Borderline Personality DisorderPhase 3MBT-RCTNCT03677037
The Short-Term MBT Project
A Phase 3 study testing Short-term MBT and Long-term MBT in people with Borderline Personality Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The study will evaluate the benefitial and harmful effects of short-term (20 weeks) compared to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Short-term MBT and Long-term MBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Sep 2018to 15 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Personality disorder(s) considered to be primary diagnosis/diagnoses
- A minimum of four DSM-5 criteria for borderline personality disorder
- Written informed consent
Who cannot join
- Possibility of a learning disability (IQ<75)
- A diagnosis of schizotypal personality disorder or antisocial personality disorder
- Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere
- Current (past 2 months) substance dependance including alcohol
- Concurrent psychotherapeutic treatment outside the clinic
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark
Gentofte Municipality, 2820
About this study
Official title: Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial
The study will evaluate the benefitial and harmful effects of short-term (20 weeks) compared to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder.
Read the detailed description
Psychotherapy for borderline personality disorder is often lengthy and resource-intensive. Mentalization-based therapy is an example of an evidence-based treatment that currently has empirical support as an 18-months outpatient program for borderline personality disorder. However, this duration is rarely available, and the long and costly treatment combined with a highly prevalent disorder result in insufficient access to evidence-based care.
The trial is an investigator-initiated, single-centre, assessor-blinded, randomized clinical superiority trial of short-term (20 weeks) compared to long-term (14 months) outpatient mentalization-based therapy for borderline personality disorder or subthreshold borderline personality disorder. Participants will be recruited from the Outpatient Clinic for Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark. Participants will be assessed at trial intake using the Mini International Neuropsychiatric Interview and the Structured Clinical Interview for DSM-5 Personality Disorders. Participants will be included if they meet a minimum of four DSM-5 criteria for borderline personality disorder. Participants will be assessed blind to treatment allocation at baseline, and at 8, 16, and 24 months after randomization.
The primary outcome is severity of borderline symptomatology assessed using the Zanarini Rating Scale for Borderline Personality Disorder interview. Secondary outcomes include self-harm incidents, functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey), and global functioning (Global Assessment of Functioning scale). Psychiatric symptoms (Symptom Checklist 90) will be included as an exploratory outcome. Measures of personality functioning, attachment, group alliance, borderline symptoms and mentalization skills will be included as predictor and mediator variables.
- Conditions
- Borderline Personality Disorder
- Being tested
- Short-term MBT, Long-term MBT
- Keywords
- mentalization-based therapy, borderline personality disorder, randomized clinical trial, psychotherapy research, treatment intensity
- 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.
Short-term MBTOther
Short-term mentalization-based therapy
Long-term MBTOther
Long-term mentalization-based therapy
| Study group | Role | What they receive |
|---|---|---|
| Short-term MBT | Experimental | The experimental group is short-term mentalization-based therapy. The treatment program includes 20 weeks of mentalization-based group therapy with conjoined individual therapy every second week. The program also includes psychoeducation and individual caseformulations. Receives: Other: Short-term MBT |
| Long-term MBT | Active comparator | The control group is long-term mentalization-based therapy. The treatment program includes 14 months of weekly mentalization-based group therapy with combined individual therapy every second week. The program also includes psychoeducation and individual caseformulations. Receives: Other: Long-term MBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview
ZAN-BPD is an investigator-administered interview assessing change in severity of borderline personality disorder over time. Each of the nine DSM-5 criteria for borderline personality disorder are rated on a scale from 0-4, where 4 is the most severe, yielding a total score from 0-36.
Measured: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Secondary outcomes (4)
Change in functional impairmment assessed with the Work and Social Adjustment Scale (WSAS)
WSAS is a 5-item questionnaire assessing change in functional impairment. Each item is rated on a scale from 0-8, where 0 is no impairment and 8 is severe impairment, yielding a total score between 0-40.
Measured: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Change in quality of life assessed with the Short-Form Health Survey 36 (SF-36)
SF-36 is a questionnaire assessing change in self-reported quality of life over time. The instrument measures eight health dimensions: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score).
Measured: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Change in global functioning assessed with the Global Assessment of Functioning (GAF)
GAF is an investigator-administered rating of change in global functioning over time. Global funtioning is rated on a scale from 0-100 for both symptomatic and functional impairment, yielding two total scores from 0-100, where 100 is no impaitment and 0 is severe impairment.
Measured: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Change in amount of self-harm incidents
Proportion of participants with severe self-harm defined as deliberate acts of self-harm resulting in visible tissue damage - data will be collected as both dichotomous data and count data.
Measured: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start24 Sep 2018
- Primary completion15 Dec 2022
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor
- Investigators
- Sebastian Simonsen, PhD, Study director, Sponsor-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677037
- Sponsor's protocol ID
- H-18023136
- Acronym
- MBT-RCT
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2018
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harpoth TSD, Juul S, Olsen MH, Hestbaek E, Kamp CB, Rishede M, Frandsen FW, Bo S, Poulsen S, Sorensen P, Bateman A, Jakobsen JC, Simonsen S. Effects of Short-Term Versus Long-Term Mentalization-Based Therapy on Psychiatric Symptoms in Outpatients With Borderline Personality Disorder: Exploratory Results From a Randomized Clinical Trial. Personal Ment Health. 2026 Aug;20(3):e70088. doi: 10.1002/pmh.70088.
PubMed 42363615Juul S, Jakobsen JC, Hestbaek E, Jorgensen CK, Olsen MH, Rishede M, Frandsen FW, Bo S, Lunn S, Poulsen S, Sorensen P, Bateman A, Simonsen S. Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT). Psychother Psychosom. 2023;92(5):329-339. doi: 10.1159/000534289. Epub 2023 Nov 7.
PubMed 37935133Juul S, Simonsen S, Poulsen S, Lunn S, Sorensen P, Bateman A, Jakobsen JC. Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT). Trials. 2021 Jul 28;22(1):497. doi: 10.1186/s13063-021-05450-y.
PubMed 34321051Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
PubMed 32880104Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793Juul S, Lunn S, Poulsen S, Sorensen P, Salimi M, Jakobsen JC, Bateman A, Simonsen S. Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial. Trials. 2019 Apr 5;20(1):196. doi: 10.1186/s13063-019-3306-7.
PubMed 30953536
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03677037
- Acronym / sponsor ID
- MBT-RCT / H-18023136
- Conditions
- Borderline Personality Disorder
- Keywords
- mentalization-based therapy, borderline personality disorder, randomized clinical trial, psychotherapy research, treatment intensity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 19 Sep 2018 (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.
The study will evaluate the benefitial and harmful effects of short-term (20 weeks) compared to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder.
Detailed description
Psychotherapy for borderline personality disorder is often lengthy and resource-intensive. Mentalization-based therapy is an example of an evidence-based treatment that currently has empirical support as an 18-months outpatient program for borderline personality disorder. However, this duration is rarely available, and the long and costly treatment combined with a highly prevalent disorder result in insufficient access to evidence-based care.
The trial is an investigator-initiated, single-centre, assessor-blinded, randomized clinical superiority trial of short-term (20 weeks) compared to long-term (14 months) outpatient mentalization-based therapy for borderline personality disorder or subthreshold borderline personality disorder. Participants will be recruited from the Outpatient Clinic for Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark. Participants will be assessed at trial intake using the Mini International Neuropsychiatric Interview and the Structured Clinical Interview for DSM-5 Personality Disorders. Participants will be included if they meet a minimum of four DSM-5 criteria for borderline personality disorder. Participants will be assessed blind to treatment allocation at baseline, and at 8, 16, and 24 months after randomization.
The primary outcome is severity of borderline symptomatology assessed using the Zanarini Rating Scale for Borderline Personality Disorder interview. Secondary outcomes include self-harm incidents, functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey), and global functioning (Global Assessment of Functioning scale). Psychiatric symptoms (Symptom Checklist 90) will be included as an exploratory outcome. Measures of personality functioning, attachment, group alliance, borderline symptoms and mentalization skills will be included as predictor and mediator variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term MBT | Experimental | Other: Short-term MBTThe experimental group is short-term mentalization-based therapy. The treatment program includes 20 weeks of mentalization-based group therapy with conjoined individual therapy every second week. The program also includes psychoeducation and individual caseformulations. |
| Long-term MBT | Active comparator | Other: Long-term MBTThe control group is long-term mentalization-based therapy. The treatment program includes 14 months of weekly mentalization-based group therapy with combined individual therapy every second week. The program also includes psychoeducation and individual caseformulations. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Personality disorder(s) considered to be primary diagnosis/diagnoses
- A minimum of four DSM-5 criteria for borderline personality disorder
- Written informed consent
Key exclusion criteria (6 listed)
- Possibility of a learning disability (IQ<75)
- A diagnosis of schizotypal personality disorder or antisocial personality disorder
- Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere
- Current (past 2 months) substance dependance including alcohol
- Concurrent psychotherapeutic treatment outside the clinic
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 |
|---|---|---|
| Short-term MBTShort-term mentalization-based therapy | Other | Short-term MBT |
| Long-term MBTLong-term mentalization-based therapy | Other | Long-term MBT |
Primary outcome
Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
ZAN-BPD is an investigator-administered interview assessing change in severity of borderline personality disorder over time. Each of the nine DSM-5 criteria for borderline personality disorder are rated on a scale from 0-4, where 4 is the most severe, yielding a total score from 0-36.
4 secondary outcomes
Change in functional impairmment assessed with the Work and Social Adjustment Scale (WSAS)
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Change in quality of life assessed with the Short-Form Health Survey 36 (SF-36)
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Change in global functioning assessed with the Global Assessment of Functioning (GAF)
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Change in amount of self-harm incidents
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Derived from this study: PubMed 42363615Harpoth TSD, Juul S, Olsen MH, Hestbaek E, Kamp CB, Rishede M, Frandsen FW, Bo S, Poulsen S, Sorensen P, Bateman A, Jakobsen JC, Simonsen S. Effects of Short-Term Versus Long-Term Mentalization-Based Therapy on Psychiatric Symptoms in Outpatients With Borderline Personality Disorder: Exploratory Results From a Randomized Clinical Trial. Personal Ment Health. 2026 Aug;20(3):e70088. doi: 10.1002/pmh.70088.
- Derived from this study: PubMed 37935133Juul S, Jakobsen JC, Hestbaek E, Jorgensen CK, Olsen MH, Rishede M, Frandsen FW, Bo S, Lunn S, Poulsen S, Sorensen P, Bateman A, Simonsen S. Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT). Psychother Psychosom. 2023;92(5):329-339. doi: 10.1159/000534289. Epub 2023 Nov 7.
- Derived from this study: PubMed 34321051Juul S, Simonsen S, Poulsen S, Lunn S, Sorensen P, Bateman A, Jakobsen JC. Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT). Trials. 2021 Jul 28;22(1):497. doi: 10.1186/s13063-021-05450-y.
- Derived from this study: PubMed 32880104Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Derived from this study: PubMed 30953536Juul S, Lunn S, Poulsen S, Sorensen P, Salimi M, Jakobsen JC, Bateman A, Simonsen S. Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial. Trials. 2019 Apr 5;20(1):196. doi: 10.1186/s13063-019-3306-7.
- Individual participant dataSharing planned: Undecided
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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.
Sebastian Simonsen, PhD study director
Sponsor-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short-term MBT and Long-term MBT in people with Borderline Personality Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jan 2024. 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03677037, which also lists 6 linked publications.
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 12 Jan 2024.