Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Helene Andrea
ORCID ID
Contact details
Viersprong Institute for Studies on Personality Disorders (VISPD)
P.O. Box 7
Halsteren
4660 AA
Netherlands
+31 (0)16 463 2200
helene.andrea@deviersprong.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SCEPTRE
Study hypothesis
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
Approval received from the Research Ethics Committee (REC) of Erasmus Medical Centre, Rotterdam, on the 7th January 2004 (ref: MEC 229.834/2003/122).
Study design
Non-randomised clinical trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/09/2003
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
821
Participant exclusion criteria
1. Insufficient command of Dutch language
2. Severe cognitive impairments
3. Mental retardation
4. Axis-I schizophrenia
Recruitment start date
01/09/2003
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Viersprong Institute for Studies on Personality Disorders (VISPD)
Halsteren
4660 AA
Netherlands
Sponsor information
Organisation
Viersprong Institute for Studies on Personality Disorders (VISPD) (The Netherlands)
Sponsor details
P.O. Box 7
Halsteren
4660 AA
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Psychotherapeutic Center De Viersprong (The Netherlands)
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
Basic results (scientific)
Publication list