Contact information
Type
Scientific
Primary contact
Dr Stefan Klingberg
ORCID ID
Contact details
Department of Psychiatry and Psychotherapy
Osianderstr. 24
Tuebingen
D-72076
Germany
stefan.klingberg@med.uni-tuebingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KL1179/3-1
Study information
Scientific title
Acronym
TONES
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia
Intervention
Cognitive Behavioural Treatment versus Cognitive Remediation
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
198
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Psychiatry and Psychotherapy
Tuebingen
D-72076
Germany
Sponsor information
Organisation
University Hospital Tuebingen (Germany)
Sponsor details
Post Box 2669
Tuebingen
D-72016
Germany
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany), grant KL1179/3-1
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21860053
Publication citations
-
Results
Klingberg S, Wölwer W, Engel C, Wittorf A, Herrlich J, Meisner C, Buchkremer G, Wiedemann G, Negative symptoms of schizophrenia as primary target of cognitive behavioral therapy: results of the randomized clinical TONES study., Schizophr Bull, 2011, 37 Suppl 2, S98-110, doi: 10.1093/schbul/sbr073.