Borderline Personality Disorder (BPD)MBT-TFNCT07305155
Pilot Study for the Evaluation of a New Psychotherapeutic Treatment for Borderline Personality Disorder Patients With Post-traumatic Stress Symptoms
A study testing Standard Mentalization-Based Treatment and Trauma-Focused Mentalization-Based Treatment in people with Borderline Personality Disorder (BPD) and PTSD - Post Traumatic Stress Disorder, run by Eva Rüfenacht at 1 site in Switzerland.
Trial summary
Borderline Personality Disorder (BPD) is a serious mental health condition that often co-occurs with Complex PTSD (CPTSD), making treatment more challenging. Trauma-Focused Mentalization-Based Treatment (MBT-TF) is a new adaptation of standard MBT designed for individuals with high trauma exposure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder (BPD), PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Standard Mentalization-Based Treatment and Trauma-Focused Mentalization-Based Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2026to Dec 2030
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Meeting ≥4 of 9 SCID-5 PD criteria associated with functional impairment (either subthreshold or full BPD diagnosis), and an LPFS-BF 2.0 score ≥31 (≥1.5 standard deviations above the latent mean, T-score ≥65), indicating moderate to severe personality disorder features.
- Diagnosis of CPTSD according to ICD-11 criteria, confirmed via ITQ with clinical checks.
Who cannot join
- Mental disability.
- Severe psychiatric psychopathology requiring immediate treatment (e.g., BMI <16.5, acute bipolar episode, current psychosis).
- Severe active substance dependence.
- Severe physical health problems (e.g., severe cardiovascular conditions). Severe neurological disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospitals of Geneva
Geneva, Canton of Geneva, 1205
About this study
Official title: A Feasibility Randomized-controlled Trial Comparing Trauma-focused Mentalization Based Treatment With Standard Mentalization-based Treatment in Patients Presenting With Complex Post-traumatic Stress and Borderline Personality Disorder
Borderline Personality Disorder (BPD) is a serious mental health condition that often co-occurs with Complex PTSD (CPTSD), making treatment more challenging. Trauma-Focused Mentalization-Based Treatment (MBT-TF) is a new adaptation of standard MBT designed for individuals with high trauma exposure. Early findings are promising, but further research is needed. This study at Geneva University Hospitals (HUG) will test the feasibility and acceptability of MBT-TF compared with standard MBT, gathering feedback from patients and clinicians and laying the groundwork for a larger clinical trial.
Read the detailed description
Borderline Personality Disorder (BPD) is a serious mental health condition that can make it difficult for people to regulate emotions and maintain relationships. Even with specialised therapy, many individuals with BPD continue to experience significant difficulties in daily life.
A large proportion of patients with BPD also show symptoms of trauma, such as Post-Traumatic Stress Disorder (PTSD) or its more complex form (CPTSD). About half of all patients with BPD meet the criteria for CPTSD, and this overlap may partly explain why standard treatments are sometimes less effective. At present, there are no clear treatment guidelines for people who have both BPD and CPTSD, even though this combination greatly affects quality of life and social functioning.
Mentalization-Based Treatment (MBT) is a structured therapy developed in the 1990s for BPD. A newer version, Trauma-Focused MBT (MBT-TF), has been designed for individuals with high levels of trauma or CPTSD. Early results from MBT-TF are promising, but further research is needed before a large-scale trial can be undertaken.
This upcoming study at Geneva University Hospitals (HUG) will examine whether MBT-TF can be delivered effectively and accepted by both patients and clinicians, compared with standard MBT ("treatment as usual"). It will also gather early evidence on whether MBT-TF may be more effective. An independent steering committee of international experts and a patient representative will oversee the trial.
Patients will be followed during 15 months, including 1 year of treatment. Patients will have to fill in questionnaires, and follow individual interviews. In total, 5 visits will be performed for the study, in addition to the stardard clinical follow-up.
- Being tested
- Standard Mentalization-Based Treatment, Trauma-Focused Mentalization-Based Treatment
- Keywords
- Borderline Personality Disorder, Post Traumatic Stress Disorder, Mentalization-based treatment, trauma-focused mentalization-based treatment
- Medical subject headings
- Borderline Personality Disorder, Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Mentalization-Based TreatmentOther
Also called TAU (Treatment As Usual), Standard MBT
Standard MBT treatment, specialized and validated treatment for BPD, which consists of weekly group and individual sessions for one year without any trauma focus, will serve as a comparison.
Trauma-Focused Mentalization-Based TreatmentOther
The intervention will be a trauma-focused Mentalization-based treatment (MBT-TF), consisting of a 3-phase group intervention with an individual component (weekly sessions) offered as needed, focused psychoeducation about post-traumatic stress symptoms and on improving trauma related mentalizing abilities and interpersonal functioning over a 12-month period (45-50 sessions in total).
| Study group | Role | What they receive |
|---|---|---|
| Stardard Mentalization-Based Treatment | Active comparator | Not described Receives: Other: Standard Mentalization-Based Treatment |
| Trauma-Focused Mentalization-Based Treatment | Experimental | Not described Receives: Other: Trauma-Focused Mentalization-Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of recruited eligible patients
Measured: Through study completion, an average of 3 years
Secondary outcomes (15)
Non-eligibility rate
proportion of eligible patients not included
Measured: Through study completion, an average of 3 years
Proportion of included but untreated patients
Screening failures
Measured: Through study completion, an average of 3 years
Mean pre-treatment and 15-month follow-up differences in CAPS-5 or ITQ CPTSD with clinical checks scores
Measured: Baseline and 15 months post-randomisation
Proportion of patients initiating MBT-TF within three months of recruitment
Measured: Through study completion, an average of 3 years
Number of days between randomisation and first MBT-TF session
Measured: Randomization and First Treatment Day
Proportion of missing or incomplete questionnaire responses assessing psychological and social aspects
Measured: Through study completion, an average of 3 years
Proportion of losses to follow-up
Measured: Through study completion, an average of 3 years
Treatment completion rate
Rate of patients completing 8 months of treatment
Measured: Through study completion, an average of 3 years
Mean number of sessions attended
Measured: Through study completion, an average of 3 years
Patient expectation and credibility score
Patient expectation and credibility assessed with validated scale ("The French credibility/expectancy questionnaire"). This questionnaire has a two-factor structure, and includes six items assessing credibility (3) and expectancy (3), with a higher score indicating higher credibility and/or expectancy.
Measured: At baseline and at 15 months post randomisation
Patient satisfaction score
Patient satisfaction score is assessed with the validated "Client Satisfaction Questionnaire (CSQ-8)"). The questionnaire evaluates client satisfaction based on 8 questions and on a 4-point Lickert scale (1 = unsatisfied, 4 = satisfied). Higher score indicates higher satisfaction.
Measured: 15 months post-randomization
Frequency of serious adverse events
Measured: Baseline, 9 months, 15 months, 18 months post randomisation
Average therapist adherence scores across sessions for both arms using a standardised adherence scale
Therapist fidelity to MBT-TF and standard MBT will be assessed using the French version of the MBT-Adherence and Competence Scale (MBT-ACS) and a complementary MBT-TF-specific rating. The average therapist adherence scores will be assessed across sessions for both arms (0-5, "0 = no adherence", "5 = full adherence") measuring fidelity to key protocol components, including therapeutic techniques, session structure, and mentalizing interventions.
Measured: 15 months post-randomisation
Mean change in CAPS-5 total score
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Rating ranges from 0 (absent) to 4 (extreme/incapacitating) for each of the 20 items. Total symptom severity score is calculated by summing scores for all items.
Measured: At baseline and at 15 months post-randomisation
Mean change in ITQ CPTSD with clinical checks total symptom score
ITQ: International Trauma Questionnaire with clinical checks Scoring based on a 0-4 Likert scale ('Not at all' to 'Extremely') for each item (18 in total), higher scores indicating greater severity
Measured: At baseline and at 15 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a monocentric, two-arm feasibility randomised controlled trial (RCT), comparing the intervention (MBT-TF) with TAU (standard MBT).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eva Rüfenacht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Rüfenacht, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305155
- Sponsor's protocol ID
- 2025-01307
- Other IDs
- 2025
- Acronym
- MBT-TF
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomized-controlled Trial Comparing Trauma-focused Mentalization Based Treatment With Standard Mentalization-based Treatment in Patients Presenting With Complex Post-traumatic Stress and Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT07305155
- Acronym / sponsor ID
- MBT-TF / 2025-01307
- Keywords
- Borderline Personality Disorder, Post Traumatic Stress Disorder, Mentalization-based treatment, trauma-focused mentalization-based treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eva RüfenachtUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Dec 2025 (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 a serious mental health condition that often co-occurs with Complex PTSD (CPTSD), making treatment more challenging. Trauma-Focused Mentalization-Based Treatment (MBT-TF) is a new adaptation of standard MBT designed for individuals with high trauma exposure. Early findings are promising, but further research is needed. This study at Geneva University Hospitals (HUG) will test the feasibility and acceptability of MBT-TF compared with standard MBT, gathering feedback from patients and clinicians and laying the groundwork for a larger clinical trial.
Detailed description
Borderline Personality Disorder (BPD) is a serious mental health condition that can make it difficult for people to regulate emotions and maintain relationships. Even with specialised therapy, many individuals with BPD continue to experience significant difficulties in daily life.
A large proportion of patients with BPD also show symptoms of trauma, such as Post-Traumatic Stress Disorder (PTSD) or its more complex form (CPTSD). About half of all patients with BPD meet the criteria for CPTSD, and this overlap may partly explain why standard treatments are sometimes less effective. At present, there are no clear treatment guidelines for people who have both BPD and CPTSD, even though this combination greatly affects quality of life and social functioning.
Mentalization-Based Treatment (MBT) is a structured therapy developed in the 1990s for BPD. A newer version, Trauma-Focused MBT (MBT-TF), has been designed for individuals with high levels of trauma or CPTSD. Early results from MBT-TF are promising, but further research is needed before a large-scale trial can be undertaken.
This upcoming study at Geneva University Hospitals (HUG) will examine whether MBT-TF can be delivered effectively and accepted by both patients and clinicians, compared with standard MBT ("treatment as usual"). It will also gather early evidence on whether MBT-TF may be more effective. An independent steering committee of international experts and a patient representative will oversee the trial.
Patients will be followed during 15 months, including 1 year of treatment. Patients will have to fill in questionnaires, and follow individual interviews. In total, 5 visits will be performed for the study, in addition to the stardard clinical follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a monocentric, two-arm feasibility randomised controlled trial (RCT), comparing the intervention (MBT-TF) with TAU (standard MBT).
| Arm | Type | Receives |
|---|---|---|
| Stardard Mentalization-Based Treatment | Active comparator | Other: Standard Mentalization-Based Treatment |
| Trauma-Focused Mentalization-Based Treatment | Experimental | Other: Trauma-Focused Mentalization-Based Treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years.
- Meeting ≥4 of 9 SCID-5 PD criteria associated with functional impairment (either subthreshold or full BPD diagnosis), and an LPFS-BF 2.0 score ≥31 (≥1.5 standard deviations above the latent mean, T-score ≥65), indicating moderate to severe personality disorder features.
- Diagnosis of CPTSD according to ICD-11 criteria, confirmed via ITQ with clinical checks.
Key exclusion criteria (4 listed)
- Mental disability.
- Severe psychiatric psychopathology requiring immediate treatment (e.g., BMI <16.5, acute bipolar episode, current psychosis).
- Severe active substance dependence.
- Severe physical health problems (e.g., severe cardiovascular conditions). Severe neurological disorder.
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 |
|---|---|---|
| Standard Mentalization-Based TreatmentAlso: TAU (Treatment As Usual), Standard MBTStandard MBT treatment, specialized and validated treatment for BPD, which consists of weekly group and individual sessions for one year without any trauma focus, will serve as a comparison. | Other | Stardard Mentalization-Based Treatment |
| Trauma-Focused Mentalization-Based TreatmentThe intervention will be a trauma-focused Mentalization-based treatment (MBT-TF), consisting of a 3-phase group intervention with an individual component (weekly sessions) offered as needed, focused psychoeducation about post-traumatic stress symptoms and on improving trauma related mentalizing abilities and interpersonal functioning over a 12-month period (45-50 sessions in total). | Other | Trauma-Focused Mentalization-Based Treatment |
Primary outcome
Recruitment rate
Time frame: Through study completion, an average of 3 years
Proportion of recruited eligible patients
15 secondary outcomes
Non-eligibility rate
Time frame: Through study completion, an average of 3 years
Proportion of included but untreated patients
Time frame: Through study completion, an average of 3 years
Mean pre-treatment and 15-month follow-up differences in CAPS-5 or ITQ CPTSD with clinical checks scores
Time frame: Baseline and 15 months post-randomisation
Proportion of patients initiating MBT-TF within three months of recruitment
Time frame: Through study completion, an average of 3 years
Number of days between randomisation and first MBT-TF session
Time frame: Randomization and First Treatment Day
Proportion of missing or incomplete questionnaire responses assessing psychological and social aspects
Time frame: Through study completion, an average of 3 years
Proportion of losses to follow-up
Time frame: Through study completion, an average of 3 years
Treatment completion rate
Time frame: Through study completion, an average of 3 years
Mean number of sessions attended
Time frame: Through study completion, an average of 3 years
Patient expectation and credibility score
Time frame: At baseline and at 15 months post randomisation
Patient satisfaction score
Time frame: 15 months post-randomization
Frequency of serious adverse events
Time frame: Baseline, 9 months, 15 months, 18 months post randomisation
Average therapist adherence scores across sessions for both arms using a standardised adherence scale
Time frame: 15 months post-randomisation
Mean change in CAPS-5 total score
Time frame: At baseline and at 15 months post-randomisation
Mean change in ITQ CPTSD with clinical checks total symptom score
Time frame: At baseline and at 15 months post-randomisation
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 6 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Mentalization-Based Treatment and Trauma-Focused Mentalization-Based Treatment in people with Borderline Personality Disorder (BPD) and PTSD - Post Traumatic Stress Disorder, run by Eva Rüfenacht at 1 site in Switzerland.
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: opening soon, as of the sponsor's last update on 6 Feb 2026. 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 Switzerland. 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?
Contact Eva Rüfenacht, MD (+41223054552, EvaNina.Rufenacht@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion, an average of 3 years). 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 6 Feb 2026.