No registrations found.
ID
Source
Brief title
Health condition
Schema-Focused Therapy (SFT) and Treatment as Usual (TAU)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence vs. absence of Personality Disorder(s) (assessed with SCID-2 and ADP-IV (intermediate)).
Secondary outcome
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);Quality of Life will be assessed with the 6. WHOQOL and the EuroQol.
Background summary
With 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.
Study objective
To 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).
Intervention
Schema-Focused Therapy (SFT) versus Treatment as Usual (TAU) and Client Centered Therapy according to Sachse (CCT).
P.O. Box 616
Lotte Bamelis
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881228
L.Bamelis@DMKEP.Unimaas.nl
P.O. Box 616
Lotte Bamelis
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881228
L.Bamelis@DMKEP.Unimaas.nl
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 DSM-IV criteria as first diagnosis.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL522 |
| NTR-old | NTR566 |
| Other | : 3353 (ZonMW DO) |
| ISRCTN | ISRCTN17752014 |