Condition category
Mental and Behavioural Disorders
Date applied
04/12/2006
Date assigned
26/01/2007
Last edited
04/10/2007
Prospective/Retrospective
Retrospectively 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

Osianderstr. 24
Tuebingen
72076
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

POSITIVE

Study hypothesis

Cognitive Behavioural Treatment (CBT ) is more efficacious in reducing positive symptoms than Supportive Therapy (ST).

Ethics approval

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

Study design

Randomised, single blind, parallel group, prospective, controlled study comparing a specific treatment with an unspecific, “placebo”-attention control group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders)

Intervention

Cognitive Behavioural Treatment versus Supportive Therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

260

Participant exclusion criteria

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

Recruitment start date

01/01/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Osianderstr. 24
Tuebingen
72076
Germany

Sponsor information

Organisation

University Hospital Tuebingen (Germany)

Sponsor details

Geissweg 3
Tuebingen
72076
Germany

Sponsor type

University/education

Website

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

Funders

Funder type

Research organisation

Funder name

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

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

Publication citations

Additional files

Editorial Notes