Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06789380

The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'

Led by Arkin · Updated on 2025-02-05

358

Participants Needed

5

Research Sites

214 weeks

Total Duration

On this page

Sponsors

A

Arkin

Lead Sponsor

G

GGZ de Viersprong

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of 'severe' or 'extreme' personality disorder according to the alternative model for personality disorders
Not Eligible

You will not qualify if you...

  • IQ below 75
  • Legal incapacity
  • Any mental state disorder that requires prior treatment

AI-Screening

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Trial Site Locations

Total: 5 locations

1

GGZ de Viersprong

Halsteren, North Brabant, Netherlands

Actively Recruiting

2

GGZ Oost-Brabant

Helmond, North Brabant, Netherlands

Actively Recruiting

3

Arkin NPI

Amsterdam, North Holland, Netherlands, 1033NN

Actively Recruiting

4

Dimence Group

Almelo, Overijssel, Netherlands

Actively Recruiting

5

Altrecht

Zeist, Utrecht, Netherlands

Not Yet Recruiting

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Research Team

J

Jan Philipp Löffler, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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