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).
ID
Bron
Verkorte titel
Aandoening
Schema-Focused Therapy (SFT) and Treatment as Usual (TAU)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Presence vs. absence of Personality Disorder(s) (assessed with SCID-2 and ADP-IV (intermediate)).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksproduct en/of interventie
Schema-Focused Therapy (SFT) versus Treatment as Usual (TAU) and Client Centered Therapy according to Sachse (CCT).
Publiek
P.O. Box 616
Lotte Bamelis
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881228
L.Bamelis@DMKEP.Unimaas.nl
Wetenschappelijk
P.O. Box 616
Lotte Bamelis
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881228
L.Bamelis@DMKEP.Unimaas.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL522 |
NTR-old | NTR566 |
Ander register | : 3353 (ZonMW DO) |
ISRCTN | ISRCTN17752014 |