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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArkin

About this 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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

IQ < 75

legal incapacity

Any mental state disorder that requires prior treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Schema therapy

    Behavioral

    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

    Behavioral

    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.

  • Guideline-informed treatment for personality disorders

    Behavioral

    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.

Treatment groups

358 Participants
are divided into 2 treatment groups
Group A: Specialist Treatment for Severe Personality DisordersActive comparator 2 interventions
Group B: Generalist Treatment for Severe Personality DisordersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the follow-up assessment 30 months after the start of treatment.
2

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.

Time frame
From enrollment to the follow-up assessment 30 months after the start of treatment.

Secondary outcomes

1

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.

Time frame
From enrollment to the follow-up assessment 30 months after the start of treatment.
2

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.

Time frame
From enrollment to the follow-up assessment 30 months after the start of treatment.
3

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.

Time frame
From enrollment to the follow-up assessment 30 months after the start of treatment.
4

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.

Time frame
From enrollment to the follow-up assessment 30 months after the start of treatment.

Other outcomes

1

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.

Time frame
After enrollment at baseline, pre randomisation.
2

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.

Time frame
After enrollment at basline, pre randomisation.
3

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.

Time frame
After enrollment at baseline, pre randomisation.
4

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.

Time frame
After enrollment at baseline, pre randomisation.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arkin

Lead sponsor

GGZ de Viersprong

Collaborator

Ggz Oost Brabant

Collaborator

Stichting Altrecht GGZ

Collaborator

Stichting Dimence Group

Collaborator

Tilburg University

Collaborator