A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTS

正念冥想疗法治疗 PTS 的多中心随机对照试验

• 批准号: 8453248
• 负责人: James Douglas Bremner
• 金额: --
• 依托单位: TUSCALOOSA VETERANS AFFAIRS MEDICAL CTR
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8453248
• 关键词: Adherence; Afghanistan; Alabama; Antidepressive Agents; Anxiety; Awareness; Biological Markers; Chronic; Clinical; Clinical Trials; Complementary and alternative medicine; Conduct Clinical Trials; Development; Disease remission; Ensure; Evidence based practice; Evidence based treatment; Freedom; Functional disorder; Gold; Group Therapy; Hour; Intervention; Iraq; Knowledge; Light; Massachusetts; Mediation; Meditation; Mental Depression; Mental Processes; Mental disorders; Methods; Minority; Mission; Monitor; Outcome; Pain; Panic; Participant; Patients; Pilot Projects; Population; Post-Traumatic Stress Disorders; Procedures; Psychotherapy; Randomized; Randomized Controlled Trials; Recruitment Activity; Request for Applications; Research Personnel; Research Priority; Rural; Safety; Single-Blind Study; Sleeplessness; Stress; Symptoms; Therapeutic Effect; Thinking; Training; Trauma; Treatment outcome; Universities; Veterans; War; base; blind; chronic pain; clinical care; clinical research site; clinically relevant; coping; effective therapy; experience; improved; medical schools; mindfulness; mindfulness meditation; mindfulness-based stress reduction; operation; preference; programs; prospective; response; satisfaction; socioeconomics; standard measure; treatment effect; young man; young woman

DESCRIPTION (provided by applicant): A Multisite Randomized Controlled Trial of Mindfulness Mediation Therapy for PTSD Background: Currently, veterans with posttraumatic stress disorder (PTSD) are typically treated with antidepressants which have limited efficacy and yield extremely low remission rates. New and improved treatments are sorely needed, especially in light of the inadequate evidence to support the efficacy of most pharmacologic and most psychotherapy treatments for PTSD. Complementary and Alternative Medicine practices, such as meditation, may fill this void. Several other illnesses often found in association with PTSD, such as chronic pain, anxiety, and depression, have shown positive response to meditation, specifically Mindfulness Based Stress Reduction (MBSR). MBSR is manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes. MBSR is a well tolerated, already well disseminated. MBSR has been shown to be effective in reducing conditions that are commonly associated with PTSD, including pain, depression, anxiety and panic, and insomnia. Methods: We propose a prospective, randomized (1:1), controlled multisite study of MBSR in 180 veterans with PTSD. We will compare the clinical outcomes of MBSR to a credible group therapy control condition called Present Centered Group Therapy (PCGT). We will to evaluate the efficacy of MBSR in the treatment of PTSD, as defined by the Clinician Administered PTSD Scale (CAPS), a gold standard measure that is clinically relevant to PTSD. The CAPS will be rated by a trained assessor who is blind to the whether or not the participant receives the MBSR or PCGT intervention. Secondarily, we will evaluate the effects of MBSR on mindfulness, depression, PTSD symptom clusters, rates of response and evaluate the safety and tolerability of MBRS. We will also explore the subjects' acceptance of and satisfaction with MBSR, whether or not the subjects' treatment preference influences outcome; the stress-immunological-biomarkers as they relate to treatment outcome; and the durability of therapeutic effects of MBSR in the treatment of PTSD. Significance: Operations Enduring Freedom, Iraqi Freedom, and New Dawn have brought in large numbers of young men and women with war-related trauma and PTSD and have renewed our sense of mission. PTSD is a chronic and costly illness and treating PTSD is a VHA priority. Clinical trials of psychotherapeutic treatments for PTSD, particularly MBSR, are needed to fill the gap in knowledge and expand the evidence based treatment alternatives for veterans with PTSD.

描述（由申请人提供）： 正念介导疗法治疗创伤后应激障碍的多中心随机对照试验背景：目前，患有创伤后应激障碍（PTSD）的退伍军人通常使用疗效有限且缓解率极低的抗抑郁药治疗。新的和改进的治疗方法是迫切需要的，特别是考虑到没有足够的证据支持大多数药物和大多数心理治疗对PTSD的疗效。补充和替代医学实践，例如冥想，可以填补这一空白。其他几种经常与PTSD相关的疾病，如慢性疼痛，焦虑和抑郁，对冥想，特别是基于正念的减压（MBSR）表现出积极的反应。正念减压疗法是一种手动化的课程，包括每周8节课和一次6小时的静修课，该课程基于一个系统的程序，旨在培养对可感知心理过程的瞬间体验的增强的非反应性意识。正念减压疗法是一种耐受性良好，已经广泛传播的药物。正念减压疗法已被证明能有效地减少通常与创伤后应激障碍有关的症状，包括疼痛、抑郁、焦虑和恐慌以及失眠。方法：我们提出了一个前瞻性的，随机（1：1），对照多站点研究的正念减压在180名退伍军人与创伤后应激障碍。我们将比较正念减压疗法的临床结果与一种称为以现在为中心的团体治疗（PCGT）的可信的团体治疗控制条件。我们将评估正念减压疗法在治疗PTSD中的疗效，PTSD由临床医生管理的PTSD量表（CAPS）定义，CAPS是临床上与PTSD相关的金标准测量。CAPS将由一名经过培训的评估人员进行评估，该评估人员不知道受试者是否接受了MBSR或PCGT干预。其次，我们将评估MBSR对正念，抑郁，PTSD症状群，反应率的影响，并评估MBRS的安全性和耐受性。我们还将探讨受试者对正念减压疗法的接受程度和满意度，受试者的治疗偏好是否影响结果;与治疗结果相关的应激免疫学生物标志物;以及正念减压疗法治疗PTSD的疗效持久性。重要性：“持久自由行动”、“伊拉克自由行动”和“新黎明行动”带来了大量患有战争创伤和创伤后应激障碍的年轻男女，并使我们重新燃起了使命感。创伤后应激障碍是一种慢性和昂贵的疾病，治疗创伤后应激障碍是VHA的优先事项。心理治疗的临床试验 对于创伤后应激障碍，特别是正念减压疗法，需要填补知识上的差距，并扩大基于证据的治疗方案，为退伍军人与创伤后应激障碍。