创伤后应激反应序列治疗有效性(STEPS)试验:具有基线结果的实用比较有效性试验方案。

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
John C. Fortney , Debra L. Kaysen , Charles C. Engel , Joseph M. Cerimele , John P. Nolan Jr , Erin Chase , Brittany E. Blanchard , Stephanie Hauge , Jared Bechtel , Danna L. Moore , Ashley Taylor , Ron Acierno , Nancy Nagel , Rebecca K. Sripada , Jacob T. Painter , Bryann B. DeBeer , Ellen Bluett , Alan R. Teo , Leslie A. Morland , Patrick J. Heagerty
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引用次数: 0

摘要

背景:目前只有两项疗效试验对创伤后应激障碍(PTSD)的药物治疗和心理治疗进行了正面比较,而且这两项试验都不是在初级医疗机构进行的。因此,在这项实用性试验中,我们比较了初级保健患者随机接受以创伤为重点的简短心理治疗或三种抗抑郁药治疗的结果。此外,由于很少有试验对初始治疗无效患者的后续治疗效果进行研究,因此我们还对那些转换或加强治疗的患者的治疗效果进行了比较:从 7 个联邦合格医疗中心 (FQHC) 和 8 个退伍军人事务部 (VA) 医疗中心的初级保健诊所招募创伤后应激障碍筛查阳性患者(n = 700),并按 1:1:2 的比例随机分配到三种治疗序列中的一种:1) 选择性血清素再摄取抑制剂 (SSRI),然后使用书面暴露疗法 (WET) 进行强化治疗;2) 选择性血清素再摄取抑制剂 (SSRI),然后改用血清素-去甲肾上腺素再摄取抑制剂 (SNRI);或 3) 选择性血清素-去甲肾上腺素再摄取抑制剂 (WET),然后改用选择性血清素再摄取抑制剂 (SSRI)。参与者在基线、6 个月和 12 个月时完成调查。主要结果是创伤后应激障碍症状严重程度,以创伤后应激障碍核对表(PCL-5)来衡量:结果:PCL-5 的平均得分为 52.8(SD = 11.1),表明症状相当严重。对于退伍军人事务部的参保者来说,最常见的令人烦恼的创伤事件是战斗(47.8%),而对于家庭健康服务中心的参保者来说,最常见的创伤事件是其他(28.2%),其次是性侵犯(23.4%)和虐待儿童(19.8%)。只有 22.4% 的人在基线时服用抗抑郁药:结果将有助于医疗系统和临床医生决定为患者提供哪些治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Sequenced treatment effectiveness for posttraumatic stress (STEPS) trial: A protocol for a pragmatic comparative effectiveness trial with baseline results

Background

There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for PTSD, and neither was conducted in primary care. Therefore, this protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused psychotherapy or a choice of three antidepressants. In addition, because there are few trials examining the effectiveness of subsequent treatments for patients not responding to the initial treatment, this pragmatic trial also compares the outcomes of those switching or augmenting treatments.

Method

Patients screening positive for PTSD (n = 700) were recruited from the primary care clinics of 7 Federally Qualified Health Centers (FQHC) and 8 Department of Veterans Affairs (VA) Medical Centers and randomized in the ratio 1:1:2 to one of three treatment sequences: 1) selective serotonin reuptake inhibitor (SSRI) followed by augmentation with Written Exposure Therapy (WET), 2) SSRI followed by a switch to serotonin-norepinephrine reuptake inhibitor (SNRI), or 3) WET followed by a switch to SSRI. Participants complete surveys at baseline, 4 months, and 8 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5).

Results

Average PCL-5 scores (M = 52.8, SD = 11.1) indicated considerable severity. The most common bothersome traumatic event for VA enrollees was combat (47.8%), and for FQHC enrollees was other (28.2%), followed by sexual assault (23.4%), and child abuse (19.8%). Only 22.4% were taking an antidepressant at baseline.

Conclusion

Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients.

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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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