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

Study acronym: P-DAET
StatusRecruiting
PhaseNot applicable
SponsorArkin
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 16 words Secondary endpoints: details revised at 1 of 8 entries · Site details revised at 5 of 5 sites · Study title shortened, about 6 wordsv2 Show 3 more changesShow less
    • Secondary endpoints: details revised at 1 of 8 entries
    • Site details revised at 5 of 5 sites
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Arkin
2 trials monitored
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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)
Trial Details
NCT Number NCT06789380
Lead Sponsor Arkin
Collaborators: GGZ de Viersprong, Ggz Oost Brabant, Stichting Altrecht GGZ, Stichting Dimence Group, Tilburg University
Conditions Severe Personality Disorder
Enrollment 358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov