Pilot Study for the Evaluation of a New Psychotherapeutic Treatment for Borderline Personality Disorder Patients With Post-traumatic Stress Symptoms
NCT ID: NCT07305155
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-01-01
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Stardard Mentalization-Based Treatment
Standard 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.
Trauma-Focused Mentalization-Based Treatment
Trauma-Focused Mentalization-Based Treatment
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).
Interventions
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Standard 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.
Trauma-Focused Mentalization-Based Treatment
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Eva Rüfenacht
OTHER
Responsible Party
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Eva Rüfenacht
Senior Physician, Head of the Emotion Regulation Disorders Unit , Principal Investigator
Locations
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University Hospitals of Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Other Identifiers
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2025-01307
Identifier Type: -
Identifier Source: org_study_id