Psychological Intervention for Persons in the Early Initial Prodromal State

NCT ID: NCT00204087

Last Updated: 2006-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2005-06-30

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.

Conditions

Schizophrenia; Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

Supportive Counselling (SC)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.)

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

German Research Network On Schizophrenia

NETWORK

Sponsor Role: collaborator

Department of Psychiatry University of Bonn

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Principal Investigators

Andreas Bechdolf, Dr.

Role: STUDY_CHAIR

Department of Psychiatry and Psychotherapy, University of Cologne

Locations

Department of Psychiatry and Psychotherapy, University of Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 28675695 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22075649 (View on PubMed)

Related Links

http://www.kompetenznetz-schizophrenie.de

Click here for more information about this study: Psychological intervention for persons at risk of psychosis in the early initial prodromal state

http://www.fetz.de

Related Info

Other Identifiers

01 GI 9935 - P 1.1.2

Identifier Type: -

Identifier Source: org_study_id