MBT-early: a Single Case Experimental Design

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.

NCT Number	NCT06212024
Lead Sponsor	De Viersprong
Conditions	Borderline Personality Disorder
Enrollment	8 participants
Start Date	2024-03-27
Primary Completion	2026-07 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2025-07-15