Cognitive behavioural treatment of negative symptoms in patients with schizophrenic disorders
ISRCTN | ISRCTN25455020 |
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DOI | https://doi.org/10.1186/ISRCTN25455020 |
Secondary identifying numbers | KL1179/3-1 |
- Submission date
- 16/09/2005
- Registration date
- 21/11/2005
- Last edited
- 06/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stefan Klingberg
Scientific
Scientific
Department of Psychiatry and Psychotherapy
Osianderstr. 24
Tuebingen
D-72076
Germany
stefan.klingberg@med.uni-tuebingen.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | TONES |
Study objectives | Cognitive Behavioural Treatment (CBT) is more efficacious in reducing negative symptoms (PANSS modified negative symptom factor) in schizophrenic disorders than Cognitive Remediation (CR) |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Schizophrenia |
Intervention | Cognitive Behavioural Treatment versus Cognitive Remediation |
Intervention type | Other |
Primary outcome measure | PANSS Modified Negative Factor (N1, N2, N3, N4, N6, G7, G16) |
Secondary outcome measures | 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 |
Overall study start date | 01/01/2006 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 198 |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2006 |
Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Psychiatry and Psychotherapy
Tuebingen
D-72076
Germany
D-72076
Germany
Sponsor information
University Hospital Tuebingen (Germany)
University/education
University/education
Post Box 2669
Tuebingen
D-72016
Germany
Website | http://www.medizin.uni-tuebingen.de |
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https://ror.org/00pjgxh97 |
Funders
Funder type
Research organisation
German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany), grant KL1179/3-1
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/09/2011 | Yes | No |