Pilot Study for the Evaluation of a New Psychotherapeutic Treatment for Borderline Personality Disorder Patients With Post-traumatic Stress Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Mentalization-Based Treatment, Trauma-Focused Mentalization-Based Treatment.
- Who it may be relevant to
- Registry conditions: Borderline Personality Disorder (BPD), PTSD - Post Traumatic Stress Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other 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. - Other 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).
Primary outcome measures
- Recruitment rate [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Switzerland · 1 center
- University Hospitals of Geneva — Geneva
Identifiers
NCT: NCT07305155 · 2025-01307