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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	14 November 2022
Main ID:	ISRCTN29242879
Date of registration:	26/01/2007
Prospective Registration:	No
Primary sponsor:	University Hospital Tuebingen (Germany)
Public title:	Cognitive behavioural treatment for persistent positive symptoms in psychotic disorders
Scientific title:	-
Date of first enrolment:	01/01/2007
Target sample size:	260
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN29242879
Study type:	Interventional
Study design:	Randomised, single blind, parallel group, prospective, controlled study comparing a specific treatment with an unspecific, ?placebo?-attention control group (Treatment)
Phase:	Not Specified

Countries of recruitment
Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Stefan Klingberg
Address:	Osianderstr. 24 72076 Tuebingen Germany
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Schizophrenia, schizophreniform, schizoaffective, delusional disorders (according to Diagnostic and Statistical Manual of Mental Disorders - fourth edition [DSM-IV])
2. Score of four or more on the Positive and Negative Syndrome Scale (PANSS)-items ?delusions? or ?hallucinations?
3. Presence of these symptoms for at least three months

Exclusion criteria:
1. Substance abuse or substance dependence as primary clinical problem
2. Organic brain disease

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders)
Mental and Behavioural Disorders
Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders)

Intervention(s)

Cognitive Behavioural Treatment versus Supportive Therapy

Primary Outcome(s)

Primary endpoint for efficacy: PANSS positive syndrome (sum of items P1-P7), assessed post treatment (T9).

Secondary Outcome(s)

Key secondary endpoints:
1. Additional symptom ratings (e.g. PSYRATS)
2. Social functioning
3. Illness related events
4. Quality of life
5. Questionnaires about self schemata and interpersonal schemata
6. Direct and indirect costs

Assessment of safety:
1. Death
2. Suicidal behaviour
3. Severe depressive symptom exacerbation

Secondary ID(s)

N/A

Source(s) of Monetary Support

German Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF; 01GV0618)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics Commitee of the Medical Faculty, University of Tuebingen; date of approval: 27 October 2006

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2008
URL:

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