Borderline Personality DisorderNCT06212024
MBT-early: a Single Case Experimental Design
An observational study of Borderline Personality Disorder, run by De Viersprong at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Mentalization Based Treatment-early
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Mar 2024to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Psychotherapeutisch centrum de Viersprong, te Halsteren
Halsteren
About this study
Official title: The Effectiveness of Mentalization-Based Treatment-Early (MBT-early) in Adolescents With Emerging Borderline-personality Disorder: 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.
Read more
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.
Read the detailed description
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:
- What is the effectiveness of MBT-early in youth with early stage BPD? 1a) What effect does MBT-early have on the improvement of personality functioning? 1b) What effect does early MBT have on the degree of depressed mood?
- What are the possible working mechanisms of MBT-early? 2a) Does the youth's mentalizing ability influence the improvement of personality functioning? 2b) Does epistemic trust affect the improvement of personality functioning?
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Mentalization Based Treatment-early
- Keywords
- Borderline personality disorder, Early intervention, Single case experimental design, Treatment outcome
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization Based Treatment-earlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBT-early | See intervention description. Within subject comparison. Receives: Behavioral: Mentalization Based Treatment-early |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, approximately 1 year
Secondary outcomes (2)
Mentalizing Capacities
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.
Measured: through study completion, approximately 1 year
Epistemic Trust
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.
Measured: through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start27 Mar 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- De Viersprong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maaike L. Smits, PhD, Principal investigator, Psychotherapeutisch centrum de Viersprong, te Halsteren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212024
- Sponsor's protocol ID
- NL85140.028.23
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2023
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mentalization-Based Treatment-Early (MBT-early) in Adolescents With Emerging Borderline-personality Disorder: a Single Case Experimental Design
- ClinicalTrials.gov ID
- NCT06212024
- Acronym / sponsor ID
- NL85140.028.23
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline personality disorder, Early intervention, Single case experimental design, Treatment outcome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- De ViersprongUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- What is the effectiveness of MBT-early in youth with early stage BPD? 1a) What effect does MBT-early have on the improvement of personality functioning? 1b) What effect does early MBT have on the degree of depressed mood?
- What are the possible working mechanisms of MBT-early? 2a) Does the youth's mentalizing ability influence the improvement of personality functioning? 2b) Does epistemic trust affect the improvement of personality functioning?
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBT-early | – | Behavioral: Mentalization Based Treatment-earlySee intervention description. Within subject comparison. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization Based Treatment-earlyMBT-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. | Behavioural | MBT-early |
Primary outcome
Level of Personality Functioning
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.
Depressive symptoms
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.
2 secondary outcomes
Mentalizing Capacities
Time frame: through study completion, approximately 1 year
Epistemic Trust
Time frame: through study completion, approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maaike L. Smits, PhD principal investigator
Psychotherapeutisch centrum de Viersprong, te Halsteren
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder, run by De Viersprong at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Personality Functioning (time frame: through study completion, approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.