Psychological treatment of Personality Disorders: A multi-centered randomised controlled trial on the (cost-)effectiveness of Schema-Focused Therapy

ISRCTN	ISRCTN17752014
DOI	https://doi.org/10.1186/ISRCTN17752014
Protocol serial number	NTR566; 3353 (ZonMW DO)
Sponsor	University Maastricht (UM) (Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw)

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

Dr Lotte Bamelis
Scientific

University Maastricht (UM)
DMKEP
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3881228
Email	L.Bamelis@DMKEP.Unimaas.nl

Primary study design	Interventional
Study design	Multicentre randomised single blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Personality Disorder
Intervention	Schema-Focused Therapy (SFT) versus Treatment as Usual (TAU).
Intervention type	Other
Primary outcome measure(s)	Presence versus absence of Personality Disorder(s) (assessed with SCID-2 and ADP-IV [intermediate]).
Key secondary outcome measure(s)	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
Completion date	01/04/2010

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	250
Key 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.
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	01/04/2010

University Maastricht (UM)

Maastricht
6200 MD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan