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Borderline Personality DisorderMBT-EVOLVENCT07509216

Long Term Follow-up of Mentalization-Based Treatment: Exploring Variability in Outcomes, Long-term Value and Experiences 10+ Year After Receiving MBT Day Hospital or MBT Intensive Outpatient

An observational study of Borderline Personality Disorder, run by De Viersprong at 2 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a long-term follow-up study of a previous multicenter randomized controlled trial, in which n=114 participants were included. This RCT compared the effectiveness of two intensities of mentalisation-based treatment (MBT) for individuals with borderline personality disorder (BPD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Borderline Personality Disorder
How many people
113 participants
Where
2 sitesNetherlands
Study dates
2 Apr 2026to Jun 2027
Phase
Observational
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

Study population: The study population consists of individuals who previously participated in the randomized controlled trial comparing MBT-DH with MBT-IOP for BPD in the Netherlands. Inclusion criteria were: a BPD diagnosis (SCID-II); age 18 years or older; adequate Dutch language skills; travel time to the MBT clinic of less than one hour. Exclusion criteria: autism spectrum disorder, chronic psychotic disorder or organic brain disorder that significantly interfered with mentalizing; intellectual impairment (IQ < 80), or antisocial personality disorder with a history of severe physical violence. For this follow-up, all 113 individuals who did not decline future contact will be approached. No new age or diagnostic limits apply. This is a non-probability sample because it consists of the entire available cohort from the original RCT. Participants will initially be invited consecutively to the qualitative substudy; if response permits, purposive sampling will be used to ensure variation.

Who may be able to join

  • Participation in the original randomized controlled trial of mentalization-based treatment (MBT-DH versus MBT-IOP)
  • Did not decline to be contacted for future research
  • Able to provide informed consent at the time of the long-term follow-up assessment
  • (No separate exclusion criteria are specified, as exclusion follows directly from these inclusion criteria.)

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dine J. Feenstra, Dr. contact

dineke.feenstra@deviersprong.nl

Netherlands2 sites, 2 recruiting
  • Arkin - NPI

    Amsterdam, 1093MB

    Rien Van, Dr., 0031 205905002

    Recruiting
  • De Viersprong

    Halsteren, 4660AA

    Maaike L. Smits, Dr., 0031887656200, maaike.smits@deviersprong.nl

    Janneke Husson, Dr., 003188 7656 200, janneke.husson@deviersprong.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: MBT-EVOLVE: Mentalization-Based Treatment: Exploring Variability in Outcomes, Long-term Value and Experiences: A 10+ Year Follow-up of Two Types of MBT for BPD - Quantitative and Qualitative Perspectives on Long-term Functioning

This study is a long-term follow-up study of a previous multicenter randomized controlled trial, in which n=114 participants were included. This RCT compared the effectiveness of two intensities of mentalisation-based treatment (MBT) for individuals with borderline personality disorder (BPD).

The goal of this study is to learn how people who received MBT in the past for BPD are doing more than 10 years later. MBT is a type of psychotherapy that helps people understand and manage their thoughts and feelings, and supports improvements in identity and relationships, with the aim of improving daily life functioning.

Read more

The main questions this study aims to answer are:

  1. How are people who received MBT in the past functioning more than 10 years later, and how is their use of mental health care and associated costs at this point in their lives?
  2. Do long-term outcomes differ between people who received day-hospital MBT and people who received intensive outpatient MBT, and are these outcomes influenced by how much time has passed since treatment ended or by clinical characteristics from the past, such as symptom severity, trauma history, or level of mentalizing?
  3. How do people who received MBT experience its impact on their symptoms, daily life, and relationships both during treatment and in the years afterward, including the impact of treatment intensity?

Participants will:

  • Fill in online questionnaires about symptoms, relationships, health, and daily functioning (about 60 minutes).
  • Take part in a short interview to check whether BPD symptoms are still present (about 20 minutes).
  • A smaller group will be invited for a longer semi-structured qualitative interview (about 60 minutes) to talk about their personal experiences with MBT and what has impacted their life after treatment.

There are no new treatments in this study. All participants completed MBT many years ago. Participation happens online or in person based on personal preference.

Read the detailed description

This observational study examines long-term outcomes more than 10 years after people received mentalization-based treatment (MBT) for borderline personality disorder (BPD). Although improvements after MBT have been demonstrated up to three years after the start of treatment, little is known about how people function over a much longer period and whether treatment gains translate into sustained improvements in everyday life. This study focuses on broader developmental and psychosocial recovery, including interpersonal functioning, identity development, and participation in society, domains that have typically shown the least responsiveness to treatment compared with improvements in psychopathology or symptoms.

Participants in this study took part in an earlier randomized controlled trial comparing two different MBT programs: a day-hospital program (MBT-DH) and an intensive outpatient program (MBT-IOP). Both programs showed positive effects in the original study up to three years after start of treatment, but the long-term course of functioning and service use after treatment remains unclear. Understanding how people have progressed in the years since treatment, and whether earlier characteristics influence their current functioning, may help refine treatment models and improve accessibility and cost-effectiveness of MBT.

This study has three aims.

  1. First, it examines current functioning, including symptoms, interpersonal relationships, daily life functioning, and mental health care use and costs more than 10 years after the start of treatment. It also investigates whether long-term outcomes are influenced by the time elapsed since the original treatment ended or by clinical characteristics from the past, such as symptom severity, trauma history, or level of mentalizing before treatment.
  2. Second, it explores potential differences in long-term outcomes between people who received MBT-DH and people who received MBT-IOP.
  3. Third, it investigates participants' own perspectives on the impact of MBT, both during treatment and in the years following treatment, including their experiences with treatment intensity.

All participants from the original trial, except the one person who declined to be contacted for future research, will be approached and invited to complete a set of online self-report questionnaires and a short interview to evaluate whether BPD symptoms are still present. A smaller group will also be invited for an in-depth qualitative interview about their experiences with MBT and how treatment may have influenced their lives and functioning.

This mixed-methods follow-up approach will contribute to a better understanding of long-term adaptation after MBT and may inform the design of future treatment pathways for people with BPD.

Keywords
mentalisation-based treatment, health care utilization, long-term follow-up, borderline personality disorder, psychosocial functioning, recovery, patient-reported outcomes, patient experiences, mixed-methods, qualitative research, health care costs
Medical subject headings
Borderline Personality Disorder, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07509216
Study groupRoleWhat they receive
Day-hospital mentalisation-based treatment (MBT-DH)Participants received MBT during the original RCT. MBT is a psychodynamically oriented psychotherapy that targets problems in identity, interpersonal relationships, and emotion regulation by supporting improvements in mentalizing capacity. All participants follow an introductory MBT program (MBT-I), consisting of 12 psycho-educational group sessions. MBT-DH involved a structured day-hospital program covering five days per week, comprising daily group psychotherapy, art therapy twice per week, mentalizing cognitive group therapy, and writing therapy. Patients also received weekly individual psychotherapy and crisis planning as needed. A psychiatrist could be consulted and medication prescribed according to APA guidelines. After the intensive phase, stepped-down care was offered to support relapse prevention, further development of mentalizing capacity, and reintegration into society.
Intensive-outpatient mentalisation-based treatment (MBT-IOP)Participants received MBT during the original RCT. MBT is a psychodynamically oriented psychotherapy that targets problems in identity, interpersonal relationships, and emotion regulation by supporting improvements in mentalizing capacity. All participants follow an introductory MBT program (MBT-I), consisting of 12 psycho-educational group sessions. In MBT-IOP the frequency of group psychotherapy is substantially lower as compared to MBT-DH comprising two group psychotherapy sessions each week, supplemented by weekly individual psychotherapy and crisis planning if required. A psychiatrist could be consulted and medication prescribed according to APA guidelines. After the intensive phase, stepped-down care was offered to support relapse prevention, further development of mentalizing capacity, and reintegration into society.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in borderline symptom severity between 3-year follow-up and long-term follow-up

    Borderline symptom severity is measured using the Personality Assessment Inventory-Borderline Features Scale (PAI-BOR). Scores range from 0 to 72, with higher scores indicating more severe borderline features. The primary estimate of interest is the change in PAI-BOR score from the 3-year follow-up assessment to the long-term follow-up assessment conducted 10-14 years after treatment start. Repeated measures collected between baseline and 3-year follow-up will be incorporated in the analyses to account for prior trajectories.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

Secondary outcomes (12)
  1. Change in general symptom severity

    General symptom severity as measured using the Brief Symptom Inventory (BSI-53). Items are scored on a 0 to 4 scale. The Global Severity Index (GSI) represents overall distress, with higher scores indicating greater severity of symptoms. The primary estimate of interest is the change in GSI score from the 3-year follow-up assessment to the long-term follow-up assessment conducted 10-14 years after treatment start. Repeated measures collected between baseline and 3-year follow-up will be incorporated in the analyses to account for prior trajectories.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

  2. Change in interpersonal problems

    Interpersonal problems are measured with the Inventory of Interpersonal Problems (IIP-64). Items are rated on a 0 to 4 scale, with higher scores indicating more interpersonal problems across eight domains (for example, nonassertive, socially inhibited). The primary estimate of interest is the change in IIP total score from the 3-year follow-up assessment to the long-term follow-up assessment conducted 10-14 years after treatment start. Repeated measures collected between baseline and 3-year follow-up will be incorporated in the analyses to account for prior trajectories.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

  3. Change in quality of life

    Quality of life is measured using the EuroQol-5D-3L (EQ-5D-3L). Each of five dimensions has three response levels. Higher values on the index score reflect better health-related quality of life. The primary estimate of interest is the change in the index score from the 3-year follow-up assessment to the long-term follow-up assessment conducted 10-14 years after treatment start. Repeated measures collected between baseline and 3-year follow-up will be incorporated in the analyses to account for prior trajectories.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

  4. Change in reflective functioning

    Reflective functioning is measured using the Reflective Functioning Questionnaire-8 (RFQ-8). Scores reflect uncertainty or certainty regarding mental states. The Uncertainty subscale has shown most sensitivity to change and evidence on the psychometric qualities concerning the Certainty subscale has shown mixed results, therefore we will focus on the subscale Uncertainty as outcome measure for the domain of reflective functioning. The primary estimate of interest is the change in Uncertainty subscale score from the 3-year follow-up assessment to the long-term follow-up assessment conducted 10-14 years after treatment start. Repeated measures collected between baseline and 3-year follow-up will be incorporated in the analyses to account for prior trajectories.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

  5. Change in personality functioning (self-reported)

    Personality functioning is assessed using the Severity Indices of Personality Problems-Short Form (SIPP-SF). Higher scores indicate better adaptive personality functioning across five core domains. The primary estimate of interest is the change in the five subscale scores from the 3-year follow-up assessment to the long-term follow-up assessment conducted 10-14 years after treatment start. Repeated measures collected between baseline and 3-year follow-up will be incorporated in the analyses to account for prior trajectories.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

  6. Level of personality functioning

    Impairments in personality functioning are assessed using the Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF 2.0). Higher scores reflect greater impairment in self- and interpersonal functioning. No direct comparison will be made with previous assessments, as this measure was not included in the original trial. Scores at long-term follow-up will be interpreted using available normative scores to determine level of functioning.

    Measured: Long-term follow-up only (10-14 years after treatment start)

  7. Sense of belonging

    Sense of belonging is measured by means of the PROMIS Short Form v2.0 Social Isolation. Participants indicate how often they feel left out, that people barely know them, isolated from others, and that people are around them but not with them in the past month on a Likert-type scale from 1 (never) to 5 (always). No direct comparison will be made with previous assessments, as this measure was not included in the original trial. Scores at long-term follow-up will be interpreted using available normative scores to determine level of functioning.

    Measured: Long-term follow-up only (10-14 years after treatment start)

  8. Life satisfaction

    Life satisfaction is assessed by means of the Quality of Life Enjoyment and Satisfaction Questionnaire Short-Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item self-report questionnaire that measures the degree of enjoyment and satisfaction experienced in various domains of daily functioning, including work, social relationships, household activities, economic status and overall wellbeing on a 5 point likert scale ranging from 1 (very poor) to very good (5). No direct comparison will be made with previous assessments, as this measure was not included in the original trial. Scores at long-term follow-up will be interpreted using available normative scores to determine level of functioning.

    Measured: Long-term follow-up only (10-14 years after treatment start)

  9. Psychosocial functioning

    Psychosocial functioning is assessed means of the 12-item WHO Disability Assessment Schedule (WHODAS 2.0). The WHODAS measures disability and functional impairment across six domains: cognition, mobility, self-care, interpersonal relationships, life activities, and participation in society. No direct comparison will be made with previous assessments, as this measure was not included in the original trial. Scores at long-term follow-up will be interpreted using available normative scores to determine level of functioning.

    Measured: Long-term follow-up only (10-14 years after treatment start)

  10. Changes in BPD diagnosis

    BPD diagnosis is assessed using the BPD section of the Dutch version of the SCID-II. Diagnostic status is operationalized as the dimensional score on BPD criteria, the number of criteria met, and the presence or absence of a BPD diagnosis. Current diagnostic status at long-term follow-up (10-14 years post-treatment) will be compared with previously collected data from the 3-year follow-up.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison.

  11. Changes in health service utilization and productivity losses

    Health service use and productivity losses are assessed using the TiC-P questionnaire. Higher estimates reflect greater service utilization and higher direct and indirect costs. Health care utilization during the year prior to the long-term follow-up assessment will be compared to utilization during year prior to the baseline, and the year prior to the 3-year follow-up assessment.

    Measured: Assessed at long-term follow-up (10-14 years after treatment start), using prior (baseline) data for comparison

  12. Patient-reported experiences and perceived impact of MBT

    Participants' experiences of MBT and its impact on symptoms, daily life functioning, and relationships, and views on treatment intensity, assessed through a semi-structured interview at long-term follow-up.

    Measured: Long-term follow-up (10-14 years after treatment start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study start2 Apr 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
113 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07509216
Sponsor's protocol ID
MEC-2025-0319
Acronym
MBT-EVOLVE
Status last verified
Sep 2026
First submitted
27 Mar 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) collected in this long-term follow-up study will not be shared publicly because they contain sensitive clinical and personal information from a small high-risk population and full de-identification cannot be guaranteed. Access to the data is restricted under the data protection and ethical requirements of the original randomized controlled trial and the current follow-up study. Researchers may request access to aggregated outcomes or additional information by contacting the study team, subject to data protection regulations and agreements.

Questions about this trial

What is this clinical trial studying?

An observational study of Borderline Personality Disorder, run by De Viersprong at 2 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 4 inclusion and 0 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Maaike L. Smits, Dr. (0031 88 7656200, maaike.smits@deviersprong.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in borderline symptom severity between 3-year follow-up and long-term follow-up (time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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