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
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