The (Cost-)Effectiveness of Generalist (GIT-PD) Versus Specialist Treatment (MBT/ST) for Severe Personality Disorders (the P-DAET Study): a Pragmatic Randomized Controlled Non-Inferiority Trial.'
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 358
- 试验地点
- 5
- 主要终点
- Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
研究概览
简要总结
The goal of this clinical trial is to investigate if generalist treatment (GIT-PD) is non-inferior in improving level op personality functioning compared to specialist treatment (MBT/ST) in patients with severe personality disorders. The main questions it aims to answer are:
- Is generalist treatment (GIT-PD) non-inferior in improving level of personality functioning compared to specialist treatment (MBT/ST) in patients suffering from severe personality disorders (PD)?
- What patient characteristics predict which patients will benefit more from specialist or generalist treatment?
Participants will be randomized to either specialist or generalist treatment. Interventions included in specialist treatment are Mentalization-Based Treatment (MBT) and Schema Therapy (ST). Generalist treatment will be offererd following the principles of the Guideline-Informed Treatment for Personality Disorders (GIT-PD), a principle-driven treatment framework based upon common factors and allowing personalized treatment according to patients' needs. All participating institutions offer GIT-PD and MBT and/or ST. Before, during and after following this treatment participants will complete measurements at 8 distinct time points.
Participants will be asked to:
- complete a range of instruments at baseline to enable the construction of a personalized advantage index to predict treatment response based on patient characteristics
- complete questionnaires at all 7 post-randomization time points
- undergo a semi-structured interview at 3 time points
- follow treatment for personality disorders (either GIT-PD or MBT/ST)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •'severe' or 'extreme' personality disorder (PD) according to the alternative model for PDs
排除标准
- •legal incapacity
- •Any mental state disorder that requires prior treatment
研究组 & 干预措施
Specialist Treatment for Severe Personality Disorders
Participants will receive specialist treatment for severe personality disorders. Specifically, the type of treatment will be either mentalization-based treatment (MBT) or schema therapy (ST), depending on local availbility, treatment history and shared-decision making. Both MBT and ST must adhere to the protocol and minimum dosage described in respective effect studies published on MBT or ST.
干预措施: Schema therapy (Behavioral)
Specialist Treatment for Severe Personality Disorders
Participants will receive specialist treatment for severe personality disorders. Specifically, the type of treatment will be either mentalization-based treatment (MBT) or schema therapy (ST), depending on local availbility, treatment history and shared-decision making. Both MBT and ST must adhere to the protocol and minimum dosage described in respective effect studies published on MBT or ST.
干预措施: Mentalization-based treatment (Behavioral)
Generalist Treatment for Severe Personality Disorders
Participants will receive a generalist treatment for severe personality disorders. Specificially, the Guideline-Informed Treatment for Personality Disorders (GIT-PD). Sites can only participate in this study, if they offer a GIT-PD programme of lower dosage than the specialist intervention offered at the same site.
干预措施: Guideline-informed treatment for personality disorders (Behavioral)
结局指标
主要结局
Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0)
时间窗: From enrollment to the follow-up assessment 30 months after the start of treatment.
The LPFS-BF 2.0 is a self-report questionnaire consisting of 12 items (Weekers et al., 2018). Each item reflects a basic underlying impairment related to the 12 features of personality functioning according to Criterium A of the AMPD such as identity, self-direction, intimacy and relational functioning. The LPFS-BF 2.0 offers a severity index for personality pathology making it suitable for measuring treatment effects. Each item is scored on a scale from 1 (=very false or often false) to 4 (=very true or often true). Therefore, participants achieve a total score between 12 and 48 representing the severity of impairment in personality functioning. Data collection is done digitally via Castor or with pen and paper, based on participants preference. Pen and paper results are copied into Castor by hand by research assistants. Raw data is digitalized and stored on a local drive.
Semi-structured Interview for Personality Functioning (STiP-5.1)
时间窗: From enrollment to the follow-up assessment 30 months after the start of treatment.
The STiP-5.1 is a semi-structured clinical interview that provides a multi-item assessment of the severity of personality impairments according to the Level of Personal Functioning Scale (LPFS) of the AMPD included in Section III of DSM-5 (APA, 2013). The interviewer should rate the severity of each facet on a scale ranging between 'little to no impairment' (0) to 'extreme impairment' (4). It takes 45 minutes on average to administer the interview. A total score between 0 and 48 is given to indicate the participants global level of personality functioning . We administer the STiP-5.1 at 3 distinct time points. At the start and end of treatment and after 1 year follow up. All interviews are done by blinded research assistants, and the scores are directly logged in Castor. Interviews will be done either face to face or via video call.
次要结局
- Severity Indices of Personality Problems - Short Form (SIPP-SF)(From enrollment to the follow-up assessment 30 months after the start of treatment.)
- Brief Symptom Inventory (BSI)(From enrollment to the follow-up assessment 30 months after the start of treatment.)
- Columbia Suicide Severity Rating Scale Screen Version (C-SSRS)(From enrollment to the follow-up assessment 30 months after the start of treatment.)
- SCID-5-PQ(From enrollment to the follow-up assessment 30 months after the start of treatment.)
- WHO Disability Assessment Schedule (WHODAS 2.0)(From enrollment to the follow-up assessment 30 months after the start of treatment.)
- EQ-5D-5L(From enrollment to the follow-up assessment 30 months after the start of treatment.)
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(From enrollment to the follow-up assessment 30 months after the start of treatment.)
- Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P for Adults)(From enrollment to the follow-up assessment 30 months after the start of treatment.)