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Recruiting NCT06789380

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

No phase Interventional Severe Personality Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Schema therapy, Mentalization-based treatment, Guideline-informed treatment for personality disorders.
Who it may be relevant to
Registry conditions: Severe Personality Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The (Cost-)Effectiveness of Generalist (GIT-PD) Versus Specialist Treatment (MBT/ST) for Severe Personality Disorders (the P-DAET Study): a Pragmatic Randomized Controlled Non-Inferiority Trial.'

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

Interventions

  • Behavioral Schema therapy
    Schema therapy (ST) is an evidence-based, fully manualized, specialist form of psychotherapy for personality disorders (Bamelis et al., 2014; Sempértegui et al., 2013; Arntz et al., 2022). Eligible programs must adhere to the minimum standards described in the evidence-based literature. ST is an integrative treatment method, originally rooted in cognitive theory, but with additional influences from Gestalt, psychodynamic, and experiential methods. Schema therapy programs may differ in intensity
  • Behavioral Mentalization-based treatment
    Mentalization-based treatment (MBT) is an evidence-based, fully manualized, specialist form of psychotherapy for personality disorders (Bateman \& Fonagy, 2008; Bateman \& Fonagy, 2009; Laurenssen et al., 2018; Juul et al., 2023). MBT is rooted in psychodynamic and attachment theory and aims to alter personality pathology by improving mentalizing and enhancing epistemic trust. Eligible programs must adhere to the minimum standards described in the evidence-based literature. MBT programs may diff
  • Behavioral Guideline-informed treatment for personality disorders
    GIT-PD is a non-theoretical and non-methodological approach, based upon principles derived from common factors across evidence-based treatments for PD. GIT-PD has a flexible approach, enabling tailoring treatment to clinical needs of different types of patients. The treatment duration (start-end) is 12- 18 months. The treatment consists of three distinct phases. First, an assessment phase. Second, a modular treatment phase that offers either group or individual interventions. Third, a follow-up

Primary outcome measures

  • Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • Semi-structured Interview for Personality Functioning (STiP-5.1) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
Secondary outcome measures (8)
  • Severity Indices of Personality Problems - Short Form (SIPP-SF) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • Brief Symptom Inventory (BSI) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • Columbia Suicide Severity Rating Scale Screen Version (C-SSRS) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • SCID-5-PQ [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • WHO Disability Assessment Schedule (WHODAS 2.0) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • EQ-5D-5L [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]
  • Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P for Adults) [Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Netherlands · 5 centers
  • GGZ de Viersprong — Halsteren
  • GGZ Oost-Brabant — Helmond
  • Arkin NPI — Amsterdam
  • Dimence Group — Almelo
  • Altrecht — Zeist

Publications

  • Bomhof C, Loffler JP, Brugman S, Lodder P, van den End A, van Dijk MK, van Westen M, van Dam L, Wielaard I, Mensink W, Muskens L, de Moor B, Bachrach N, Van HL, Hutsebaut J. The effectiveness of generalist (GIT-PD) versus specialist treatment (MBT/ST) for severe personality disorders (Personality Disorders Access to Effective Treatment, P-DAET): study protocol of a pragmatic randomised controlled PMID 41267049

Identifiers

NCT: NCT06789380 · P-DAET NL86263.028.24 / P2409

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗