Condition category
Mental and Behavioural Disorders
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
18/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lotte Bamelis

ORCID ID

Contact details

University Maastricht (UM)
DMKEP
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881228
L.Bamelis@DMKEP.Unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR566; 3353 (ZonMW DO)

Study information

Scientific title

Acronym

Study hypothesis

To assess the (cost-)effectiveness of Schema-Focused Therapy (SFT) compared to Treatment as Usual (TAU) as treatment for six Personality Disorders (PDs).

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised single blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Personality Disorder

Intervention

Schema-Focused Therapy (SFT) versus Treatment as Usual (TAU).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Presence versus absence of Personality Disorder(s) (assessed with SCID-2 and ADP-IV [intermediate]).

Secondary outcome measures

1. Axis-1 diagnoses (assessed with the SCID-1)
2. General psychopathological symptoms (assessed with the SCL-90)
3. PD-related schemas and beliefs (assessed with the Young Schema Questionnaire [YSQ] and the PD-Belief Questionnaire [PDBQ, Arntz et al., 2004])
4. Social functioning will be assessed with the WSAS
5. Independent raters will assess global functioning with the GAF Scale (DSM-IV)
6. Quality of Life will be assessed with the WHOQOL and the EuroQol

Overall trial start date

01/04/2006

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

250 outpatients of mental health institutes in the Netherlands with a cluster-C PD, a narcissistic, histrionic or paranoid PD as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as first diagnosis.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

250

Participant exclusion criteria

1. IQ less than 80
2. Problems with Dutch language (talking, reading, writing)
3. Borderline, antisocial, schizoid, schizotypal personality disorder
4. Psychotic or bipolar disorder on axis-I, DSM-IV
5. Substance dependence needing clinical detoxification (after detoxification this is no longer an exclusion criterion)
6. Immediate suicide risk

Recruitment start date

01/04/2006

Recruitment end date

01/04/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (Netherlands)

Sponsor details

P.O. Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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