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

ConditionsBorderline Personality Disorder (BPD)PTSD - Post Traumatic Stress Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEva Rüfenacht

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Mentalization-Based Treatment

    Other intervention

    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.

  • Trauma-Focused Mentalization-Based Treatment

    Other intervention

    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).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Stardard Mentalization-Based TreatmentActive comparator 1 intervention
Group B: Trauma-Focused Mentalization-Based TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

Proportion of recruited eligible patients

Time frame
Through study completion, an average of 3 years

Secondary outcomes

1

Non-eligibility rate

proportion of eligible patients not included

Time frame
Through study completion, an average of 3 years
2

Proportion of included but untreated patients

Screening failures

Time frame
Through study completion, an average of 3 years
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eva Rüfenacht

Lead sponsor

University Hospital, Geneva

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: