Psychotherapeutisch centrum de Viersprong, te Halsteren
Halsteren, Netherlands
NCT Number: NCT06212024
Borderline personality disorder (BPD) is characterized by problems in emotion regulation, identity disturbances, and impaired interpersonal functioning. Because BPD may determine health and quality of life in long term, it is important to focus on early detection and early intervention to prevent worsening. In this study, the effectiveness of a new intervention, MBT-early, is investigated in adolescents with borderline personality problems, using a single-case experimental design (SCED).
V1.0 Initial release - [13/12/2023]: Initial registration.
V1.1 2 Amendments - [14-07-2025]:
* (1) Amendment to to clarify the use of diagnostic data (SCID-5-S) for inclusion purposes and to add logbooks documenting deviations from standard treatment protocols. Approved by the METC on 22-10-2024. * (2) Amendment to include to expand the sample size from 6 to 8 participants and to include a qualitative component involving semi-structured interviews with participants, their caregivers, and therapists. Approved by the METC on 23-01-2025.
This study is active but is not currently recruiting participants.
12 year–18 year
All sexes
Observational
Halsteren, Netherlands
Borderline personality disorder (BPD) is characterized by problems in emotion regulation, identity disturbances, and impaired interpersonal functioning. Because BPD may determine health and quality of life in long term, it is important to focus on early detection and early intervention to prevent worsening. In this study, the effectiveness of a new intervention, MBT-early, is investigated in adolescents with borderline personality problems through a single case experimental design (SCED). Existing studies into the efficacy of psychotherapeutic interventions for young people with a (subclinical) borderline personality disorder (BPD) show mixed results. An obvious explanation therefore lies in the heterogeneity of the samples studied, where the same intervention is investigated by young people with some characteristics of borderline personality problems in an early stage as by young people with significant borderline personality problems at a later stage. However, there is evidence that interventions should be targeted specifically at the stage of progression of the disorder ('staged care'). Interventions may be more effective when they correspond to the stage of disease progression. MBT-early is an intervention intended for young people in an early stage of BPD. The intervention not only addresses the characteristics of BPD, but generally aims to improve personality functioning. MBT-early focuses on strengthening the young person's mentalizing capacity and to increase epistemic trust (the openness to learn from others) in order to prevent developmental stagnation and chronic consequences of personality disfunctioning. Although there is evidence for the efficacy of MBT for adults and adolescents, MBT-early has not yet been studied in terms of effectiveness. This study sets out to investigate the effectiveness of MBT-early, using a Single Case Experimental Design. The investigators hypothesize that treating youngsters with early features of BPD with MBT-early results in reduction of features of personality problems and the most frequently occurring symptoms (depressive symptoms). Exploratively mechanisms of change are being explored.
Research questions:
Objective of the study: The primary objective is to study the effectiveness of MBT-early in terms of treatment outcome on personality functioning and depressive symptoms. As a second objective the investigators will exploratively study the presumed working mechanisms of the MBT-early intervention (mentalizing capacities and epistemic trust).
Amendment 1 (Approved October 22, 2024):
Diagnostic information obtained during intake, using the Structured Clinical Interview for DSM-5 Syndrome Disorders (SCID-5-S), is used to verify inclusion criteria. Although this was part of the original protocol, it has now been explicitly clarified in the participant information material. Additionally, therapist-maintained logbooks documenting deviations from standard treatment protocols (e.g., missed sessions or clinical incidents) have been introduced to enhance contextual interpretation of the SCED data.
Amendment 2 (Approved January 23, 2025):
To increase the representativeness of the sample, the maximum number of participants has been increased from 6 to 8. Furthermore, a qualitative component was added to the design. After completing treatment, participants, their caregivers, and their therapists will be invited to take part in semi-structured interviews to explore perceived treatment processes and outcomes. These interviews aim to enrich interpretation of quantitative findings and explore perspectives on symptom change, treatment satisfaction, and contextual factors.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MBT-early is an early intervention program for young people at risk for developing BPD that has been developed as an adaptation of MBT, an empirically supported treatment for BPD. MBT-early is a time-limited intervention that has been designed for early-stage BPD and focuses on improving personality functioning. MBT-early is a two-phase treatment that integrates interventions at the individual, family, and context level. MBT-early provides a combination of treatment modalities, including individual and family sessions, case management, and treatment reviews. Interventions are tailored to the specific needs of the young person and his/her family. The treatment consists of 16 weekly individual sessions, 3 family sessions, and case management. The initial treatment phase (16 weeks) is followed by a booster period (6 months) with 4 booster sessions. Since MBT-early involves a flexible approach, this standard package may be downscaled in cases of rapid improvement, or upscaled when needed.
Time frame: through study completion, approximately 1 year
Assessed by the Level of Personality Functioning Scale-Brief form, version 2.0 (LPFS-BF-2.0, 12 items). Weekly assessment during the baseline period of six weeks, weekly assessment during the intervention period of 16 weeks and 4 assessments spread over a period of six months, during the booster phase.
Time frame: through study completion, approximately 1 year
Assessed by the Patient Health Questionnaire-2 (PHQ-2, 2 items). Weekly assessment during the baseline period of six weeks, weekly assessment during the intervention period of 16 weeks and 4 assessments spread over a period of six months, during the booster phase.
Time frame: through study completion, approximately 1 year
Assessed by the Reflective Function Questionnaire for Youth-5 (RFQY-5). Weekly assessment during the baseline period of six weeks, weekly assessment during the intervention period of 16 weeks and 4 assessments spread over a period of six months, during the booster phase.
Time frame: through study completion, approximately 1 year
Assessed by 4 selected items from the Questionnaire Epistemic Trust (QET). Weekly assessment during the baseline period of six weeks, weekly assessment during the intervention period of 16 weeks and 4 assessments spread over a period of six months, during the booster phase.
Time frame: Within 60 days after completion of Phase C (final intervention session)
Qualitative data from semi-structured interviews with participants, caregivers, and therapists about perceived treatment effects, explanatory factors, and general experiences with MBT-early.
Semi-structured qualitative interviews with adolescent participants, their caregivers, and their therapists will be conducted within a maximum of 60 days following the final intervention session (completion of Phase C). Interviews will be scheduled as soon as feasible after treatment completion, depending on participant availability, but will not exceed the 60-day time frame
De Viersprong
Other
The Effectiveness of Mentalization-Based Treatment-Early (MBT-early) in Adolescents With Emerging Borderline-personality Disorder: a Single Case Experimental Design
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