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

NCT00465920 | Unknown Phase 2 DMC

• 1 other identifier: 01GV0619
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Delusional Disorder; Schizophreniform Disorder

Keywords

schizophrenia; cognitive behavioural therapy; early onset psychosis; Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Interventions

modified cognitive behavioural therapy (mCBT) BEHAVIORAL

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• Goethe University: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (1)

Department of Psychiatry University Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Schizophrenia, Paranoid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Andreas Bechdolf, PD Dr.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Bechdolf, PD Dr.

CONTACT

+49 221 478 4825; andreas.bechdolf@uk-koeln.de

Bettina Pohlmann, Dr.

CONTACT

+ 49 221 478 3870; bettina.pohlmann@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: May 1, 2007
• Study Completion: April 1, 2010
• Last Updated: February 20, 2009

Record last verified: 2009-02

Locations

DE (1)