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


- candidate number1925
- NTR NumberNTR566
- ISRCTNISRCTN17752014
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-feb-2006
- Date Registered NTR17-jan-2006
- Secondary IDs3353 (ZonMW DO) 
- Public TitlePsychological treatment of Personality Disorders: A multi-centered randomised controlled trial on the (cost-)effectiveness of Schema-Focused Therapy.
- Scientific TitlePsychological treatment of Personality Disorders: A multi-centered randomised controlled trial on the (cost-)effectiveness of Schema-Focused Therapy.
- ACRONYMN/A
- hypothesisTo assess the (cost-)effectiveness of Schema-Focused Therapy (SFT) compared to Treatment as Usual (TAU) and Client Centered Therapy according to Sachse (CCT) as treatment for 6 Personality Disorders (PDs).
- Healt Condition(s) or Problem(s) studiedPersonality disorder
- Inclusion criteria250 outpatients of mental health institutes in the Netherlands with a cluster-C PD, a narcissistic, histrionic or paranoid PD as defined by DSM-IV criteria as first diagnosis.
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-apr-2006
- planned closingdate1-apr-2010
- Target number of participants250
- InterventionsSchema-Focused Therapy (SFT) versus Treatment as Usual (TAU) and Client Centered Therapy according to Sachse (CCT).
- Primary outcomePresence vs. absence of Personality Disorder(s) (assessed with SCID-2 and ADP-IV (intermediate)).
- Secondary outcome1. 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);Quality of Life will be assessed with the 6. WHOQOL and the EuroQol.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Lotte Bamelis
- CONTACT for SCIENTIFIC QUERIES Arnoud Arntz
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryWith a Multi-Centered Randomized Controlled Trial with pre-post assessments the (cost-)effectiveness of Schema-Focused Therapy (SFT) compared to Treatment as Usual (TAU) and Client Centered Therapy according to Sachse (CCT) will be assessed as treatment for 6 Personality Disorders (PDs). 250 outpatients of mental health institutes in the Netherlands with a cluster-C, narcissistic, histrionic or paranoid PD as defined by DSM-IV criteria as first diagnosis will be recruited. The primary outcome measure is recovery of PDs as assessed with the SCID-2 interview. Secondary outcome measures include Quality of Life, general psychopathology complaints, axis-1 diagnoses, personality measures, social functioning, global functioning (GAF score DSM-IV). Power/data analysis: N = 100 per condition suffices to demonstrate with power = 90% (2-tailed test) a difference between TAU and SFT in % recovered patients of 23.8% vs. 45.5 % (odds ratio = 2.667) which is expected on the basis of experiences with open trials and the BPD trial. (N = 250 includes a 18% study drop-out). Data-analyses will be done by survival analysis and logistic regression (primary outcome) and MANOVA (secondary outcome measures). Both an intention-to-treat and a completers analysis will be done. For the economic evaluation a combined cost-effectiveness/cost-utility analysis will be performed from a societal perspective.
- Main changes (audit trail)
- RECORD17-jan-2006 - 8-nov-2007


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