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
Secondary identifying numbers NTR566; 3353 (ZonMW DO)
Submission date
14/02/2006
Registration date
14/02/2006
Last edited
18/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
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

Contact information

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

Study information

Study designMulticentre randomised single blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedPersonality Disorder
InterventionSchema-Focused Therapy (SFT) versus Treatment as Usual (TAU).
Intervention typeOther
Primary outcome measurePresence versus absence of Personality Disorder(s) (assessed with SCID-2 and ADP-IV [intermediate]).
Secondary outcome measures1. 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 study start date01/04/2006
Completion date01/04/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants250
Key inclusion criteria250 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 criteria1. 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 enrolment01/04/2006
Date of final enrolment01/04/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (UM) (Netherlands)
University/education

P.O. Box 616
Maastricht
6200 MD
Netherlands

ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan