NCT07509216

Brief 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). 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:

  • 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 2, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

March 27, 2026

Last Update Submit

April 3, 2026

Conditions

Keywords

mentalisation-based treatmenthealth care utilizationlong-term follow-upborderline personality disorderpsychosocial functioningrecoverypatient-reported outcomespatient experiencesmixed-methodsqualitative researchhealth care costs

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (12)

  • Change in general symptom severity

    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

    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

    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

    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)

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

  • +7 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arkin - NPI

Amsterdam, 1093MB, Netherlands

Location

De Viersprong

Halsteren, 4660AA, Netherlands

Location

MeSH Terms

Conditions

Borderline Personality DisorderPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Dine J. Feenstra, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 3, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations