Treating Suicidality Remotely: a Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Suicide Prevention Delivered Via Chat or Phone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Number of suicide attempts
研究概览
简要总结
Background: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to get professional help. Online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. This is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa.
Methods: A fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the Netherlands and randomized with an allocation ratio of 1:1 to either Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale. Secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up.
Discussion: If remote BCBT-SP proves effective, the findings of this study will add to the evidence base of BCBT-SP as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants are not blind to the treatment condition, but are unaware which is the experimental condition and which the control condition.
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
- •16 years or older
- •Currently living in The Netherlands
- •Any type of STBs in the past 4 weeks
排除标准
- •Insufficient mastery of the Dutch language
- •Previously engaged in 113 Suicide Prevention's Online Therapy or Self-help course
- •Currently seeing a mental health professional at least once every 3 weeks, other then a general practitioner or general practice based nurse practitioner ('POH-GGZ')
- •Not able to engage in online therapy, for instance because of severe mood disorders or psychotic symptoms, based on the clinical impression of the research assistant and a supervisor
研究组 & 干预措施
Remote Brief Cognitive Behavioral Therapy for Suicide Prevention
Participants in the experimental condition will be treated with online CBT-SP, a personalized intervention of approximately 12 sessions via chat or phone, in which therapist and client create a safety plan, try to restrict the access to lethal means and use a narrative assessment of a recent suicidal crisis to create a case formulation. This case formulation is then used to choose from several treatment modules, such as dealing with unhelpful thoughts and reducing sleep problems.
干预措施: Brief Cognitive Behavioral Therapy for Suicide Prevention (Behavioral)
Remote Semi-guided self-help course
Participants in the control group will be treated with a self-help course, in which they are given psychoeducation on suicidal thoughts, create a safety plan and are thought several techniques from cognitive therapy, such as cognitive restructuring and worry times. The course consists of 6 sessions, on which subjects receive feedback from a therapist. In this study, feedback will be given in a live conversation with the therapist via chat or phone, instead of via e-mail, to increase safety and reduce the difference in attention between the groups.
干预措施: Living under control (Behavioral)
结局指标
主要结局
Number of suicide attempts
时间窗: 18-months follow-up
Number of fatal and non-fatal suicide attempts, identified through the Columbia Suicide Severity Rating Scale (C-SSRS; non-fatal attempts), a contact provided by the participant or Statistics Netherlands (fatal attempts).
次要结局
- Co-occuring mental health issues(18-months follow-up)
- Severity of suicidal ideation(18-months follow-up)
- Severity of suicidal Thoughts and Behaviors Composite(18-months follow-up)
- Adverse effects(post-treatment (approximately 12 weeks after the start of treatment))
- Quality of life(18-months follow-up)
- Treatment satisfaction(post-treatment (approximately 12 weeks after the start of treatment))