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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN25455020 |
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Date of registration:
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21/11/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cognitive behavioural treatment of negative symptoms in patients with schizophrenic disorders
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Scientific title:
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Date of first enrolment:
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01/01/2006 |
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Target sample size:
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198 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN25455020 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Stefan
Klingberg |
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Address:
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Department of Psychiatry and Psychotherapy
Osianderstr. 24
D-72076
Tuebingen
Germany |
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Telephone:
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Email:
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stefan.klingberg@med.uni-tuebingen.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Schizophrenia (Diagnostic and Statistical Manual of Mental Disorders - fourth edition [DSM-IV] 295.1, 295.2, 295.3, 295.4, 295.6, 295.9)
2. PANSS Modified Negative Syndrome Score =10
3. Fluency of German language
Exclusion criteria: 1. Severe positive symptoms (any item of the standard PANSS positive scale [P1, P2, P3, P4, P5, P6, P7] =6)
2. Severe depression as indicated by PANSS G6 =6
3. Extrapyramidal symptoms
4. Age below 18 or over 55
5. Organic disorder interfering with the central nervous system
6. Verbal IQ <80
7. Diagnosis of substance abuse or substance dependence according to DSM-IV/Structured Clinical Interview for Depression (SCID-I) as primary clinical problem
8. Travel time to the study centre of more than 1 hour
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
Mental and Behavioural Disorders
Schizophrenia
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Intervention(s)
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Cognitive Behavioural Treatment versus Cognitive Remediation
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Primary Outcome(s)
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PANSS Modified Negative Factor (N1, N2, N3, N4, N6, G7, G16)
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Secondary Outcome(s)
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1. Illness related events
2. Scale for the Assessment of Negative Symptoms (SANS)
3. Calgary Depression Scale for Schizophrenia (CDSS)
4. Clinical Global Impression (CGI)
5. Lancashire Quality of Life Profile (LQLP)
6. Social Status
7. Medication Compliance
8. Symptom Checklist 90 Revised (SCL-90-R)
9. Frontal Eye Fields (FEF)
10. Frankfurt Self-concept Scale (FSKN)
11. Neuropsychological assessment
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Secondary ID(s)
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KL1179/3-1
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Source(s) of Monetary Support
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German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany), grant KL1179/3-1
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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