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

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.'

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)

Study Overview

• Status: Recruiting
• Conditions: Severe Personality Disorder
• Intervention / Treatment: Behavioral: Schema therapy; Behavioral: Mentalization-based treatment; Behavioral: Guideline-informed treatment for personality disorders

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Philipp Löffler, MSc; Phone Number: +31-020-590-4700; Email: j.p.loffler@tilburguniversity.edu

Study Locations

• Netherlands
  • Noord-Brabant
    • Halsteren, Noord-Brabant, Netherlands
      • Recruiting
      • GGZ de Viersprong
      • Contact: Joost Hutsebaut, Prof. dr.; Phone Number: +31-088-656-216; Email: Klantburo@deviersprong.nl
    • Helmond, Noord-Brabant, Netherlands
      • Recruiting
      • GGZ Oost-Brabant
      • Contact: Nathan Bachrach, Dr.; Phone Number: +31-088-846-04-60; Email: communicatie@ggzoostbrabant.nl
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1033NN
      • Recruiting
      • Arkin NPI
      • Contact: Henricus L. Van, Dr. phil.
      • Contact: Jan Philipp Löffler, MSc; Phone Number: +31-020-590-4700; Email: j.p.loffler@tilburguniversity.edu
  • Overijssel
    • Almelo, Overijssel, Netherlands
      • Recruiting
      • Dimence Group
      • Contact: Maarten van Dijk, Dr.; Phone Number: +31-0570-639-600; Email: persvoorlichting@dimencegroep.nl
  • Utrecht
    • Zeist, Utrecht, Netherlands
      • Not yet recruiting
      • Altrecht
      • Contact: Maarten van Westen, Dr.; Phone Number: +31-030-696-5100; Email: altrechtstart@altrecht.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Specialist Treatment for Severe Personality Disorders; 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.	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 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.; Other Names: Schema-focused therapy; SFT; 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 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.
Experimental: Generalist Treatment for Severe Personality Disorders; 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.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity Indices of Personality Problems - Short Form (SIPP-SF)	The SIPP-SF is a dimensional self-report questionnaire measuring the severity of personality pathology by assessing the core components of adaptive personality functioning. The SIPP-SF is designed in line with the concept of personality disorders as defined in the AMPD. Participants rate the 60 items on a 4-point scale ranging from fully disagree (1) to fully agree (4). 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.
Columbia Suicide Severity Rating Scale Screen Version (C-SSRS)	Suicidality is assessed using the C-SSRS. This self-report questionnaire covers 6 items and has been recommended by ICHOM as a standard outcome measurement in personality disorder research, due to its adequate psychometric properties (Prevolnik Rupel et al., 2021). The 6 items are answered with either 'yes' or 'no'. The total number of positive answers indicates suicide risk. 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.
SCID-5-PQ	The SCID-5-PQ (First et al., 2016) is a self-report measure assessing different criteria for DSM-5 personality disorders according to Section II. Participants are presented with 106 items describing whom they are as a person providing them with a dichotomous 'yes' or 'no' answer scheme. 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.
WHO Disability Assessment Schedule (WHODAS 2.0)	Social and professional functioning will be measured using the WHODAS 2.0 self-report questionnaire, which includes 12 items. This questionnaire has been recommended by ICHOM for its good reliability, adequate validity and high sensitivity to change (Prevolnik Rupel et al., 2021). Participants answer 12 questions across 6 domains on their daily functioning during the last 30 days. Answers across the 6 domains are weighted and summed to create a total score of disability ranging from 0 to 100. 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.
EQ-5D-5L	The EQ-5D-5L is a self-report questionnaire that covers 5 items measuring quality of life across 5 domains. Answer options consist of 5 levels ranging from 'no problems' to 'extreme problems'. The level indicates the health state for that domain and can be combined into a 5-digit number indicating the overall quality of life of the participant on that day. 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.
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)	The Q-LES-Q-SF is a self-report questionnaire consisting of 16 items.. Participants rate their satisfaction with different aspects of quality of life on a 5-point scale from "not at all or never" (1) to 'frequently or all the time" (5). The possible scores range from 14 to 70 with higher scores indicating greater satisfaction with life (Stevanovic, 2011). 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.
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P for Adults)	The TIC-P for Adults will be used to assess healthcare consumption and productivity loss during the last 3 months. Through 57 items the costs of different types of care are determined, e.g. for medication use, sessions with therapists, doctor's appointments and more indirect costs like loss of productivity and informal care by the participants network. The first section comprises 8 general questions. The second section includes 22 items regarding healthcare consumption. The last part consists of12 items on informal care and productivity loss. Some items feature multiple follow up questions resulting in the total number of 57 items. 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.
Brief Symptom Inventory (BSI)	The BSI is a self-report questionnaire investigating symptom severity, consisting of 53 items which can be answered using a scale ranging from 1 (not at all) to 5 (extremely). The total score represents the number of symptoms that participants experienced during the past week. A global severity index and sub scores on all 9 domains are calculated by summing the values on all items and dividing by the number of items/domains. 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Childhood Trauma Questionnaire - Short Form (CTQ-SF)	The CTQ-SF employs 25 items to assess childhood trauma and distinguish between emotional neglect, physical neglect, emotional abuse, physical abuse and sexual abuse (Bernstein et al., 2003). All statements start with "When I was growing up..." and are answered on a 5-point scale ranging from 1 (never true) to 5 (very often true). 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.	After enrollment at baseline, pre randomisation.
PTSD Checklist for DSM-5 (PCL-5)	The PCL-5 aims to screen for post-traumatic stress disorder using 20 items that correspond to the DSM-5 criteria (Blevins et al., 2015). Likewise, the four subscales correspond to the DSM-5's clusters B through E for PTSD. The 20 items are answered on a 4-point scale ranging from 0 (not at all) to 4 (extremely) resulting in scores ranging between 0 and 80. 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.	After enrollment at basline, pre randomisation.
Autism Spectrum Quotient	The 5-item version of the Autism Spectrum Quotient (AQ-5) is a very brief screener, which has been derived from the AQ-10. The AQ-5 measures social communication deficits, corresponding to Criterion A of the ASD-diagnosis. The scale has acceptable internal consistency and convergent validity. Items are rated on a 4 point scale ranging from 'definitely disagree' to 'definitely agree'. 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.	After enrollment at baseline, pre randomisation.
the subscale Motivation to Engage of the Treatment Motivation Scales for forensic outpatient treatment (TMS-F)	Patient commitment to treatment is measured with a selection of items from the subscale Motivation to Engage of the TMS-F. The four items can be rated on a 7-point Likert scale . 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.	After enrollment at baseline, pre randomisation.
Self-Reflection and Insight Scale	A modified version of the SRIS is used to assess self- reflection and insight. The SRIS contains 20 5-point Likert scale items ranging from 1 (strongly disagree) to 5 (strongly agree). 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.	After enrollment at baseline, pre randomisation.
Locus of Control Scale (IE)	Internal locus of control, defined as the extent to which a person experiences an outcome as the result of their own behavior or personal characteristics rather than external circumstance, is assessed by the Locus of Control scale (IE) . The IE contains 10 5-point Likert scale items. 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.	After enrollment at baseline, pre randomisation.
Mental Health Continuum - Short Form (MHC-SF)	The MHC-SF was developed by Keyes (2008) to measure hedonic and eudaimonic well-being, which can be seen as a separate, but related, dimension to mental "ill-being" (Franken et al., 2018; Keyes, 2007). The questionnaire contains 14 items and three dimensions: emotional well-being (3 items), psychological well-being (6 items) and social well-being (5 items). 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.	After enrollment at baseline, pre randomisation.
Social Problems List from Improving Access to Psychological Therapies (IAPT)	By using the social problems list, derived from the (IAPT) program social problems (e.g., financial problems, housing problem, and unemployment) are assessed (Clark, 2011). 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.	After enrollment at baseline, pre randomisation.
Multidimensional Scale of Perceived Social Support (MSPSS)	The MSPSS (O'Toole et al 2012) is assessed to investigate perceived support from three sources: significant others, family, and friends. The MSPSS contains 12 items which can be rated on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree). 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.	After enrollment at baseline, pre randomisation.
Stigma of Immutability Scale (Wibbelink, 2022)	PD has been associated to stigma of immutability (Aviram 2006) and we will use the five items scale as developed by Wibbelink et al (2022), measuring the extent to which participants believe that PD is resistant to treatment. 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.	After enrollment at baseline, pre randomisation.
Dutch Reading Test for Adults (NLV)	Verbal Intelligence will be measured by the Dutch Reading Test for Adults ('NLV'). Psychometric properties have been shown to be satisfactory among various populations (Hermans et al., 2022). 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.	After enrollment at baseline, pre randomisation.
Questionnaire Epistemic Trust (QET)	By administering the 24-item QET, insight is gained into a person's developmental capacity to accept information as authentic, trustworthy, generalizable and relevant to the self (i.e. epistemic trust; Knapen et al., 2023). The instrument sheds light on four factors, referring to hypervigilance, curiosity/openness, expectation of help and openness to help. 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.	After enrollment at baseline, pre randomisation.
Personality Inventory for DSM-5 - Short Form (PID-5-SF)	The PID-5-SF is a shortened 100 item version of the original PID-5 (Maples et al., 2015). It measures 25 facets across 5 domains of pathological personality traits, which corresponds to criterium B of the AMPD (American Psychiatric Association, 2022). 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.	After enrollment at baseline, pre randomisation.

Collaborators and Investigators

• Sponsor: Arkin
• Collaborators: Tilburg University; Ggz Oost Brabant; GGZ de Viersprong; Stichting Altrecht GGZ; Stichting Dimence Group
• Investigators: 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

Publications and helpful links

Helpful Links

• Study website aimed at a broad audience.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: personality disorder; MBT; schema therapy; generalist psychotherapy; specialist psychotherapy; AMPD; mentalisation-based treatment; guideline-informed treatment for personality disorders; level of personality functioning; alternative model of personality disorders; GIT-PD; ST
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders
• Other Study ID Numbers: P-DAET NL86263.028.24 / P2409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No