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Psychological Intervention for Persons in the Early Initial Prodromal State

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ClinicalTrials.gov Identifier: NCT00204087
Recruitment Status : Unknown
Verified June 1999 by University of Cologne.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : January 12, 2006
Information provided by:

Study Description
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 (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 or disease Intervention/treatment Phase
Schizophrenia Psychosis Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Supportive Counselling (SC) Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State
Study Start Date : January 2001
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. transition to subthreshold psychosis (and psychosis or schizophrenia)

Secondary Outcome Measures :
  1. improvement of prodromal symptoms (basic symptoms, depression, anxiety)
  2. social adjustment

Eligibility Criteria

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Ages Eligible for Study:   17 Years to 36 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204087

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
Study Chair: Andreas Bechdolf, Dr. Department of Psychiatry and Psychotherapy, University of Cologne
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00204087     History of Changes
Other Study ID Numbers: 01 GI 9935 – P 1.1.2
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 12, 2006
Last Verified: June 1999

Keywords provided by University of Cologne:
Early Initial Prodromal State
Early Intervention
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Prodromal Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Signs and Symptoms