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

U

University of Cologne

Status and phase

Unknown
Phase 2

Conditions

Schizophreniform Disorder
Psychotic Disorders
Schizophrenia
Schizoaffective Disorder
Delusional Disorder

Treatments

Behavioral: modified cognitive behavioural therapy (mCBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT00465920
01GV0619

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Bettina Pohlmann, Dr.; Andreas Bechdolf, PD Dr.

Data sourced from clinicaltrials.gov

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