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Psychological Intervention for Persons in the Early Initial Prodromal State

Primary Purpose

Schizophrenia, Psychosis

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Supportive Counselling (SC)
Sponsored by
University of Cologne
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Psychosis, Prodrome, Early Initial Prodromal State, Early Intervention, Cognitive Behavioral Therapy

Eligibility Criteria

17 Years - 36 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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) 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 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.)

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of Cologne

Outcomes

Primary Outcome Measures

transition to subthreshold psychosis (and psychosis or schizophrenia)

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
January 10, 2006
Sponsor
University of Cologne
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT00204087
Brief Title
Psychological Intervention for Persons in the Early Initial Prodromal State
Official Title
Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State
Study Type
Interventional

2. Study Status

Record Verification Date
June 1999
Overall Recruitment Status
Unknown status
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cologne
Collaborators
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

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychosis
Keywords
Schizophrenia, Psychosis, Prodrome, Early Initial Prodromal State, Early Intervention, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Type
Behavioral
Intervention Name(s)
Supportive Counselling (SC)
Primary Outcome Measure Information:
Title
transition to subthreshold psychosis (and psychosis or schizophrenia)
Secondary Outcome Measure Information:
Title
improvement of prodromal symptoms (basic symptoms, depression, anxiety)
Title
social adjustment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Bechdolf, Dr.
Organizational Affiliation
Department of Psychiatry and Psychotherapy, University of Cologne
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Cologne
City
Cologne
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28675695
Citation
Wessels H, Wagner M, Kuhr K, Berning J, Putzfeld V, Janssen B, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J, Bechdolf A. Predictors of treatment response to psychological interventions in people at clinical high risk of first-episode psychosis. Early Interv Psychiatry. 2019 Feb;13(1):120-127. doi: 10.1111/eip.12460. Epub 2017 Jul 4.
Results Reference
derived
PubMed Identifier
22075649
Citation
Bechdolf A, Wagner M, Ruhrmann S, Harrigan S, Putzfeld V, Pukrop R, Brockhaus-Dumke A, Berning J, Janssen B, Decker P, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J. Preventing progression to first-episode psychosis in early initial prodromal states. Br J Psychiatry. 2012 Jan;200(1):22-9. doi: 10.1192/bjp.bp.109.066357. Epub 2011 Nov 10.
Results Reference
derived
Links:
URL
http://www.kompetenznetz-schizophrenie.de
Description
Click here for more information about this study: Psychological intervention for persons at risk of psychosis in the early initial prodromal state
URL
http://www.fetz.de
Description
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