Comparing generalist and specialist treatments for severe personality disorders
The (Cost-)Effectiveness of Generalist (GIT-PD) Versus Specialist Treatment (MBT/ST) for Severe Personality Disorders (the P-DAET Study): a Pragmatic Randomized Controlled Non-Inferiority Trial.'
This study is testing whether a general treatment approach is just as helpful as specialized therapy for people with severe personality disorders.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arkin Industry-sponsored |
| Locations | 5 sites (Halsteren, North Brabant and 4 other locations) |
| Trial ID | NCT06789380 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether generalist treatment (GIT-PD) is as effective as specialist treatment (Mentalization-Based Treatment and Schema Therapy) in improving personality functioning in patients with severe personality disorders. Participants will be randomly assigned to receive either generalist or specialist treatment. The study also aims to identify patient characteristics that predict which treatment may be more beneficial for individual patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with severe or extreme personality disorders according to the alternative model for personality disorders.
Not a fit: Patients with an IQ below 75, legal incapacity, or those requiring prior treatment for any mental state disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with severe personality disorders.
How similar studies have performed: Other studies have explored the effectiveness of generalist versus specialist treatments, but this specific comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 'severe' or 'extreme' personality disorder (PD) according to the alternative model for PDs Exclusion Criteria: * IQ \< 75 * legal incapacity * Any mental state disorder that requires prior treatment
Where this trial is running
Halsteren, North Brabant and 4 other locations
- GGZ de Viersprong — Halsteren, North Brabant, Netherlands (Recruiting)
- GGZ Oost-Brabant — Helmond, North Brabant, Netherlands (Recruiting)
- Arkin NPI — Amsterdam, North Holland, Netherlands (Recruiting)
- Dimence Group — Almelo, Overijssel, Netherlands (Recruiting)
- Altrecht — Zeist, Utrecht, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Henricus L. Van, Dr. — Arkin NPI
- Study coordinator: Jan Philipp Löffler, MSc
- Email: J.P.Loffler@tilburguniversity.edu
- Phone: +31-020-590-4700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.