Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders) Mental and Behavioural Disorders Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders)
Conditions
Interventions
Cognitive Behavioural Treatment versus Supportive Therapy
Sponsors
University Hospital Tuebingen (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Schizophrenia, schizophreniform, schizoaffective, delusional disorders (according to Diagnostic and Statistical Manual of Mental Disorders - fourth edition [DSM-IV]) 2. Score of four or more on the Positive and Negative Syndrome Scale (PANSS)-items ?delusions? or ?hallucinations? 3. Presence of these symptoms for at least three months
Exclusion criteria
Exclusion criteria: 1. Substance abuse or substance dependence as primary clinical problem 2. Organic brain disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint for efficacy: PANSS positive syndrome (sum of items P1-P7), assessed post treatment (T9). | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: 1. Additional symptom ratings (e.g. PSYRATS) 2. Social functioning 3. Illness related events 4. Quality of life 5. Questionnaires about self schemata and interpersonal schemata 6. Direct and indirect costs Assessment of safety: 1. Death 2. Suicidal behaviour 3. Severe depressive symptom exacerbation | — |
Countries
Germany
Outcome results
None listed