The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'
NCT ID: NCT06789380
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
358 participants
INTERVENTIONAL
2024-10-21
2028-12-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* legal incapacity
* Any mental state disorder that requires prior treatment
18 Years
ALL
No
Sponsors
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GGZ de Viersprong
UNKNOWN
Ggz Oost Brabant
OTHER
Stichting Altrecht GGZ
UNKNOWN
Stichting Dimence Group
UNKNOWN
Tilburg University
OTHER
Arkin
INDUSTRY
Responsible Party
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Principal Investigators
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Henricus L. Van, Dr.
Role: PRINCIPAL_INVESTIGATOR
Arkin NPI
Joost Hutsebaut, Prof. dr.
Role: STUDY_DIRECTOR
Tilburg University; GGZ de Viersprong
Nathan Bachrach, Dr.
Role: STUDY_CHAIR
Tilburg University; GGZ Oost-Brabant
Locations
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GGZ de Viersprong
Halsteren, North Brabant, Netherlands
GGZ Oost-Brabant
Helmond, North Brabant, Netherlands
Arkin NPI
Amsterdam, North Holland, Netherlands
Dimence Group
Almelo, Overijssel, Netherlands
Altrecht
Zeist, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Study website aimed at a broad audience.
Other Identifiers
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P-DAET NL86263.028.24 / P2409
Identifier Type: -
Identifier Source: org_study_id
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