Severe Personality DisorderP-DAETNCT06789380
The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'
A study testing Schema therapy, Mentalization-based treatment and Guideline-informed treatment for personality disorders in people with Severe Personality Disorder, run by Arkin at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Personality Disorder
- What is being tested?
- Schema therapy, Mentalization-based treatment and Guideline-informed treatment for personality disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 5 sitesNetherlands
- Study dates
- 21 Oct 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 'severe' or 'extreme' personality disorder (PD) according to the alternative model for PDs
Who cannot join
- IQ < 75
- legal incapacity
- Any mental state disorder that requires prior treatment
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Dimence Group
Almelo, Overijssel
Maarten van Dijk, Dr., +31-0570-639-600, persvoorlichting@dimencegroep.nl
- Recruiting
Arkin NPI
Amsterdam, North Holland, 1033NN
Jan Philipp Löffler, MSc, +31-020-590-4700, j.p.loffler@tilburguniversity.edu
Henricus L. Van, Dr. phil.
- Recruiting
GGZ de Viersprong
Halsteren, North Brabant
Joost Hutsebaut, Prof. dr., +31-088-656-216, Klantburo@deviersprong.nl
- Recruiting
GGZ Oost-Brabant
Helmond, North Brabant
Nathan Bachrach, Dr., +31-088-846-04-60, communicatie@ggzoostbrabant.nl
- Not yet recruiting
Altrecht
Zeist, Utrecht
Maarten van Westen, Dr., +31-030-696-5100, altrechtstart@altrecht.nl
About this study
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.'
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:
- 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)?
- What patient characteristics predict which patients will benefit more from specialist or generalist treatment?
Read more
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)
- Conditions
- Severe Personality Disorder
- Being tested
- Schema therapy, Mentalization-based treatment, Guideline-informed treatment for personality disorders
- 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
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schema therapyBehavioural
Also called Schema-focused therapy, SFT
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 treatmentBehavioural
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 disordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Specialist Treatment for Severe Personality Disorders | Active comparator | 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. Receives: Behavioral: Schema therapy; Behavioral: Mentalization-based treatment |
| Generalist Treatment for Severe Personality Disorders | Experimental | 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. Receives: Behavioral: Guideline-informed treatment for personality disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the follow-up assessment 30 months after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start21 Oct 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GGZ de Viersprong, Ggz Oost Brabant, Stichting Altrecht GGZ, Stichting Dimence Group, Tilburg University
- Responsible party
- Sponsor
- Investigators
- Henricus L. Van, Dr., Principal investigator, Arkin NPIJoost Hutsebaut, Prof. dr., Study director, Tilburg University; GGZ de ViersprongNathan Bachrach, Dr., Study chair, Tilburg University; GGZ Oost-Brabant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789380
- Sponsor's protocol ID
- P-DAET NL86263.028.24 / P2409
- Acronym
- P-DAET
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41267049
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.'
- ClinicalTrials.gov ID
- NCT06789380
- Acronym / sponsor ID
- P-DAET / P-DAET NL86263.028.24 / P2409
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- ArkinIndustry (pharma, biotech, devices)
- Collaborators
- GGZ de Viersprong, Ggz Oost Brabant, Stichting Altrecht GGZ, Stichting Dimence Group, Tilburg University
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Specialist Treatment for Severe Personality Disorders | Active comparator | Behavioral: Schema therapy, Behavioral: Mentalization-based treatmentParticipants 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 | Experimental | Behavioral: Guideline-informed treatment for personality disordersParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 'severe' or 'extreme' personality disorder (PD) according to the alternative model for PDs
Key exclusion criteria (3 listed)
- IQ < 75
- legal incapacity
- Any mental state disorder that requires prior treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schema therapyAlso: Schema-focused therapy, SFTSchema 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. | Behavioural | Specialist Treatment for Severe Personality Disorders |
| Mentalization-based treatmentMentalization-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. | Behavioural | Specialist Treatment for Severe Personality Disorders |
| Guideline-informed treatment for personality disordersGIT-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. | Behavioural | Generalist Treatment for Severe Personality Disorders |
Primary outcome
Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
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.
Semi-structured Interview for Personality Functioning (STiP-5.1)
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
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.
8 secondary outcomes
Severity Indices of Personality Problems - Short Form (SIPP-SF)
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Brief Symptom Inventory (BSI)
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Columbia Suicide Severity Rating Scale Screen Version (C-SSRS)
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
SCID-5-PQ
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
EQ-5D-5L
Time frame: 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)
Time frame: 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)
Time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 41267049Bomhof 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.
- Study website aimed at a broad audience.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henricus L. Van, Dr. principal investigator
Arkin NPI
Joost Hutsebaut, Prof. dr. study director
Tilburg University; GGZ de Viersprong
Nathan Bachrach, Dr. study chair
Tilburg University; GGZ Oost-Brabant
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schema therapy, Mentalization-based treatment and Guideline-informed treatment for personality disorders in people with Severe Personality Disorder, run by Arkin at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Philipp Löffler, MSc (+31-020-590-4700, J.P.Loffler@tilburguniversity.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0) (time frame: From enrollment to the follow-up assessment 30 months after the start of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.