Condition category
Mental and Behavioural Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
16/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.vispd.nl/projects.htm

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 measures

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

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

http://www.vispd.nl/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes