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| Name | Class |
|---|---|
| Arkin | INDUSTRY |
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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:
Participants will:
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at long-term follow-up (10-14 years after treatment start), using prior 3-year follow-up data for comparison |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
(No separate exclusion criteria are specified, as exclusion follows directly from these inclusion criteria.)
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maaike L. Smits, Dr. | Contact | 0031 88 7656200 | maaike.smits@deviersprong.nl | |
| Dine J. Feenstra, Dr. | Contact | dineke.feenstra@deviersprong.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkin - NPI | Amsterdam | 1093MB | Netherlands |
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.
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| 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| De Viersprong | Halsteren | 4660AA | Netherlands |
|
| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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