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The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders: a Pragmatic Randomized Controlled Non-Inferiority Trial.'

Recruiting
18 years of age
Both
Phase N/A

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Overview

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-randomisation time points
  • undergo a semi-structured interview at 3 time points
  • follow treatment for personality disorders (either GIT-PD or MBT/ST)

Eligibility

Inclusion Criteria:

  • Patients who meet DSM-5 criteria for 'severe' or 'extreme' PD according to the alternative model for PDs, as assessed by the Semi-Structured Interview for Personality Functioning DSM-5 (STiP-5.1)

Exclusion Criteria:

  • IQ < 75 or legal incapacity
  • Any mental state disorder that requires prior treatment

Study details

Severe Personality Disorder

NCT06789380

Arkin

29 January 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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