Cognitive behavioural treatment for persistent positive symptoms in psychotic disorders
ISRCTN | ISRCTN29242879 |
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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
Scientific
Osianderstr. 24
Tuebingen
72076
Germany
Study information
Study design | Randomised, single blind, parallel group, prospective, controlled study comparing a specific treatment with an unspecific, placebo-attention control group |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | - |
Study acronym | POSITIVE |
Study objectives | Cognitive 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) studied | Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders) |
Intervention | Cognitive Behavioural Treatment versus Supportive Therapy |
Intervention type | Other |
Primary outcome measure | 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 study start date | 01/01/2007 |
Completion date | 31/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 260 |
Total final enrolment | 233 |
Key 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 |
Key exclusion criteria | 1. Substance abuse or substance dependence as primary clinical problem 2. Organic brain disease |
Date of first enrolment | 01/01/2007 |
Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Osianderstr. 24
Tuebingen
72076
Germany
72076
Germany
Sponsor information
University Hospital Tuebingen (Germany)
University/education
University/education
Geissweg 3
Tuebingen
72076
Germany
Website | http://www.medizin.uni-tuebingen.de |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not 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.