Psychological Intervention for Persons in the Early Initial Prodromal State - Full Text View

Sponsors and Collaborators:	University of Cologne German Federal Ministry of Education and Research German Research Network On Schizophrenia Department of Psychiatry University of Bonn Heinrich-Heine University, Duesseldorf Ludwig-Maximilians - University of Munich
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00204087

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Psychosis	Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Supportive Counselling (SC)	Phase III

MedlinePlus related topics: Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State

Further study details as provided by University of Cologne:

Primary Outcome Measures:

transition to subthreshold psychosis (and psychosis or schizophrenia)

Secondary Outcome Measures:

improvement of prodromal symptoms (basic symptoms, depression, anxiety)
social adjustment

Estimated Enrollment:	126
Study Start Date:	January 2001
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	17 Years to 36 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)
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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204087

Locations

Germany, North Rhine-Westphalia
Department of Psychiatry and Psychotherapy, University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924

Sponsors and Collaborators

University of Cologne

German Federal Ministry of Education and Research

German Research Network On Schizophrenia

Department of Psychiatry University of Bonn

Heinrich-Heine University, Duesseldorf

Ludwig-Maximilians - University of Munich

Investigators

Study Chair:

Andreas Bechdolf, Dr.

Department of Psychiatry and Psychotherapy, University of Cologne

More Information

Click here for more information about this study: Psychological intervention for persons at risk of psychosis in the early initial prodromal state This link exits the ClinicalTrials.gov site

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	01 GI 9935 – P 1.1.2
Study First Received:	September 12, 2005
Last Updated:	January 10, 2006
ClinicalTrials.gov Identifier:	NCT00204087
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

Schizophrenia
Psychosis
Prodrome

Early Initial Prodromal State
Early Intervention
Cognitive Behavioral Therapy

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009