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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Schizophreniform Disorder

Intervention / Treatment
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* Behavioral: modified cognitive behavioural therapy (mCBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: modified cognitive behavioural therapy (mCBT)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, cognitive behavioural therapy, early onset psychosis, Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents