Clinical trial NCT06789380: The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'
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.'
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Personality Disorder
Keywords: generalist psychotherapy
specialist psychotherapy
personality disorder
AMPD
schema therapy
mentalisation-based treatment
guideline-informed treatment for personality disorders
level of personality functioning
alternative model of personality disorders
GIT-PD
MBT
ST
Lead sponsor: Arkin
Sponsor class: INDUSTRY
Collaborators: name: GGZ de Viersprong
name: Ggz Oost Brabant
name: Stichting Altrecht GGZ
name: Stichting Dimence Group
name: Tilburg University
First posted: 2025-01-23
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either group A or B.

Group A will receive the guideline-infomred treastment for personality disorders (GIT-PD).

Group B receives either mentalization-based treatment (MBT) or schema therapy (ST), depending on local availbility, treatment history and shared-decision making.
Primary purpose: TREATMENT

Brief summary: 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)


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

Primary outcomes:
measure: Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: Semi-structured Interview for Personality Functioning (STiP-5.1)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Secondary outcomes:
measure: Severity Indices of Personality Problems - Short Form (SIPP-SF)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: Brief Symptom Inventory (BSI)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: Columbia Suicide Severity Rating Scale Screen Version (C-SSRS)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: SCID-5-PQ
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: WHO Disability Assessment Schedule (WHODAS 2.0)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: EQ-5D-5L
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
measure: Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P for Adults)
timeFrame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Other outcomes:
measure: The Childhood Trauma Questionnaire - Short Form (CTQ-SF)
timeFrame: After enrollment at baseline, pre randomisation.
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: After enrollment at basline, pre randomisation.
measure: Autism Spectrum Quotient
timeFrame: After enrollment at baseline, pre randomisation.
measure: the subscale Motivation to Engage of the Treatment Motivation Scales for forensic outpatient treatment (TMS-F)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Self-Reflection and Insight Scale
timeFrame: After enrollment at baseline, pre randomisation.
measure: Locus of Control Scale (IE)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Mental Health Continuum - Short Form (MHC-SF)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Social Problems List from Improving Access to Psychological Therapies (IAPT)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Stigma of Immutability Scale (Wibbelink, 2022)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Dutch Reading Test for Adults (NLV)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Questionnaire Epistemic Trust (QET)
timeFrame: After enrollment at baseline, pre randomisation.
measure: Personality Inventory for DSM-5 - Short Form (PID-5-SF)
timeFrame: After enrollment at baseline, pre randomisation.
Locations:
city: Halsteren
country: Netherlands
facility: GGZ de Viersprong
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: GGZ Oost-Brabant
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Arkin NPI
state: Noord-Holland
city: Almelo
country: Netherlands
facility: Dimence Group
state: Overijssel
city: Zeist
country: Netherlands
facility: Altrecht
state: Utrecht
Study officials:
affiliation: Arkin NPI
name: Henricus L. Van, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tilburg University; GGZ de Viersprong
name: Joost Hutsebaut, Prof. dr.
role: STUDY_DIRECTOR
affiliation: Tilburg University; GGZ Oost-Brabant
name: Nathan Bachrach, Dr.
role: STUDY_CHAIR
References: