Department of Psychiatry & Human Behavior, Alpert Medical School of Brown University, Box G-BH, Providence, RI, 02912, USA.
VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, 830 Chalkstone Boulevard, Providence, RI, 02908, USA.
Trials. 2020 Nov 12;21(1):924. doi: 10.1186/s13063-020-04870-6.
At least 17 veterans die every day from suicide. Although existing treatments such as brief cognitive behavioral therapy (BCBT) have been found to reduce suicide attempts in military personnel, a number of patients go on to attempt suicide after completing therapy. Thus, finding ways to enhance treatment efficacy to reduce suicide is critical. Repetitive transcranial magnetic stimulation (TMS) is a noninvasive technique that can be used to stimulate brain regions that are impaired in suicidal patients, that has been successfully used to augment treatments for psychiatric disorders implicated in suicide. The goal of this study is to test whether augmenting BCBT with TMS in suicidal veterans reduces rates of suicidal ideation, attempts, and other deleterious treatment outcomes.
One hundred thirty veterans with a suicide plan or suicidal behavior in the prior 2 weeks will be recruited from inpatient and outpatient settings at the Providence VA Medical Center in the USA. Veterans will be randomly assigned to receive 30 daily sessions of active or sham TMS in concert with a 12-week BCBT protocol in a parallel group design. Veterans will complete interviews and questionnaires related to psychiatric symptoms, suicidal ideation and behavior, treatment utilization, and functioning during a baseline assessment prior to treatment, at treatment endpoint, and 6- and 12-month follow-ups. Primary analyses will use mixed effect regressions to examine effects of treatment condition on suicidal behaviors, improvements in psychosocial functioning, and psychiatric hospitalization. Similar models as well as exploratory latent growth curve analyses will examine mediators and moderators of treatment effects.
This protocol provides a framework for designing multilayered treatment studies for suicide. When completed, this study will be the first clinical trial evaluating the efficacy of augmenting BCBT for suicide with TMS. The results of this trial will have implications for treatment of suicide ideation and behaviors and implementation of augmented treatment designs. If positive, results from this study can be rapidly implemented across the VA system and will have a direct and meaningful impact on veteran suicide.
This study was registered prior to participant enrollment with ClinicalTrials.gov NCT03952468 . Registered on May 16, 2019.
Robert O'Brien (VA Health Services R&D), robert.obrien7@va.gov.
每天至少有 17 名退伍军人自杀身亡。尽管现有的治疗方法，如简短认知行为疗法（BCBT），已被发现可减少军人自杀企图，但仍有许多患者在完成治疗后继续尝试自杀。因此，寻找提高治疗效果以降低自杀率的方法至关重要。重复经颅磁刺激（TMS）是一种非侵入性技术，可用于刺激自杀患者受损的大脑区域，已成功用于增强与自杀相关的精神疾病的治疗。本研究的目的是测试在有自杀计划或在过去 2 周内有自杀行为的退伍军人中，用 TMS 增强 BCBT 是否会降低自杀意念、自杀企图和其他不良治疗结果的发生率。
将从美国普罗维登斯退伍军人医疗中心的住院和门诊环境中招募 130 名有自杀计划或在过去 2 周内有自杀行为的退伍军人。退伍军人将被随机分配接受 30 次每日的主动或假 TMS 治疗，并与 12 周的 BCBT 方案一起进行平行组设计。退伍军人将在治疗前的基线评估、治疗终点以及 6 个月和 12 个月的随访中完成与精神症状、自杀意念和行为、治疗利用以及功能相关的访谈和问卷调查。主要分析将使用混合效应回归来检验治疗条件对自杀行为、心理社会功能改善以及精神科住院的影响。类似的模型以及探索性潜在增长曲线分析将检验治疗效果的中介和调节因素。
该方案为设计用于治疗自杀的多层治疗研究提供了框架。当完成时，这项研究将是首个评估用 TMS 增强 BCBT 治疗自杀的疗效的临床试验。该试验的结果将对治疗自杀意念和行为以及实施增强治疗设计产生影响。如果结果为阳性，该研究的结果可以迅速在退伍军人事务部系统中实施，并将对退伍军人自杀产生直接而有意义的影响。
本研究在参与者入组前已在 ClinicalTrials.gov 注册，NCT03952468。于 2019 年 5 月 16 日注册。
Robert O'Brien（VA 医疗保健服务 R&D），robert.obrien7@va.gov。
