Condition category
Mental and Behavioural Disorders
Date applied
16/09/2005
Date assigned
21/11/2005
Last edited
06/09/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.medizin.uni-tuebingen.de

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

  1. 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.

Additional files

Editorial Notes