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Follow-up a lungo termine del trattamento basato sulla mentalizzazione: esplorazione della variabilità degli esiti, del valore a lungo termine e delle esperienze oltre 10 anni dopo aver ricevuto MBT Day Hospital o MBT Intensive Outpatient (MBT-EVOLVE)

25 settembre 2026 aggiornato da: De Viersprong

MBT-EVOLVE: Trattamento Basato sulla Mentalizzazione: Esplorazione della Variabilità nei Risultati, Valore a Lungo Termine ed Esperienze: Un Follow-up di 10+ Anni di Due Tipi di MBT per il Disturbo Borderline di Personalità - Prospettive Quantitative e Qualitative sul Funzionamento a Lungo Termine

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.

Panoramica dello studio

Stato

Reclutamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

113

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Amsterdam, Olanda, 1093MB
        • Reclutamento
        • Arkin - NPI
        • Contatto:
          • Rien Van, Dr.
          • Numero di telefono: 0031 205905002
      • Halsteren, Olanda, 4660AA

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in borderline symptom severity between 3-year follow-up and long-term follow-up
Lasso di tempo: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

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.

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in general symptom severity
Lasso di tempo: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison

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.

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

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.

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

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.

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

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.

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

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.

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
Lasso di tempo: Long-term follow-up only (10-14 years after treatment start)

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.

Long-term follow-up only (10-14 years after treatment start)
Sense of belonging
Lasso di tempo: Long-term follow-up only (10-14 years after treatment start)

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.

Long-term follow-up only (10-14 years after treatment start)
Life satisfaction
Lasso di tempo: Long-term follow-up only (10-14 years after treatment start)

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.

Long-term follow-up only (10-14 years after treatment start)
Psychosocial functioning
Lasso di tempo: Long-term follow-up only (10-14 years after treatment start)

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.

Long-term follow-up only (10-14 years after treatment start)
Changes in BPD diagnosis
Lasso di tempo: Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison.

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.

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

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.

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
Lasso di tempo: Long-term follow-up (10-14 years after treatment start)

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.

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 aprile 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

27 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 marzo 2026

Primo Inserito (Effettivo)

3 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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