NCT02849431撤回不适用
Mindfulness Approach for Adults Experiencing Borderline Personality Disorder; Supporting the Management of Intense and Fluctuating Emotions, a Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Participant retention in percent
研究概览
简要总结
This study explores the feasibility of a mindfulness-based intervention for people with a diagnosis of borderline personality disorder.
详细描述
This is an uncontrolled feasibility trial of an eight-week mindfulness-based intervention for people with a diagnosis of borderline personality disorder. A battery of measures will be administered at baseline, in a time window of six to zero weeks prior to the start of the intervention. Outcome measures will be repeated in the two weeks after the end of the eight-week intervention, along with a qualitative interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Are on the caseload of a United Kingdom National Health Service Assessment and Treatment Service in the recruitment area and have had contact with that service in the past three months
- •Have received the diagnosis of Borderline Personality Disorder from a suitably qualified health care professional, and continue to meet criteria for this diagnosis according to the SCID-II (Structured Clinical Interview for DSM Disorders Version II) at their screening assessment
- •Have sufficient English language speaking and comprehension abilities to access group discussions and hand-out materials
- •Have not previously engaged in a mindfulness-based intervention. As in other similar trials, a minimum dose has been operationally defined as having undertaken 50% or more of a mindfulness-based intervention delivered face-to-face by a suitably qualified health care professional
- •Are not currently receiving, nor have plans to receive any other form of psychological therapy during the course of the study
排除标准
- •Have psychosis
- •Misuse alcohol or drug to a level that requiring detox
- •Have a intellectual disability
- •Present a high level of risk requiring inpatient management at the time of their screening assessment
研究组 & 干预措施
Mindfulness-based intervention
Experimental
干预措施: Mindfulness-based intervention (Behavioral)
结局指标
主要结局
Participant retention in percent
时间窗: At post-intervention (i.e. 8 weeks after the start of the intervention).
The number of participants who remain in the study at the post-intervention time point divided by the number of participants who are recruited into the study at baseline, expressed as a percentage
次要结局
- Change from baseline at post-intervention in the Difficulties in the Emotion Regulation Scale (DERS)(Post-intervention (i.e. 8 weeks after the start of the intervention))
- Change from baseline at post-intervention in the Patient Health Questionnaire (PQH-9).(Post-intervention (i.e. 8 weeks after the start of the intervention))
- Change from baseline at post-intervention in the Generalized Anxiety Disorder Scale (GAD-7)(Post-intervention (i.e. 8 weeks after the start of the intervention))
- United Kingdom National Health Service Friends and Family Test (FFT).(Post-intervention (i.e. 8 weeks after the start of the intervention))
- Elliot et al.'s (2001) Change Interview.(Post-intervention (i.e. 8 weeks after the start of the intervention))
- Recruitment rate(Baseline)
- Qualitative feedback from participants on intervention acceptability in response to questions 6 and 7 of Elliot et al.'s (2001) Change Interview(Post-intervention (i.e. 8 weeks after the start of the intervention))
- Change from baseline at post-intervention in the Five-Facet Mindfulness Questionnaire (FFMQ)(Post-intervention (i.e. 8 weeks after the start of the intervention))
研究者
研究点 (1)
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