An interventional study of Standard Mentalization-Based Treatment and Trauma-Focused Mentalization-Based Treatment in Borderline Personality Disorder (BPD) and PTSD - Post Traumatic Stress Disorder, sponsored by Eva Rüfenacht. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Eva Rüfenacht · Not applicable, Interventional, and Other
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.
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.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →This is the only study on the registry with Eva Rüfenacht as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Standard Mentalization-Based Treatment
Other: Trauma-Focused Mentalization-Based Treatment
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.
Also known as: TAU (Treatment As Usual), Standard MBT
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).
Recruitment rate
Proportion of recruited eligible patients
Time frame: Through study completion, an average of 3 years
Non-eligibility rate
proportion of eligible patients not included
Time frame: Through study completion, an average of 3 years
Proportion of included but untreated patients
Screening failures
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
Rate of patients completing 8 months of treatment
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
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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
Time frame: At baseline and at 15 months post-randomisation
Start is estimated for Jun 2026; primary completion for Sep 2030, 51 months later.
Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's planned 51 months is above that.
Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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