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

NCT07305155 | Not Yet Recruiting DMC

• 1 other identifier: 2025-01307
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Borderline Personality Disorder (BPD); PTSD - Post Traumatic Stress Disorder

Keywords

Borderline Personality Disorder; Post Traumatic Stress Disorder; Mentalization-based treatment; trauma-focused mentalization-based treatment

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  Proportion of recruited eligible patients

  Through study completion, an average of 3 years

Secondary Outcomes (15)

• Non-eligibility rate

  Through study completion, an average of 3 years

• Proportion of included but untreated patients

  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

Study Arms (2)

Stardard Mentalization-Based Treatment

ACTIVE COMPARATOR

Other: Standard Mentalization-Based Treatment

Trauma-Focused Mentalization-Based Treatment

EXPERIMENTAL

Other: Trauma-Focused Mentalization-Based Treatment

Interventions

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.

Also known as: TAU (Treatment As Usual), Standard MBT

Stardard Mentalization-Based Treatment

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).

Trauma-Focused Mentalization-Based Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eva Rüfenacht: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Eva Rüfenacht, MD

CONTACT

+41223054552; EvaNina.Rufenacht@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physician, Head of the Emotion Regulation Disorders Unit , Principal Investigator

Model Details: This study is a monocentric, two-arm feasibility randomised controlled trial (RCT), comparing the intervention (MBT-TF) with TAU (standard MBT).

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 26, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CH (1)