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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Borderline Personality Disorder (BPD); PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Other: Standard Mentalization-Based Treatment; Other: Trauma-Focused Mentalization-Based Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Rüfenacht, MD; Phone Number: +41223054552; Email: EvaNina.Rufenacht@hug.ch

Study Locations

• Switzerland
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stardard Mentalization-Based Treatment	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 Names: TAU (Treatment As Usual); Standard MBT
Experimental: Trauma-Focused Mentalization-Based Treatment	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Proportion of recruited eligible patients	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	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	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
Frequency of serious adverse events		Baseline, 9 months, 15 months, 18 months post randomisation
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
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

Collaborators and Investigators

• Sponsor: Eva Rüfenacht

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Borderline Personality Disorder; Post Traumatic Stress Disorder; Mentalization-based treatment; trauma-focused mentalization-based treatment
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Personality Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Borderline Personality Disorder; Combat Disorders; Therapeutics
• Other Study ID Numbers: 2025-01307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No