Status:
UNKNOWN
Psychological Intervention for Persons in the Early Initial Prodromal State
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Conditions:
Schizophrenia
Psychosis
Eligibility:
All Genders
17-36 years
Phase:
PHASE3
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 co...
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 us...
Eligibility Criteria
Inclusion
- 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
- Special criteria (presented within the last three months prior to the study)
- 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
- 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
- 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.)
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00204087
Start Date
January 1 2001
End Date
June 1 2005
Last Update
January 12 2006
Active Locations (1)
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1
Department of Psychiatry and Psychotherapy, University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924