Depp Colin, Ehret Blaire, Villa Jennifer, Perivoliotis Dimitri, Granholm Eric
Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.
VA San Diego Healthcare System, San Diego, CA, United States.
JMIR Res Protoc. 2021 Feb 8;10(2):e14378. doi: 10.2196/14378.
People with serious mental illnesses (SMIs) are at exceptionally high risk for lifetime suicidal ideation and behavior compared with the general population. The transition period between urgent evaluation and ongoing care could provide an important setting for brief suicide-specific interventions for SMIs. To address this concern, this trial, SafeTy and Recovery Therapy (START), involves a brief suicide-specific cognitive behavioral intervention for SMIs that is augmented with mobile phone interactions.
The primary aim of this pilot trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention.
A 6-month pilot trial with 70 participants with a diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, and current active suicidal ideation were randomized to START or START with mobile augmentation. START consists of 4 weekly sessions addressing early warning signs and triggers, symptoms influencing suicidal thinking, and social relationships. Recovery planning is followed by biweekly telephone coaching. START with mobile augmentation includes personalized automated cognitive behavioral therapy scripts that build from in-person content. Participants were evaluated at baseline, 4 weeks (end of in-person sessions), 12 weeks (end of telephone coaching), and 24 weeks. In addition to providing point estimates of feasibility and acceptability, the primary outcome of the trial was the change in severity of suicidal ideation as measured with the Scale for Suicide Ideation (SSI) and secondary outcome included the rate of outpatient engagement.
The trial is ongoing. Feasibility and acceptability across conditions will be assessed using t tests or Mann-Whitney tests or chi-square tests. The reduction of SSI over time will be assessed using hierarchical linear models.
The design considerations and results of this trial may be informative for adapted suicide prevention in psychotic disorders in applied community settings.
ClinicalTrials.gov NCT03198364; http://clinicaltrials.gov/ct2/show/NCT03198364.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14378.
与普通人群相比,患有严重精神疾病(SMI)的人终生出现自杀意念和行为的风险异常高。在紧急评估和持续护理之间的过渡阶段,可能为针对SMI患者开展简短的特定自杀干预提供重要契机。为解决这一问题,“安全与康复治疗”(START)试验针对SMI患者开展了一项简短的特定自杀认知行为干预,并辅以手机互动。
这项试点试验的主要目的是评估该干预措施的可行性、可接受性和初步效果。
一项为期6个月的试点试验,将70名诊断为双相情感障碍、精神分裂症或分裂情感性障碍且目前有活跃自杀意念的参与者随机分为START组或手机增强版START组。START包括4次每周一次的课程,内容涉及预警信号和触发因素、影响自杀思维的症状以及社会关系。康复计划之后是每两周一次的电话辅导。手机增强版START包括根据面对面课程内容生成的个性化自动化认知行为疗法脚本。在基线、4周(面对面课程结束时)、12周(电话辅导结束时)和24周对参与者进行评估。除了提供可行性和可接受性的点估计值外,试验的主要结局是用自杀意念量表(SSI)测量的自杀意念严重程度的变化,次要结局包括门诊参与率。
试验正在进行中。将使用t检验、曼-惠特尼检验或卡方检验评估各条件下的可行性和可接受性。将使用分层线性模型评估SSI随时间的降低情况。
该试验的设计考量和结果可能为在应用社区环境中对精神障碍进行适应性自杀预防提供参考。
ClinicalTrials.gov NCT03198364;http://clinicaltrials.gov/ct2/show/NCT03198364。
国际注册报告识别号(IRRID):DERR1-10.2196/14378。