NCT06789380 The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'
| NCT ID | NCT06789380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arkin |
| Condition | Severe Personality Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 358 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 358 participants in total. It began in 2024-10-21 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to investigate if generalist treatment (GIT-PD) is non-inferior in improving level op personality functioning compared to specialist treatment (MBT/ST) in patients with severe personality disorders. The main questions it aims to answer are: 1. Is generalist treatment (GIT-PD) non-inferior in improving level of personality functioning compared to specialist treatment (MBT/ST) in patients suffering from severe personality disorders (PD)? 2. What patient characteristics predict which patients will benefit more from specialist or generalist treatment? Participants will be randomized to either specialist or generalist treatment. Interventions included in specialist treatment are Mentalization-Based Treatment (MBT) and Schema Therapy (ST). Generalist treatment will be offererd following the principles of the Guideline-Informed Treatment for Personality Disorders (GIT-PD), a principle-driven treatment framework based upon common factors and allowing personalized treatment according to patients' needs. All participating institutions offer GIT-PD and MBT and/or ST. Before, during and after following this treatment participants will complete measurements at 8 distinct time points. Participants will be asked to: * complete a range of instruments at baseline to enable the construction of a personalized advantage index to predict treatment response based on patient characteristics * complete questionnaires at all 7 post-randomization time points * undergo a semi-structured interview at 3 time points * follow treatment for personality disorders (either GIT-PD or MBT/ST)
Eligibility 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
Contact & Investigator
Henricus L. Van, Dr.
PRINCIPAL INVESTIGATOR
Arkin NPI
Frequently Asked Questions
Who can join the NCT06789380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Personality Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06789380 currently recruiting?
Yes, NCT06789380 is actively recruiting participants. Contact the research team at J.P.Loffler@tilburguniversity.edu for enrollment information.
Where is the NCT06789380 trial being conducted?
This trial is being conducted at Halsteren, Netherlands, Helmond, Netherlands, Amsterdam, Netherlands, Almelo, Netherlands and 1 additional location.
Who is sponsoring the NCT06789380 clinical trial?
NCT06789380 is sponsored by Arkin. The principal investigator is Henricus L. Van, Dr. at Arkin NPI. The trial plans to enroll 358 participants.