Study on Cost-Effectiveness of Personality disorder TREatment
| ISRCTN | ISRCTN73817429 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73817429 | 
| Secondary identifying numbers | N/A | 
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 16/01/2007
- 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
        
    
                    
                        
    
        
            
            Record updated in last year
        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr Helene Andrea 
Scientific
                                        Scientific
                                                Viersprong Institute for Studies on Personality Disorders (VISPD)
P.O. Box 7
Halsteren
4660 AA
Netherlands
                                                
| Phone | +31 (0)16 463 2200 | 
|---|---|
| helene.andrea@deviersprong.nl | 
Study information
| Study design | Non-randomised clinical trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Multi-centre | 
| Study setting(s) | Not specified | 
| Study type | Treatment | 
| Scientific title | |
| Study acronym | SCEPTRE | 
| Study objectives | 1. Effect sizes of the psychotherapeutic treatments vary between 0.5 and 2.0. 2. A lower dosage of psychotherapeutic treatment is mainly related to symptomatic improvement, while a higher dosage is also related to structural and functional improvement. 3. The dosage for an optimal cost-effectiveness is lower than the maximum dosage. 4. When compared to cluster B personality disorders, for cluster C personality disorders a lower dosage is required to reach optimal cost-effectiveness. 5. A lower level of psychological mindedness and/or ability for a positive working alliance with the therapist is related to a lower level of (cost)-effectiveness. | 
| Ethics approval(s) | Approval received from the Research Ethics Committee (REC) of Erasmus Medical Centre, Rotterdam, on the 7th January 2004 (ref: MEC 229.834/2003/122). | 
| Health condition(s) or problem(s) studied | Personality Disorder | 
| Intervention | Psychotherapeutic treatment programs for patients with personality pathology that will be distinguished from one another according to the following dosages: 1. Short (maximum of six months) outpatient 2. Short day hospital 3. Short inpatient 4. Long (at least six months) outpatient 5. Long day hospital 6. Long inpatient | 
| Intervention type | Other | 
| Primary outcome measure | 1. Structural improvement of personality pathology (assessed with the Outcome Questionnaire [OQ45], and the Severity Indices of Personality Problems [SIPP]) 2. Quality Adjusted Life Years (QALYs) | 
| Secondary outcome measures | 1. Symptomatic improvement (assessed with the Symptoms CheckList [SCL-90]) 2. Functional improvement (assessed with, amongst others, questions regarding work situation and care consumption) 3. Quality of life | 
| Overall study start date | 01/09/2003 | 
| Completion date | 31/12/2008 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | Not Specified | 
| Target number of participants | 821 | 
| Key inclusion criteria | 1. At least one Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) axis-II diagnosis 2. An indication for psychotherapeutic treatment aiming at structural improvement of the personality pathology (besides symptomatic and/or functional improvement) | 
| Key exclusion criteria | 1. Insufficient command of Dutch language 2. Severe cognitive impairments 3. Mental retardation 4. Axis-I schizophrenia | 
| Date of first enrolment | 01/09/2003 | 
| Date of final enrolment | 31/12/2008 | 
Locations
Countries of recruitment
- Netherlands
Study participating centre
                                            Viersprong Institute for Studies on Personality Disorders (VISPD)
                                        
                                        
                                            
                                            Halsteren
4660 AA
Netherlands
                                    4660 AA
Netherlands
Sponsor information
                                            Viersprong Institute for Studies on Personality Disorders (VISPD) (The Netherlands)
Research organisation
                                        Research organisation
                                                P.O. Box 7
Halsteren
4660 AA
Netherlands
                                                
| Website | http://www.vispd.nl/ | 
|---|---|
| https://ror.org/048jnwk41 | 
Funders
Funder type
Hospital/treatment centre
                                                Psychotherapeutic Center De Viersprong (The Netherlands)
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | 

