Cognitive behavioural treatment of negative symptoms in patients with schizophrenic disorders

ISRCTN	ISRCTN25455020
DOI	https://doi.org/10.1186/ISRCTN25455020
Protocol serial number	KL1179/3-1
Sponsor	University Hospital Tuebingen (Germany)
Funder	German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany), grant KL1179/3-1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Stefan Klingberg
Scientific

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

Email	stefan.klingberg@med.uni-tuebingen.de

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	PANSS Modified Negative Factor (N1, N2, N3, N4, N6, G7, G16)
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Department of Psychiatry and Psychotherapy

Tuebingen
D-72076
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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