2006
• Start date: January 2001
• Est. completion date: June 2005

Study information

• Verified date: June 1999
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 36 Years

Eligibility

Inclusion Criteria:

1. General criteria

• Age between 17 and 36 years

• male or female, in- or outpatients

• written informed consent, for patients below 18 years also signed by their parents

2. Special criteria (presented within the last three months prior to the study)

1. Self-experienced neuropsychological deficits (basic symptoms)

• Thought interferences

• Compulsory like perseverance of thoughts

• Thought pressure

• Thought blockages

• Disturbances of receptive language, either heard or read

• Decreased ability to discriminate between ideas and perception, fantasy and true memories

• Unstable ideas of reference (subject-centrism)

• Derealisation

• Visual perceptual disturbances (blurred vision, transitory blindness, partial seeing, hypersensitivity of light, etc..)

• Acoustic perceptual disturbances (hypersensitivity to sounds or noise (hypersensitivity to sounds or noise, acoasms, etc.) AND/OR

2. Reduction in the Global Assessment of Functioning Score (DSM IV) of at least 30 points (within the past year) and at least one of the following risk factors:

• First-degree relative with a lifetime-diagnosis of schizophrenia or

• a schizophrenia spectrum disorder

• Pre-or perinatal complications

Exclusion Criteria:

• Attenuated or transient positive symptomes

• Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar according to DSM IV

• Present or past diagnosis a brief psychotic disorder according to DSM IV with a duration of more than one week or within the last 4 weeks regardless of its duration

• Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation psychiatric disorder due to a somatic factor or related to the consumption of psychotropic substances according DSM IV

• Alcohol- or drug abuse within the last three months prior to inclusion according to DSM IV

• Deases of the central nervous system (inflammatory, traumatic, epilepsy etc.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• Cognitive behavioral therapy (CBT)

• Supportive Counselling (SC)

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Cologne	Cologne	North Rhine-Westphalia

Sponsors (6)

Lead Sponsor	Collaborator
University of Cologne	Department of Psychiatry University of Bonn, German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Heinrich-Heine University, Duesseldorf, Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transition to subthreshold psychosis (and psychosis or schizophrenia)
Secondary	improvement of prodromal symptoms (basic symptoms, depression, anxiety)
Secondary	social adjustment

External Links

•   Link
•   Click here for more information about this study: Psychological intervention for persons at risk of psychosis in the early initial prodromal state