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Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis (mCBT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital, Frankfurt
University Hospital Tuebingen
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00465920
First received: April 25, 2007
Last updated: February 19, 2009
Last verified: February 2009
History of Changes
  Purpose

In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which where especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT) for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a realistic estimation of achievable effect size. Patients are randomized to receive either mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20 session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6 months are planned.


Condition Intervention Phase
Psychotic Disorders
Schizophrenia
Schizoaffective Disorder
Delusional Disorder
Schizophreniform Disorder
 Behavioral: modified cognitive behavioural therapy (mCBT)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • PANSS positive syndrome (sum of items P1-P7), assessed during the treatment phase (9 month) monthly and during the follow-up phase (2 years) every 6 months

Secondary Outcome Measures:
  • additional symptom ratings (PSYRATS)
  • social functioning (GAF)
  • illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)
  • quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)

Estimated Enrollment: 42
Study Start Date: May 2007
Estimated Study Completion Date: April 2010
  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia, schizophreniform or schizoaffective disorder (DSM IV 295.1- .9), delusional disorder (DSM IV 297.1)
  • Score of 4 or more on one of the PANSS-items P1, P3, G9
  • Positive psychotic symptoms for 3 months or more
  • Age between 14 and 18
  • Fluently German speaking

Exclusion Criteria:

  • Diagnosis of delirium, dementia, amnestic or other cognitive disorder, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV; diseases of the central nervous system
  • Alcohol- or drug dependence according to DSM IV
  • Verbal IQ < 80
  • Travel time to the study centre of more than 1 hour
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465920

Contacts
Contact: Andreas Bechdolf, PD Dr. +49 221 478 4825 andreas.bechdolf@uk-koeln.de
Contact: Bettina Pohlmann, Dr. + 49 221 478 3870 bettina.pohlmann@uk-koeln.de

Locations
Germany
Department of Psychiatry University Cologne Recruiting
Cologne, North Rhine-Westphalia, Germany, 50937
Contact: Andreas Bechdolf, PD Dr.     +49 221 478 4825     andreas.bechdolf@uk-koeln.de    
Contact: Bettina Pohlmann, Dr.     +49 221 478 3870     bettina.pohlmann@uk-koeln.de    
Principal Investigator: Andreas Bechdolf, PD Dr.            
Sponsors and Collaborators
University of Cologne
University Hospital, Frankfurt
University Hospital Tuebingen
Investigators
Principal Investigator: Andreas Bechdolf, PD Dr. University of Cologne
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00465920     History of Changes
Other Study ID Numbers: 01GV0619
Study First Received: April 25, 2007
Last Updated: February 19, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
schizophrenia
cognitive behavioural therapy
early onset psychosis
Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents

Additional relevant MeSH terms:
Schizophrenia, Paranoid
Delusions
Mental Disorders
Psychotic Disorders
 Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013