MBT-early: a Single Case Experimental Design

NCT06212024 | Active Not Recruiting

• 1 other identifier: NL85140.028.23
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Borderline Personality Disorder

Keywords

Borderline personality disorder; Early intervention; Single case experimental design; Treatment outcome

Outcome Measures

Primary Outcomes (2)

• Level of Personality Functioning

  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.

  through study completion, approximately 1 year

• Depressive symptoms

  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.

  through study completion, approximately 1 year

Secondary Outcomes (2)

• Mentalizing Capacities

  through study completion, approximately 1 year

• Epistemic Trust

  through study completion, approximately 1 year

Other Outcomes (1)

• Semi-structured interviews

  Within 60 days after completion of Phase C (final intervention session)

Study Arms (1)

MBT-early

See intervention description. Within subject comparison.

Behavioral: Mentalization Based Treatment-early

Interventions

Mentalization Based Treatment-early BEHAVIORAL

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.

MBT-early

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target population of this study consists of adolescents referred to de Viersprong, with early-stage BPD, that are indicated for MBT-early by means of regular intake procedure. All adolescents referred to MBT-early are eligible for participation in the study, as there are no additional inclusion criteria for the study, aside from the clinical inclusions and exclusion criteria for the MBT-Early intervention

You may qualify if:

• age between 12 and 18 years,
• Three to six traits of borderline personality disorder as assessed by the Structured Clinical Interview for DSM-5 Syndrome Disorders
• Mild to moderate disability with regard to functioning in school, at home and in the peer group.

You may not qualify if:

• presence of a primary diagnosis that requires other specialist treatment (e.g. autism spectrum disorder, chronic psychotic disorder, severe eating disorder of sever substance abuse disorder),
• More than one comorbid classification,
• IQ \< 75,
• Severe disability with regard to functioning in school, at home and in the peer group representative for later stage BPD.

Sponsors & Collaborators

• De Viersprong: lead

Study Sites (1)

Psychotherapeutisch centrum de Viersprong, te Halsteren

Halsteren, Netherlands

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Maaike L. Smits, PhD

  Psychotherapeutisch centrum de Viersprong, te Halsteren

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 18, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)