The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'
P-DAET
1 other identifier
interventional
358
1 country
5
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:
- 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2024
CompletedFirst Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 5, 2025
February 1, 2025
4.1 years
January 17, 2025
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
The LPFS-BF 2.0 is a self-report questionnaire consisting of 12 items (Weekers et al., 2018). Each item reflects a basic underlying impairment related to the 12 features of personality functioning according to Criterium A of the AMPD such as identity, self-direction, intimacy and relational functioning. The LPFS-BF 2.0 offers a severity index for personality pathology making it suitable for measuring treatment effects. Each item is scored on a scale from 1 (=very false or often false) to 4 (=very true or often true). Therefore, participants achieve a total score between 12 and 48 representing the severity of impairment in personality functioning. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
From enrollment to the follow-up assessment 30 months after the start of treatment.
Semi-structured Interview for Personality Functioning (STiP-5.1)
The STiP-5.1 is a semi-structured clinical interview that provides a multi-item assessment of the severity of personality impairments according to the Level of Personal Functioning Scale (LPFS) of the AMPD included in Section III of DSM-5 (APA, 2013). The interviewer should rate the severity of each facet on a scale ranging between 'little to no impairment' (0) to 'extreme impairment' (4). It takes 45 minutes on average to administer the interview. A total score between 0 and 48 is given to indicate the participants global level of personality functioning . We administer the STiP-5.1 at 3 distinct time points. At the start and end of treatment and after 1 year follow up. All interviews are done by blinded research assistants, and the scores are directly logged in Castor. Interviews will be done either face to face or via video call.
From enrollment to the follow-up assessment 30 months after the start of treatment.
Secondary Outcomes (8)
Severity Indices of Personality Problems - Short Form (SIPP-SF)
From enrollment to the follow-up assessment 30 months after the start of treatment.
Brief Symptom Inventory (BSI)
From enrollment to the follow-up assessment 30 months after the start of treatment.
Columbia Suicide Severity Rating Scale Screen Version (C-SSRS)
From enrollment to the follow-up assessment 30 months after the start of treatment.
SCID-5-PQ
From enrollment to the follow-up assessment 30 months after the start of treatment.
WHO Disability Assessment Schedule (WHODAS 2.0)
From enrollment to the follow-up assessment 30 months after the start of treatment.
- +3 more secondary outcomes
Other Outcomes (13)
The Childhood Trauma Questionnaire - Short Form (CTQ-SF)
After enrollment at baseline, pre randomisation.
PTSD Checklist for DSM-5 (PCL-5)
After enrollment at basline, pre randomisation.
Autism Spectrum Quotient
After enrollment at baseline, pre randomisation.
- +10 more other outcomes
Study Arms (2)
Specialist Treatment for Severe Personality Disorders
ACTIVE COMPARATORParticipants 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.
Generalist Treatment for Severe Personality Disorders
EXPERIMENTALParticipants 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.
Interventions
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 and duration, even at the same site, but must include a minimum of either 40 sessions and/or a duration of 12 to 24 months. In addition, in order to be eligible, a schema therapy program must be of higher intensity or longer duration than the generalist treatment (GIT-PD) offered at the same site.
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 differ in intensity and duration, even at the same site, but must include a minimum of either 40 sessions or a duration of 12 to 24 months. In additon, in order to be eligible, an MBT program must be of higher intensity or longer duration than the generalist treatment (GIT-PD) offered at the same site.
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 phase with limited treatment and focus on relapse prevention. In order to be eligible, GIT-PD should be less intensive than specialist psychotherapies offered in the control arm at the same location (i.e. MBT or ST). GIT-PD will not include evidence-based psychotherapy for personality disorders as described in previous RCTs.
Eligibility Criteria
You may qualify if:
- 'severe' or 'extreme' personality disorder (PD) according to the alternative model for PDs
You may not qualify if:
- IQ \< 75
- legal incapacity
- Any mental state disorder that requires prior treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arkinlead
- GGZ de Viersprongcollaborator
- Ggz Oost Brabantcollaborator
- Stichting Altrecht GGZcollaborator
- Stichting Dimence Groupcollaborator
- Tilburg Universitycollaborator
Study Sites (5)
GGZ de Viersprong
Halsteren, North Brabant, Netherlands
GGZ Oost-Brabant
Helmond, North Brabant, Netherlands
Arkin NPI
Amsterdam, North Holland, 1033NN, Netherlands
Dimence Group
Almelo, Overijssel, Netherlands
Altrecht
Zeist, Utrecht, Netherlands
Related Publications (1)
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 non-inferiority multicentre trial. BMC Psychiatry. 2025 Nov 20;25(1):1107. doi: 10.1186/s12888-025-07550-4.
PMID: 41267049DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henricus L. Van, Dr.
Arkin NPI
- STUDY DIRECTOR
Joost Hutsebaut, Prof. dr.
Tilburg University; GGZ de Viersprong
- STUDY CHAIR
Nathan Bachrach, Dr.
Tilburg University; GGZ Oost-Brabant
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
January 23, 2025
Study Start
October 21, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
February 5, 2025
Record last verified: 2025-02