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MBT-early: a Single Case Experimental Design

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record status
This record was last updated July 15, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Jul 2025 to Jul 2026v4 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 6 to confirmed 8
    • Study description expanded, about 572 words
    • Site details revised
  2. Primary completion date: Jul 2024 to Jul 2025v3
  3. Phase: Not applicable to Not specified
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2024 to Mar 27, 2024
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06212024
Lead Sponsor De Viersprong
Conditions
(from sponsor)		 Borderline Personality Disorder
Related terms Borderline Personality Disorder
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov