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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stardard Mentalization-Based Treatment | Active Comparator |
| |
| Trauma-Focused Mentalization-Based Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Mentalization-Based Treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Proportion of recruited eligible patients | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Non-eligibility rate | proportion of eligible patients not included | Through study completion, an average of 3 years |
| Proportion of included but untreated patients | Screening failures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Rüfenacht, MD | Contact | +41223054552 | EvaNina.Rufenacht@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva | Geneva | Canton of Geneva | 1205 | Switzerland |
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This study is a monocentric, two-arm feasibility randomised controlled trial (RCT), comparing the intervention (MBT-TF) with TAU (standard MBT).
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| Trauma-Focused Mentalization-Based Treatment | Other | 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). |
|
| 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 | Baseline and 15 months post-randomisation |
| Proportion of patients initiating MBT-TF within three months of recruitment | Through study completion, an average of 3 years |
| Number of days between randomisation and first MBT-TF session | Randomization and First Treatment Day |
| Proportion of missing or incomplete questionnaire responses assessing psychological and social aspects | Through study completion, an average of 3 years |
| Proportion of losses to follow-up | Through study completion, an average of 3 years |
| Treatment completion rate | Rate of patients completing 8 months of treatment | Through study completion, an average of 3 years |
| Mean number of sessions attended | 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. | 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. | 15 months post-randomization |
| Frequency of serious adverse events | 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. | 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. | 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 | At baseline and at 15 months post-randomisation |
| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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