DSM-IV 295.30 Schizophrenia, paranoid type DSM-IV 295.10 Schizophrenia disorganized type DSM-IV 295.90 Schizophrenia undifferentiated type DSM-IV 295.60 Schizophrenia residual type DSM-IV 295.40 Schizophreniform disorder DSM-IV 295.70 Schizoaffective disorder DSM-IV 197.1 Delusional disorder F20 F25 F22
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: DSM-IV Schizophrenia diagnosis: 295.30, 295.10, 295.9, 295.60, 295.40, 295.70, 297.1; illness duration > 10 years; MWT-B IQ > 75; physical ability for self-initiated activities; psychic stability for outpatient treatment; fluency of German language; contact person with >/= 10 h contacts / week; travel time to study site < 1 hour
Exclusion criteria
Exclusion criteria: Dementia; unsuccessfully treated diabetes; dependency or substance abuse of psychoactive substances which needs to be treated; Stroke or acute or chronic heart disease within 3 month before inclusion into the study; chronic nervous system related inflammation; malign tumor, major depression (severe)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in one of three: 1. Symptoms: Positive and negative syndrom scale (PANSS) total score: Structured Interview on symptoms in schizophrenia; 2. Depression symptoms: Calgary Depression Rating Scale for Schizophrenia German Version (CDSS-G), Questionaire to be conducted by study participants 3. Functional abilities: UPSA-Brief - University of California, San Diego, Performance-Based Skills Assessment, Rating of study participants behaviour in simple tasks related to standardized situations. Primary endpoints are assessed following randomization (before treatment start), following 4.5 month in the study, following 9 month in the study (treatment end) and following 15 month in the study (6 month follow-up). Outcome no. 3 is not assessed at 4.5 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. STAI trait: State-trait Anxiety Inventory; Fragebogen / Questionaire 2. GAF: global assessement of functioning, Klinische Beurteilung / Rating 3. CERADplus: Consortium to Establish a Registry for Alzheimer’s Disease; neuropsychological assessement 4. ZST: Digit-Symbol-Test, neuropsychological assessment; WHOQOL BREF+OLD: WHO measure of quality of life (german short form and version for elderly subjects) 5. Activities of Dailly Living: Nürnberger Altersinventar, Questionaire 6. SUMD: Scale to assess unawareness of mental disorder; Questionaire 7. Lubben Social Network Scale, Fremd-Rating / structured Interview 8: Documentation of rater blindness to the subjects treatment arm (single blindness protocoll) Only the investigator conducting the psychotherapeutic intervention needs to know the randomization status of the patient. 9: MWT-B: Mehrfachwahl-Wortschatz-Intelligenztest, neuropsychological assessment of premorbid education 10: Blood sample (experimental assessment of probable indicators of neurodegenerative diseases, results not be be communicated to study participants) Outcomes 1-8 are assessed before treatment, at the end of treatment (9 month) and at 6 month follow-up. Outcomes 9 and 10 are assessed before randomisation. Following 4.5 month in the study outcomes 1, 2 and 8 are assessed. | — |
Countries
Germany
Contacts
Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen, Klinik der Universität Duisburg-Essen / Clinic for Psychiatry and Psychotherapy, University of Duisburg-Essen