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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Recruitment rate
时间窗: Through study completion, an average of 3 years
Proportion of recruited eligible patients
次要结局
- 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)
- Proportion of losses to follow-up(Through study completion, an average of 3 years)
- Frequency of serious adverse events(Baseline, 9 months, 15 months, 18 months post randomisation)
- Average therapist adherence scores across sessions for both arms using a standardised adherence scale(15 months post-randomisation)
- Proportion of missing or incomplete questionnaire responses assessing psychological and social aspects(Through study completion, an average of 3 years)
- Treatment completion rate(Through study completion, an average of 3 years)
- Mean number of sessions attended(Through study completion, an average of 3 years)
- Patient satisfaction score(At baseline and at 15 months post randomisation)
- Mean change in CAPS-5 total score(At baseline and at 15 months post-randomisation)
- Mean change in ITQ CPTSD with clinical checks total symptom score(At baseline and at 15 months post-randomisation)
研究者
Eva Rüfenacht
Senior Physician, Head of the Emotion Regulation Disorders Unit , Principal Investigator
University Hospital, Geneva