Center for Care Delivery and Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minnesota, USA.
Department of Medicine, University of Minnesota Medical School, Minnesota, USA.
Trials. 2022 Mar 30;23(1):243. doi: 10.1186/s13063-022-06183-2.
Posttraumatic stress disorder occurs in as many as one in five combat veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Trauma-focused treatments, such as Prolonged Exposure, result in clinically significant symptom relief for many. Adherence to these treatments (i.e., session attendance and homework compliance) is vital to ensuring recovery but can be challenging for patients. Engaging families in veterans' treatment could prove to be an effective strategy for promoting treatment adherence while also addressing long-standing calls for better family inclusion in treatment for posttraumatic stress disorder. This paper describes the methods of a pragmatic randomized controlled trial designed to evaluate if family inclusion in Prolonged Exposure can improve treatment adherence.
One hundred fifty-six veterans, with clinically significant symptoms of posttraumatic stress disorder, will be randomized to receive either standard Prolonged Exposure or Prolonged Exposure enhanced through family inclusion (Family-Supported Prolonged Exposure) across three different VA facilities. Our primary outcomes are session attendance and homework compliance. Secondary outcomes include posttraumatic stress disorder symptom severity, depression, quality of life, and relationship functioning. The study includes a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in Prolonged Exposure within VA.
While the importance of family involvement in posttraumatic stress disorder treatment is non-controversial, there is no evidence base supporting best practices on how to integrate families into PE or any other individually focused trauma-focused treatments for posttraumatic stress disorder. This study is an important step in addressing this gap, contributing to the literature for both retention and family involvement in trauma-focused treatments.
ClinicalTrials.gov NCT03256227 . Registered on August 21, 2017.
多达五分之一的参战老兵会出现创伤后应激障碍,这种障碍会给个人、他们的家庭和整个社会带来诸多负面的长期后果。以延长暴露疗法为代表的针对创伤的治疗方法,使许多患者的症状得到了显著的缓解。但这些治疗方法的坚持(即参加治疗、完成家庭作业)对于确保康复至关重要,却可能对患者构成挑战。让家庭成员参与退伍军人的治疗,可能是一个有效的策略,既能促进治疗的坚持,也能满足长期以来让家庭成员更好地参与创伤后应激障碍治疗的呼吁。本文介绍了一项实用随机对照试验的方法,旨在评估将家庭成员纳入延长暴露疗法是否能提高治疗的坚持度。
将 156 名有明显创伤后应激障碍症状的退伍军人随机分为两组,分别接受标准的延长暴露疗法或通过家庭成员参与(家庭支持的延长暴露)增强的延长暴露疗法,在三个不同的退伍军人事务部机构进行。我们的主要结果是治疗出席和家庭作业完成情况。次要结果包括创伤后应激障碍症状严重程度、抑郁、生活质量和关系功能。该研究包括一个同期的过程评估,以确定在退伍军人事务部实施中家庭成员参与延长暴露的潜在促进因素和障碍。
虽然家庭成员参与创伤后应激障碍治疗的重要性没有争议,但目前没有证据支持如何将家庭纳入延长暴露疗法或任何其他针对创伤后应激障碍的个体聚焦的创伤治疗的最佳实践。这项研究是解决这一差距的重要一步,为创伤治疗中的保留和家庭参与文献做出了贡献。
ClinicalTrials.gov NCT03256227。于 2017 年 8 月 21 日注册。