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

Schizophrenia Clinical Trial

— mCBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00465920
• Other study ID #: 01GV0619
• Status: Recruiting
• Phase: Phase 2
• First received: April 25, 2007
• Last updated: February 19, 2009
• Start date: May 2007
• Est. completion date: April 2010

Study information

• Verified date: February 2009
• Source: University of Cologne
• Contact: Andreas Bechdolf, PD Dr.
• Phone: +49 221 478 4825
• Email: andreas.bechdolf[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delusional Disorder
• Delusions
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia, Paranoid
• Schizophreniform Disorder

Intervention

Behavioral:
• modified cognitive behavioural therapy (mCBT)

Locations

Country	Name	City	State
Germany	Department of Psychiatry University Cologne	Cologne	North Rhine-Westphalia

Sponsors (3)

Lead Sponsor	Collaborator
University of Cologne	University Hospital Tuebingen, University Hospital, Frankfurt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	additional symptom ratings (PSYRATS)
Secondary	social functioning (GAF)
Secondary	illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)
Secondary	quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)