Randomized Controlled Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Suicidal Ideation
研究概览
简要总结
When in crisis, people with borderline personality disorder (BPD) frequently seek care in emergency departments (EDs) often presenting with suicide and self-harm behaviour. There is no established evidence-based brief treatment for patients with BPD in ED settings, however a 4-session treatment for people with personality disorders in ED settings was tested in Australia and showed promising results in reducing health care use and improving symptoms. A recent pilot feasibility randomized controlled trial (RCT) comparing this 4-session treatment to treatment as usual was conducted at the Centre for Addiction and Mental Health and preliminary findings have shown that the treatment is feasible to deliver and acceptable to both patients and clinicians. The proposed fully powered RCT will build on this pilot data to assess the efficacy of delivering this 4-session intervention in the ED for people with BPD who present with suicidal ideation or self-harm with the aim of reducing emergency health care use and improving BPD symptoms, functioning and quality of life.
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
- Single (Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be deemed to have capacity to provide informed consent;
- •Must sign and date the informed consent form;
- •Stated willingness to comply with all study procedures;
- •Aged 16 or older;
- •Presenting to ED with self-harm and/or suicidal ideation;
- •Meeting criteria for BPD on the International Personality Disorders Examination (IPDE).
- •Endorsing a score of 1 or greater on the Suicide Ideation Attributes Scale (SIDAS).
排除标准
- •Meeting DSM-5 criteria for schizophrenia spectrum disorder or bipolar disorder I mania based on the Structured Clinical Interview for DSM-5 (SCID-5);
- •Severe alcohol or substance use disorder based on the Structured Clinical Interview for DSM-5 (SCID-5) requiring medical detoxification or residential treatment.
- •IQ < 70 based on the Test of Premorbid Functioning (TOPF).
研究组 & 干预措施
Treatment As Usual
Access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
干预措施: Treatment as usual (Behavioral)
Gold Card Intervention
A 4-session manualized intervention consisting of weekly scheduled 50-minute 1:1 sessions focused on psycho-education, here-and-now problem solving and safety planning. One of the sessions can involve a significant other to provide psychoeducation about the disorder and to facilitate support.
干预措施: Gold Card Intervention (Behavioral)
结局指标
主要结局
Suicidal Ideation
时间窗: 6 Month Follow Up
Suicidal Ideation Attributes Scale (SIDAS): is a self-report questionnaire that assesses history and severity of suicidal behaviour and ideation. Scores range from 0-50 with lower scores indicating less suicidal ideation.
次要结局
- Suicidal Ideation(3 Month Follow Up)
- Health Care Use(3 and 6 Month Follow Up)
- Borderline Personality Disorder Symptoms(3 and 6 Month Follow Up)
- Self-Harm Behavior(3 and 6 Month Follow Up)
- Emotion Regulation(3 and 6 Month Follow Up)
- Depressive Symptoms(3 and 6 Month Follow Up)
- Functioning(3 and 6 Month Follow Up)
- Quality of Life(3 and 6 Month Follow Up)
研究者
Anne Sonley
Associated Scientist
Centre for Addiction and Mental Health