Psychological Intervention for Persons in the Early Initial Prodromal State

January 10, 2006 updated by: University of Cologne

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 36 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
transition to subthreshold psychosis (and psychosis or schizophrenia)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2006

Last Update Submitted That Met QC Criteria

January 10, 2006

Last Verified

June 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 GI 9935 - P 1.1.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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