Physical Activity in People With Borderline Personality Disorder (PABORD): a Study Protocol for a Pilot Randomised Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction in Borderline Personality Disorder Symptomatology
研究概览
简要总结
The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are:
- Does a structured PA program reduce clinical symptoms in patients with BPD?
- How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?
Participants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group).
Researchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6).
详细描述
Background and Objectives This randomised controlled trial (RCT) aims to investigate the effects of a structured physical activity (PA) programme on the symptoms of outpatients who meet DSM-5-TR criteria for Borderline Personality Disorder (BPD). The hypothesis is that these symptoms may improve over the course of the PA treatment. The primary objective is to evaluate the efficacy of a structured PA intervention on reducing clinical symptoms and improving PA-related parameters compared to a psychoeducational intervention on healthy lifestyle.
Study Design The PABORD RCT is a controlled study involving female outpatients aged 18 to 40 years with a BPD diagnosis. Participants will be informed about the study's objectives, procedures, and the potential risks and benefits of the proposed treatments. After confirming inclusion/exclusion criteria, obtaining signed informed consent, and reviewing the data processing information, participants will be randomly assigned to two groups. This trial will be conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013).
Treatment Arms
The study involves two treatment arms:
Intervention Group (n=30): Participants will engage in a 12-week structured PA programme, preceded by three weekly psychoeducational sessions focused on nutrition. This includes three 60-minute PA sessions per week supervised by a personal trainer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender.
- •Age between 18 and 40 years.
- •Primary diagnosis of Borderline Personality Disorder (BPD) according to the diagnostic criteria of the DSM-
- •Outpatient treatment.
- •Ability to provide written informed consent.
- •Good understanding of the Italian language.
- •Proficiency in using a smartphone.
- •The presence of ongoing pharmacological and/or psychotherapeutic treatments is not considered an exclusion criterion.
排除标准
- •Current pregnancy or planning a pregnancy within the next 6 months.
- •Acute psychotic symptoms.
- •Comorbidities with Eating Disorders, Substance Use Disorder, and Bipolar Disorder.
- •Absolute contraindications to physical exercise, such as medical conditions that interfere with the ability to perform exercise or with the physiological response to exercise tests, e.g., the use of beta-adrenergic blocking agents.
结局指标
主要结局
Reduction in Borderline Personality Disorder Symptomatology
时间窗: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
The Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) scale measures borderline personality symptomatology. A reduction in score of at least 3.5 indicates improvement, as demonstrated in previous pharmacological treatment studies. Administered at baseline, end of treatment (T3), and end of follow-up (T6) to assess the impact of structured PA treatment on DBP symptomatology. Evaluators blinded to group assignment will obtain and examine outcome measurements.
Improvement of BPD-Related Symptomatology
时间窗: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Additional primary outcomes include psychological variables associated with BPD, including sleep hygiene, mood changes, anxiety, impulsivity, and disability impact on daily functioning. Assessment tools include the Experience Sampling Method (ESM), Beck Depression Inventory short form (BDI-13), State-Trait Anxiety Inventory (STAI-Y), Impulsive Behavior Scale (UPPS-P), World Health Organization Disability Assessment Schedule (WHODAS 2.0), and Premenstrual Symptom Screening Tool (PSST). ESM utilizes a custom app for real-time evaluation, while other tools are self-reported questionnaires administered at different time points throughout the study.
次要结局
- Reduction of Premenstrual Symptom Exacerbation(Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24))
- Improvement of Physical Activity-Related Parameters(Baseline (start of the study), week 6 (half of the 3-months treatment), end of 3-months treatment (week 12), end of 3-months follow-up (week 24))