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

Arkin

Status: Enrolling

Conditions: Severe Personality Disorder

Treatments: Behavioral: Schema therapy; Behavioral: Mentalization-based treatment; Behavioral: Guideline-informed treatment for personality disorders

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06789380

P-DAET NL86263.028.24 / P2409

Details and patient eligibility

About

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)

Enrollment: 358 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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358 participants in 2 patient groups

Specialist Treatment for Severe Personality Disorders

Active Comparator group

Description:

Participants will receive specialist treatment for severe personality disorders. Specifically, the type of treatment will be either mentalization-based treatment (MBT) or schema therapy (ST), depending on local availbility, treatment history and shared-decision making. Both MBT and ST must adhere to the protocol and minimum dosage described in respective effect studies published on MBT or ST.

Treatment:

Behavioral: Mentalization-based treatment

Behavioral: Schema therapy

Generalist Treatment for Severe Personality Disorders

Experimental group

Description:

Participants will receive a generalist treatment for severe personality disorders. Specificially, the Guideline-Informed Treatment for Personality Disorders (GIT-PD). Sites can only participate in this study, if they offer a GIT-PD programme of lower dosage than the specialist intervention offered at the same site.

Treatment:

Behavioral: Guideline-informed treatment for personality disorders