Clinical trial NCT00465920: Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
Official title: Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Goethe University
name: University Hospital Tuebingen
First posted: 2007-04-27
Enrollment: 42
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: additional symptom ratings (PSYRATS)
measure: social functioning (GAF)
measure: illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)
measure: quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Psychiatry University Cologne
state: North Rhine-Westphalia
Study officials:
affiliation: University of Cologne
name: Andreas Bechdolf, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: