Psychological treatment of Personality Disorders: A multi-centered randomised controlled trial on the (cost-)effectiveness of Schema-Focused Therapy
ISRCTN | ISRCTN17752014 |
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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
Scientific
University Maastricht (UM)
DMKEP
P.O. Box 616
Maastricht
6200 MD
Netherlands
Phone | +31 (0)43 3881228 |
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L.Bamelis@DMKEP.Unimaas.nl |
Study information
Study design | Multicentre randomised single blind active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
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 | Presence versus absence of Personality Disorder(s) (assessed with SCID-2 and ADP-IV [intermediate]). |
Secondary outcome measures | 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 |
Overall study start date | 01/04/2006 |
Completion date | 01/04/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht (UM)
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
University Maastricht (UM) (Netherlands)
University/education
University/education
P.O. Box 616
Maastricht
6200 MD
Netherlands
https://ror.org/02jz4aj89 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw)
Private sector organisation / Other non-profit organizations
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |