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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Change in borderline symptom severity between 3-year follow-up and long-term follow-up
研究概览
简要总结
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:
- 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?
- 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?
- 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.
详细描述
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.
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •are specified, as exclusion follows directly from these inclusion criteria.)
研究组 & 干预措施
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.
结局指标
主要结局
Change in borderline symptom severity between 3-year follow-up and long-term follow-up
时间窗: 3-year follow-up to long-term follow-up (10-14 years after treatment start)
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.
Change in borderline symptom severity between 3-year follow-up and long-term follow-up
时间窗: 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.
次要结局
- Change in general symptom severity(3-year follow-up to long-term follow-up (10-14 years after treatment start))
- Change in interpersonal problems(3-year follow-up to long-term follow-up (10-14 years after treatment start))
- Change in quality of life(3-year follow-up to long-term follow-up (10-14 years after treatment start))
- Change in reflective functioning(3-year follow-up to long-term follow-up (10-14 years after treatment start))
- Change in personality functioning (self-reported)(3-year follow-up to long-term follow-up (10-14 years after treatment start))
- Level of personality functioning(Long-term follow-up only (10-14 years after treatment start))
- Sense of belonging(Long-term follow-up only (10-14 years after treatment start))
- Life satisfaction(Long-term follow-up only (10-14 years after treatment start))
- Psychosocial functioning(Long-term follow-up only (10-14 years after treatment start))
- Changes in BPD diagnosis(3-year follow-up to long-term follow-up (10-14 years after treatment start))
- Changes in health service utilization and productivity losses(Baseline, 3-year follow-up, and long-term follow-up (10-14 years after treatment start))
- Patient-reported experiences and perceived impact of MBT(Long-term follow-up (10-14 years after treatment start))
- 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)
- Changes in BPD diagnosis(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(Assessed at long-term follow-up (10-14 years after treatment start), using prior (baseline) data for comparison)