Acupuncture for PTSD in Combat Veterans

针灸治疗退伍军人的创伤后应激障碍

• 批准号: 10038793
• 负责人: Michael Hollifield
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-10-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10038793
• 关键词: Acupuncture Therapy; Advocate; Affect; Afghanistan; Aftercare; Age; Animals; Anxiety; Area; Biological; Biology; Blinking; Characteristics; Chronic Post Traumatic Stress Disorder; Clinical; Clinical Trials; Cognitive Therapy; Coin; Complementary Medicine; Data; Decision Making; Dreams; Dropout; Effectiveness; Ethics; Evidence based intervention; Exclusion Criteria; Expectancy; Experimental Designs; Galvanic Skin Response; Gender; Goals; Guidelines; Heart Rate; Hospitals; Human; Impairment; Individual; Intervention; Iraq; Knowledge; Literature; Measures; Memory; Mental Depression; Minority; Modeling; Monitor; National Institute of Mental Health; Needles; Outcome; Participant; Patients; Peripheral; Pharmaceutical Preparations; Physiology; Pilot Projects; Placebo Control; Placebos; Policy Maker; Post-Traumatic Stress Disorders; Probability; Procedures; Psychophysiology; Psychotherapy; Publishing; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recommendation; Relaxation; Reporting; Research; Research Design; Research Priority; Risk; Sample Size; Sampling; Services; Severities; Side; Signal Transduction; Site; Skin; Sleep; Specific qualifier value; Startle Reaction; Symptoms; Testing; Time; Trauma; Veterans; Vietnam; Waiting Lists; Work; active duty; active method; arm; associated symptom; care seeking; clinical trial participant; combat veteran; computer generated; conditioned fear; desensitization; effective therapy; efficacy evaluation; follow-up; group intervention; heart rate variability; ineffective therapies; interest; member; placebo group; prospective; public health relevance; recruit; response; sensor; traumatic event; treatment duration; treatment response; trial comparing

 DESCRIPTION (provided by applicant): Posttraumatic Stress Disorder (PTSD) is debilitating and common (up to 30% in Vietnam Veterans and 16% in Afghanistan and Iraq Veterans). A significant number of Veterans do not engage in or drop-out from effective trauma-focused therapies due to avoidance from trauma-related memories. Because of this limitation, and because scientific literature suggested that acupuncture might be effective for PTSD symptoms, we developed an acupuncture intervention for PTSD and conducted a clinical trial that showed positive effects. This remains the only high quality trial of acupuncture for PSTD published, because of which the current VA/DoD guidelines for PTSD state that acupuncture is a "B" recommendation (fair evidence, provide service) for PTSD treatment. That civilian study compared acupuncture to an effective therapy (CBT) and a wait-list control, but did not have a placebo control. And, research has shown that Veterans may respond differently to therapies than civilians. More definitive data about the efficacy of acupuncture for PTSD is required in order to recommend it as an "A" evidence-based intervention for PTSD in Veterans. Specifically, it is important to show that acupuncture is better than a placebo control and that it has effects on biological abnormalities of PTSD. The aim of this study is to demonstrate efficacy of acupuncture for PTSD by showing clinical and biological effects that are statistically larger and clinically more important than effects of "sham" acupuncture. Given current knowledge and the need for efficient, ethical and best practices within an experimental design, the primary aim is best accomplished by a randomized controlled trial comparing verum acupuncture (ACU) to placebo minimal needling sham acupuncture (MIN). The goal is to evaluate ACU for a significant positive signal, not to compare ACU to other interventions or to evaluate treatment durability. Acupuncture is delivered in 24 sessions over 12 weeks. The primary hypothesis is that efficacy of ACU for PTSD symptom severity will be large (pre- to post- treatment Cohen's d > 0.8), and significantly better than MIN (between group Cohen's d > 0.30, with 80% probability of detecting a true group difference at p<0.05 (2-sided). The secondary hypothesis is that compared to MIN, ACU will be associated with a significantly larger change from pre- to post-treatment in psychophysiological response (decreased startle by EMG eye blink during fear conditioning procedure). The study design is a two-arm, parallel-group, prospective RCT. The sample frame is Veterans with chronic PTSD with a sample of convenience from those seeking care at the Long Beach VA. Exclusion criteria are meant to keep out individuals with characteristics that are known to be PTSD treatment confounds, associated with non- adherence or negative response to treatment, that may significantly affect biological assessment, or who may be put at risk of harm. The sample size (90) provides adequate power to test hypotheses. Subjects will be allocated to intervention group by computer-generated adaptive randomization. General linear mixed models will be used to evaluate hypothesized effects over time (mid treatment, end of treatment, 1-month follow-up), controlling for baseline severity of symptoms and demographic characteristics (e.g., age, gender) using intent-to-treat modeling. Outcome effect size (Cohen's d) within and between subjects will be calculated. Interaction terms will be included in the models to evaluate treatment fidelity and treatment expectancy as potential moderators. Study results will provide clinicians and policy makers with more information to make decisions about the rational use of acupuncture for PTSD. This is important because acupuncture is being touted for PTSD by many advocates. It has the potential to reach PTSD sufferers who are not willing to engage in trauma-focused psychotherapy, or for whom current therapies are ineffective. The objective of this project is consistent with priority research areas of specific interest to CSR&D including PTSD and complementary medicine, and all participants are Veterans at a VA Hospital.

 描述（由申请人提供）： 创伤后应激障碍（PTSD）令人衰弱且常见（越南退伍军人最多30％，阿富汗和伊拉克退伍军人16％）。由于避免与创伤相关的记忆，许多退伍军人不会从有效的创伤疗法中参与或辍学。由于这一限制，并且由于科学文献表明针灸可能对PTSD症状有效，因此我们开发了针灸干预PTSD，并进行了一项临床试验，显示出积极作用。这仍然是PSTD发布的针灸的唯一高质量试验，因为当前的VA/DOD准则指南指出，针灸是PTSD治疗的“ B”建议（公平证据，提供服务）。这项平民研究将针灸与有效疗法（CBT）和等待名单控制进行了比较，但没有安慰剂控制。而且，研究表明，退伍军人对疗法的反应可能与平民不同。为了将其作为对退伍军人的PTSD的“基于证据的干预措施），需要对PTSD的针灸效率进行更确定的数据。具体来说，重要的是要表明针灸更好 比安慰剂控制对PTSD的生物异常有影响。这项研究的目的是通过显示统计和临床上比“假”针灸的作用更大，在临床上更重要的临床和生物学作用来证明针灸对PTSD的有效性。鉴于当前的知识以及实验设计中有效，道德和最佳实践的需求，主要目的是通过比较Verum针灸（ACU）与安慰剂最小的针刺假手术针灸（Min）的随机对照试验来实现的。目的是评估ACU的明显正信号，而不是将ACU与其他干预措施进行比较或评估治疗耐用性。针灸在12周内在24个会议中进行。主要的假设是，ACU对PTSD症状严重程度的有效性将很大（治疗前Cohen的D> 0.8），并且明显优于最小值（在Cohen组的D> 0.30之间，检测到p <0.05时的真实组差异的80％概率与次要假设相关的较大的PETES。心理生理反应（在恐惧调节过程中，EMG眼睛的眨眼都会减少。可能会影响生物学评估，或者可能会受到损害的风险（90），可以通过计算机生成的适应性随机性来测试假设。性别）使用对象效应的大小（Cohen d），将计算在受试者之间。 忠诚和治疗期望作为潜在的主持人。研究结果将为临床医生和政策制定者提供更多信息，以决定针灸对PTSD的合理使用。这很重要，因为许多倡导者正在为PTSD吹捧针灸。它有可能吸引不愿从事以创伤为中心的心理疗法或目前疗法无效的PTSD患者。该项目的目的是与CSR＆D（包括PTSD和补充医学）特别感兴趣的优先研究领域保持一致，所有参与者都是VA医院的退伍军人。