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

Last updated: February 3, 2025
Sponsor: Arkin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Schizotypal Personality Disorder (Spd)

Treatment

Guideline-informed treatment for personality disorders

Schema therapy

Mentalization-based treatment

Clinical Study ID

NCT06789380
P-DAET NL86263.028.24 / P2409
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • 'severe' or 'extreme' personality disorder (PD) according to the alternative modelfor PDs

Exclusion

Exclusion Criteria:

  • IQ < 75

  • legal incapacity

  • Any mental state disorder that requires prior treatment

Study Design

Total Participants: 358
Treatment Group(s): 3
Primary Treatment: Guideline-informed treatment for personality disorders
Phase:
Study Start date:
October 21, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • GGZ de Viersprong

    Halsteren, Noord-Brabant
    Netherlands

    Active - Recruiting

  • GGZ Oost-Brabant

    Helmond, Noord-Brabant
    Netherlands

    Active - Recruiting

  • Arkin NPI

    Amsterdam, Noord-Holland 1033NN
    Netherlands

    Active - Recruiting

  • Dimence Group

    Almelo, Overijssel
    Netherlands

    Active - Recruiting

  • Altrecht

    Zeist, Utrecht
    Netherlands

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.