A Quasi-experimental Pragmatic Trial Evaluating a Tailored Healthcare Service for Patients With Borderline Personality Disorder: Borderline Personality Disorder Athens Study (BPDAS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- Suicide Harm Inventory
研究概览
简要总结
A quasi-experimental pragmatic trial was developed to evaluate a specific health-care service for the treatment of biporal personality disorder (BPD) patients.The effectiveness and economic evaluation (cost-effectiveness and cost-utility) of this specific health-care service as it is offered in every-day clinical practice will be assesed. The main hypothesis of the particular study is that the specific health-care service for the treatment of BPD patients has better efficacy and cost-effectiveness than the treatment as usual.
Furthermore, two additional substudies will be performed. The first one is a qualitative study on the experiences of patients and therapists of the specific program as compared to common treatment. The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program.
Patients will be followed for 2 years.
详细描述
There is a lack of studies evaluating the effectiveness of health care services providing treatment for patients with borderline personality disorder). This study is the first to evaluate a psychoanalytically-oriented intervention that is developed specifically for BPD.
A quasi-experimental pragmatic trial for the evaluation of a specific health-care service for BPD patients was developed. The effectiveness and economic evaluation (cost-effectiveness and cost-utility) of a special health service for the treatment of BPD patients as it is offered in the every-day clinical practice will be assessed.
This health-care service is the Specific Therapy Program for BPD patients of the 1st Psychiatric Clinic of the Medical School of the National and Kapodistrian University of Athens. It has provided a wide range of different treatment interventions (outpatient, inpatient and day care).
The main hypothesis of the study is that the specific health-care service for the treatment of BPD patients has better efficacy and cost-effectiveness than the treatment as usual.
Furthermore, two additional substudies will be performed. The first one regards a qualitative study on the experiences of patients and therapists of the specific program and of the TAU. Qualitative data will be collected from interviews and/or focus groups. This study aims to provide information on the aspects of the specific health care service that are more advantageous for the patients. The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program and will be based both on empirical qualitative data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of BPD (diagnosed with Structural Clinical Interview for DSM-5 Personality Disorders; SCID-5-PD and
- •willingness to participate in the study.
排除标准
- •lifetime psychotic disorder (except for a brief psychotic disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, version V, DSM-5, BPD criterion 9,
- •bipolar disorder type I,
- •antisocial personality disorder,
- •severe substance dependence resulting in severe cognitive restrictions during therapy, needing clinical detoxification,
- •IQ below 80,
- •organic brain disease,
- •poor Greek language skills.
结局指标
主要结局
Suicide Harm Inventory
时间窗: Baseline, 6 months, 1 year, 18 months, 2 years
It is an interview designed to ensure accurate collection of data about attempted acts of suicide and incidents of self-harm over a six-month period but does not aim to measure their severity.
Severity of BPD and severe parasuicidal behavior as defined by Bateman and Fonagy (2009).
时间窗: Baseline, 6 months, 1 year, 18 months, 2 years
It is assessed using the Borderline Personality Disorder Severity Index (BPDSI) and the latter is assessed through the number of 1) suicide attempts, 2) life-threatening self-harm behaviors and 3) psychiatric hospital admissions.
次要结局
- Reflective Functioning(Baseline,1 year, 2 years)
- Defense tendency(Baseline,1 year, 2 years)
- Functional Impairments in fields such as work and household(Baseline, 6 months, 1 year, 18 months, 2 years)
- WHODAS II(Baseline, 6 months, 2 years)
- Personality Organisation(Baseline,1 year, 2 years)
- Client Satisfaction Questionnaire(6 months, 1 year, 18 months, 2 years)
- Patients' health-related quality of life(Baseline, 6 months, 1 year, 18 months, 2 years)
- Subjective Quality of Life(Baseline, 6 months, 1 year, 18 months, 2 years)
- Distress caused by interpersonal problems(Baseline, 6 months, 1 year, 18 months, 2 years)
- General psychiatric symptoms present at the time of assessment.(Baseline, 6 months, 1 year, 18 months, 2 years)
研究者
Ioannis A. Malogiannis
Mr Ioannis A. Malogiannis, Head of the BPD Specific Sector
National and Kapodistrian University of Athens