A trial of Loving-Kindness Meditation and Cognitive Processing Therapy for PTSD

描述（由申请人提供）： 背景：创伤后应激障碍（PTSD）是一个世界性的问题，是创伤的常见后果。PTSD通常与抑郁症合并。尽管有药物和心理治疗，许多PTSD患者仍会出现持续的症状。退伍军人经常使用补充和替代医学（CAM）干预措施，以加强他们的传统护理，并解决他们的社会和精神需求。拟议的对照随机试验将评估一种新的CAM干预，慈爱冥想（LKM），是否在减少PTSD和抑郁症状方面不明显劣于另一种基于组的PTSD治疗，认知加工疗法（仅认知版本; CPT-C）。在我们实验室完成的一项针对患有PTSD的男性和女性退伍军人的LKM开放试验的可喜结果表明，LKM是可行和安全的，并且与PTSD症状和抑郁症的显着改善以及自我同情的增强有关。在拟议的项目中，170名患有PTSD的退伍军人将被随机分配到LKM或CPT-C组。将在基线以及12周干预结束时和3个月和6个月后进行综合评估。在治疗期间，每周评估PTSD症状、抑郁、创伤后适应不良认知和自我同情，以评估变化的时间性并评估结局的介导因素。具体目标：目标1：评估LKM在减少目前患有PTSD的退伍军人的PTSD症状方面是否不劣于CPT-C。目的2：评估LKM和CPT-C在减少目前患有PTSD的退伍军人抑郁症状方面的非劣效性。探索性目的：评估对LKM和CPT反应的潜在介质，以提供有关它们是否与每种干预措施所概念化的与PTSD和抑郁症改善相关的变化机制一致的初步信息。设计：一项比较LKM与CPT-C的随机对照非劣效性试验。参与者：170名患有PTSD的男性和女性退伍军人。干预：12周基于组的LKM或CPT-C。假设和分析：随机分配到LKM组的退伍军人将报告PTSD和抑郁症状严重程度的平均降低，这些降低并不比CPT-C更严重。我们进一步假设，减少创伤后适应不良的信念将更强烈地介导PTSD和抑郁症状的改善那些分配到CPT-C比那些分配到LKM。含义：如果LKM的结局改善不劣于CPT-C，则本试验的结果将支持将LKM作为患有PTSD的退伍军人的额外基于组的治疗。

DESCRIPTION (provided by applicant): Background: Posttraumatic stress disorder (PTSD) is a worldwide problem that is a common consequence of trauma. PTSD is often comorbid with depression. Despite the availability of medications and psychotherapy, many persons with PTSD experience persistent symptoms. Veterans frequently use Complementary and Alternative Medicine (CAM) interventions to augment their traditional care and to address their social and spiritual needs. The proposed controlled randomized trial will assess whether a novel CAM intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only version; CPT-C) for reductions in PTSD and depressive symptoms. Promising results from an open trial of LKM completed in our laboratory with male and female Veterans with PTSD suggest that LKM is feasible and safe Veterans with PTSD, and is associated with significant improvements in PTSD symptoms and depression, as well as enhanced self-compassion. In the proposed project 170 Veterans with PTSD will be randomized to LKM or CPT-C. Comprehensive assessments will be performed at baseline as well as at the end of the 12-week interventions and 3 and 6 months later. PTSD symptoms, depression, posttraumatic maladaptive cognitions and self-compassion will be assessed weekly during the treatment phase to assess temporality of change and to assess mediators of outcomes. Specific Aims: Aim 1: Evaluate if LKM is non-inferior to CPT-C in producing reductions in PTSD symptoms among Veterans with current PTSD. Aim 2: Evaluate the non-inferiority of LKM and CPT-C in producing reductions in depressive symptoms among Veterans with current PTSD. Exploratory Aim: Evaluate potential mediators of response to LKM and to CPT to provide preliminary information regarding whether they are consistent with the mechanisms of change conceptualized by each intervention to be associated with improvement in PTSD and depression. Design: A randomized controlled non-inferiority trial comparing LKM to CPT-C. Participants: 170 male and female Veterans with current PTSD. Intervention: 12-week group-based LKM or CPT-C. Hypotheses and Analyses: Veterans randomized to LKM will report mean reductions in PTSD and depressive symptom severity that are not meaningfully worse than CPT-C. We further hypothesize that reductions in posttraumatic maladaptive beliefs will more strongly mediate PTSD and depressive symptom improvement for those assigned to CPT-C than those assigned to LKM. Implications: If improvement in outcomes for LKM are non-inferior to CPT-C, the findings of this trial would support offering LKM as an additional group-based treatment for Veterans with PTSD.