Norman Sonya B, Haller Moira, Spadoni Andrea D, Drummond Sean P A, Risbrough Victoria, Hamblen Jessica L, Trim Ryan S, Blanes Erika X
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States.
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States.
Contemp Clin Trials. 2015 May;42:244-51. doi: 10.1016/j.cct.2015.04.011. Epub 2015 Apr 28.
There is increasing interest in including measures of biological mechanisms as mediators and moderators of treatment outcome in randomized controlled trials (RCT's) of psychotherapy efficacy. However, examining biological mechanisms is often expensive and budget caps of most major funding agencies have remained stable in recent years. The goal of this manuscript is to describe how a psychotherapy efficacy trial is using a model of collaborative, affiliated grants to maximize resources and the potential knowledge to be gained from a single site RCT. Principal results and conclusions: The trial is an ongoing RCT comparing two psychotherapies for the treatment of concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans. Through collaboration with a team of investigators with independently-funded but affiliated grants, measures of select sleep, neurobiological, and genetic biomarkers were integrated into this single site RCT. This model has allowed us to pose research questions regarding the role of biological mechanisms, maximize the utility of recruitment, and be efficient in maximizing knowledge to be gained in a way that would not be possible solely on the funding of a single site RCT. Challenges of this model include high participant burden in regard to assessment and complicated coordinating procedures among studies. Strategies to address these challenges are described.
在心理治疗疗效的随机对照试验（RCT）中，将生物机制的测量作为治疗结果的调节因素和中介因素越来越受到关注。然而，研究生物机制往往成本高昂，而且近年来大多数主要资助机构的预算上限一直保持稳定。本手稿的目的是描述一项心理治疗疗效试验如何使用合作附属资助模式，以最大限度地利用资源，并从单个站点的RCT中获取潜在知识。主要结果和结论：该试验是一项正在进行的RCT，比较两种心理治疗方法对患有创伤后应激障碍（PTSD）和酒精使用障碍（AUD）的退伍军人样本的治疗效果。通过与一组拥有独立资助但附属资助的研究人员合作，将选定的睡眠、神经生物学和遗传生物标志物的测量纳入了这个单个站点的RCT。这种模式使我们能够提出关于生物机制作用的研究问题，最大限度地提高招募的效用，并以一种仅靠单个站点RCT的资助无法实现的方式高效地获取知识。该模式的挑战包括评估方面的高参与者负担以及研究之间复杂的协调程序。文中描述了应对这些挑战的策略。
