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
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