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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00465920
Acronym
mCBT
Enrollment
42
Registered
2007-04-27
Start date
2007-05-31
Completion date
2010-04-30
Last updated
2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delusional Disorder, Psychotic Disorders, Schizoaffective Disorder, Schizophrenia, 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

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.

Interventions

BEHAVIORALmodified cognitive behavioural therapy (mCBT)

Sponsors

Goethe University
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Germany

Contacts

Primary ContactAndreas Bechdolf, PD Dr.
andreas.bechdolf@uk-koeln.de+49 221 478 4825
Backup ContactBettina Pohlmann, Dr.
bettina.pohlmann@uk-koeln.de+ 49 221 478 3870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026