Pigeon Wilfred R, Heffner Kathi L, Crean Hugh, Gallegos Autumn M, Walsh Patrick, Seehuus Martin, Cerulli Catherine
Sleep and Neurophysiology Research Laboratory, Department of Psychiatry, University of Rochester Medical Center, Rochester, NY USA; U.S. Department of Veterans Affairs Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center, Canandaigua, NY USA.
Sleep and Neurophysiology Research Laboratory, Department of Psychiatry, University of Rochester Medical Center, Rochester, NY USA.
Contemp Clin Trials. 2015 Nov;45(Pt B):252-260. doi: 10.1016/j.cct.2015.08.019. Epub 2015 Sep 4.
Sleep disturbance is a common feature of posttraumatic stress disorder (PTSD), but is not a focus of standard PTSD treatments. Psychological trauma exposure is associated with considerable physical and mental health morbidity, possibly due to the alterations in neuroendocrine function and inflammation observed in trauma exposed individuals. Although PTSD treatments are efficacious, they are associated with high drop-out rates in clinical trials and clinical practice. Finally, individuals with PTSD stemming from exposure to interpersonal violence represent an especially under-treated population with significant sleep disturbance. Community-based participatory research was utilized to design and prepare a clinical trial that randomizes recent survivors of interpersonal violence who have PTSD, depression, and insomnia to receive either: (1) Cognitive Behavioral Therapy for Insomnia (CBTi) followed by Cognitive Processing Therapy (CPT) for trauma, or (2) attention control followed by CPT. Outcome measures include subjective and objective measures of sleep, clinician-administered PTSD and depression scales, inflammatory cytokines, and salivary cortisol. Assessments are conducted at baseline, following the sleep or control intervention, and again following CPT. The design allows for: (1) the first test of a sleep intervention in this population; (2) the comparison of sequenced CBTi and CPT to attention control followed by CPT, and (3) assessing the roles of neuroendocrine function, inflammatory processes, and objective sleep markers in mediating treatment outcomes. The study's overarching hypothesis is that treating insomnia will produce reduction in insomnia, PTSD, and depression severity, allowing patients to more fully engage in, and derive optimal benefits from, cognitive processing therapy.
睡眠障碍是创伤后应激障碍(PTSD)的常见特征,但并非标准PTSD治疗的重点。心理创伤暴露与相当多的身心健康问题相关,这可能是由于在遭受创伤的个体中观察到的神经内分泌功能和炎症改变所致。尽管PTSD治疗是有效的,但在临床试验和临床实践中,它们与高脱落率相关。最后,因人际暴力暴露而患有PTSD的个体是一个特别未得到充分治疗的群体,存在严重的睡眠障碍。基于社区的参与性研究被用于设计和筹备一项临床试验,该试验将近期遭受人际暴力且患有PTSD、抑郁症和失眠症的幸存者随机分为两组,分别接受:(1)失眠认知行为疗法(CBTi),随后接受创伤认知加工疗法(CPT);或(2)注意力控制,随后接受CPT。结果测量包括睡眠的主观和客观测量、临床医生评定的PTSD和抑郁量表、炎性细胞因子以及唾液皮质醇。评估在基线、睡眠或对照干预后以及CPT后再次进行。该设计允许:(1)首次对该人群进行睡眠干预测试;(2)将序贯CBTi和CPT与注意力控制加CPT进行比较;(3)评估神经内分泌功能、炎症过程和客观睡眠指标在介导治疗结果中的作用。该研究的总体假设是,治疗失眠将减轻失眠、PTSD和抑郁的严重程度,使患者能够更充分地参与认知加工疗法并从中获得最佳益处。