Cognitive behavioural treatment for persistent positive symptoms in psychotic disorders

ISRCTN ISRCTN29242879
DOI https://doi.org/10.1186/ISRCTN29242879
Secondary identifying numbers N/A
Submission date
04/12/2006
Registration date
26/01/2007
Last edited
01/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stefan Klingberg
Scientific

Osianderstr. 24
Tuebingen
72076
Germany

Study information

Study designRandomised, single blind, parallel group, prospective, controlled study comparing a specific treatment with an unspecific, “placebo”-attention control group
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title-
Study acronymPOSITIVE
Study objectivesCognitive Behavioural Treatment (CBT ) is more efficacious in reducing positive symptoms than Supportive Therapy (ST).
Ethics approval(s)Ethics Commitee of the Medical Faculty, University of Tuebingen; date of approval: 27 October 2006
Health condition(s) or problem(s) studiedPsychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders)
InterventionCognitive Behavioural Treatment versus Supportive Therapy
Intervention typeOther
Primary outcome measurePrimary endpoint for efficacy: PANSS positive syndrome (sum of items P1-P7), assessed post treatment (T9).
Secondary outcome measuresKey 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 study start date01/01/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants260
Total final enrolment233
Key inclusion criteria1. 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
Key exclusion criteria1. Substance abuse or substance dependence as primary clinical problem
2. Organic brain disease
Date of first enrolment01/01/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Osianderstr. 24
Tuebingen
72076
Germany

Sponsor information

University Hospital Tuebingen (Germany)
University/education

Geissweg 3
Tuebingen
72076
Germany

Website http://www.medizin.uni-tuebingen.de
ROR logo "ROR" https://ror.org/00pjgxh97

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article secondary analysis 10/02/2020 12/02/2020 Yes No
Results article secondary analysis 23/11/2020 25/11/2020 Yes No

Editorial Notes

01/11/2022: Total final enrolment added.
25/11/2020: Publication reference added.
12/02/2020: Publication reference added.