Pilot Study for the Evaluation of a New Psychotherapeutic Treatment for Borderline Personality Disorder Patients With Post-traumatic Stress Symptoms

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.

• Non-eligibility rate [Срок оценки: Through study completion, an average of 3 years]
• Proportion of included but untreated patients [Срок оценки: 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 [Срок оценки: Baseline and 15 months post-randomisation]
• Proportion of patients initiating MBT-TF within three months of recruitment [Срок оценки: Through study completion, an average of 3 years]
• Number of days between randomisation and first MBT-TF session [Срок оценки: Randomization and First Treatment Day]
• Proportion of missing or incomplete questionnaire responses assessing psychological and social aspects [Срок оценки: Through study completion, an average of 3 years]
• Proportion of losses to follow-up [Срок оценки: Through study completion, an average of 3 years]
• Treatment completion rate [Срок оценки: Through study completion, an average of 3 years]
• Mean number of sessions attended [Срок оценки: Through study completion, an average of 3 years]
• Patient expectation and credibility score [Срок оценки: At baseline and at 15 months post randomisation]
• Patient satisfaction score [Срок оценки: 15 months post-randomization]
• Frequency of serious adverse events [Срок оценки: Baseline, 9 months, 15 months, 18 months post randomisation]