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

Официальное название

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.'

Обзор

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)

Вмешательства

• Поведенческое 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
• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0) [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]
• Semi-structured Interview for Personality Functioning (STiP-5.1) [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]

Вторичные конечные точки (8)

• Severity Indices of Personality Problems - Short Form (SIPP-SF) [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]
• Brief Symptom Inventory (BSI) [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]
• Columbia Suicide Severity Rating Scale Screen Version (C-SSRS) [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]
• SCID-5-PQ [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]
• WHO Disability Assessment Schedule (WHODAS 2.0) [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]
• EQ-5D-5L [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From enrollment to the follow-up assessment 30 months after the start of treatment.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 5 центров

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

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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