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NCT Number: NCT07305155

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 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: TAU (Treatment As Usual), Standard MBT

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).

Primary outcomes

  1. Recruitment rate

    Time frame: Through study completion, an average of 3 years

    Proportion of recruited eligible patients

Secondary outcomes

  1. Non-eligibility rate

    Time frame: Through study completion, an average of 3 years

    proportion of eligible patients not included

  2. Proportion of included but untreated patients

    Time frame: Through study completion, an average of 3 years

    Screening failures

  3. 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

  4. Proportion of patients initiating MBT-TF within three months of recruitment

    Time frame: Through study completion, an average of 3 years

  5. Number of days between randomisation and first MBT-TF session

    Time frame: Randomization and First Treatment Day

  6. Proportion of missing or incomplete questionnaire responses assessing psychological and social aspects

    Time frame: Through study completion, an average of 3 years

  7. Proportion of losses to follow-up

    Time frame: Through study completion, an average of 3 years

  8. Treatment completion rate

    Time frame: Through study completion, an average of 3 years

    Rate of patients completing 8 months of treatment

  9. Mean number of sessions attended

    Time frame: Through study completion, an average of 3 years

  10. Patient expectation and credibility score

    Time frame: At baseline and at 15 months post randomisation

    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.

  11. Patient satisfaction score

    Time frame: 15 months post-randomization

    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.

  12. Frequency of serious adverse events

    Time frame: Baseline, 9 months, 15 months, 18 months post randomisation

  13. Average therapist adherence scores across sessions for both arms using a standardised adherence scale

    Time frame: 15 months post-randomisation

    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.

  14. Mean change in CAPS-5 total score

    Time frame: At baseline and at 15 months post-randomisation

    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.

  15. Mean change in ITQ CPTSD with clinical checks total symptom score

    Time frame: At baseline and at 15 months post-randomisation

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Rüfenacht, MD

CONTACT

[email protected]

+41223054552

Sponsors and collaborators

Lead sponsor

Eva Rüfenacht

Other

Registry information

Official study 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

Acronym: MBT-TF

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 26, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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