Cognitive behavioural treatment of negative symptoms in patients with schizophrenic disorders

ISRCTN ISRCTN25455020
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

Department of Psychiatry and Psychotherapy
Osianderstr. 24
Tuebingen
D-72076
Germany

stefan.klingberg@med.uni-tuebingen.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymTONES
Study objectivesCognitive 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) studiedSchizophrenia
InterventionCognitive Behavioural Treatment versus Cognitive Remediation
Intervention typeOther
Primary outcome measurePANSS Modified Negative Factor (N1, N2, N3, N4, N6, G7, G16)
Secondary outcome measures1. 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 date01/01/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants198
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of Psychiatry and Psychotherapy
Tuebingen
D-72076
Germany

Sponsor information

University Hospital Tuebingen (Germany)
University/education

Post Box 2669
Tuebingen
D-72016
Germany

http://www.medizin.uni-tuebingen.de
ROR logo 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2011 Yes No
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