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Not yet recruiting NCT07509216

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

Observational Borderline Personality Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Borderline Personality Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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. 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.

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. 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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Change in general symptom severity [Time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison]
  • Change in interpersonal problems [Time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison]
  • Change in quality of life [Time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison]
  • Change in reflective functioning [Time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison]
  • Change in personality functioning (self-reported) [Time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison]
  • Level of personality functioning [Time frame: Long-term follow-up only (10-14 years after treatment start)]
  • Sense of belonging [Time frame: Long-term follow-up only (10-14 years after treatment start)]
  • Life satisfaction [Time frame: Long-term follow-up only (10-14 years after treatment start)]
  • Psychosocial functioning [Time frame: Long-term follow-up only (10-14 years after treatment start)]
  • Changes in BPD diagnosis [Time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison.]
  • Changes in health service utilization and productivity losses [Time frame: Assessed at long-term follow-up (10-14 years after treatment start), using prior (baseline) data for comparison]
  • Patient-reported experiences and perceived impact of MBT [Time frame: Long-term follow-up (10-14 years after treatment start)]

Eligibility criteria

Inclusion criteria

  • 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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 2 centers
  • Arkin - NPI — Amsterdam
  • De Viersprong — Halsteren

Identifiers

NCT: NCT07509216 · MEC-2025-0319

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗