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。创伤后应激障碍通常与抑郁症并存。尽管有药物和心理治疗，许多创伤后应激障碍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)干预措施来加强他们的传统护理，并满足他们的社会和精神需求。这项拟议的随机对照试验将评估一种新的CAM干预措施--爱心冥想(LKM)在减少创伤后应激障碍和抑郁症状方面是否显著低于另一组基于创伤后应激障碍的治疗方法-认知处理疗法(仅限认知版本；CPT-C)。在我们实验室对患有创伤后应激障碍的男性和女性退伍军人进行的LKM公开试验结果令人振奋，表明LKM是可行和安全的，与创伤后应激障碍症状和抑郁的显著改善以及增强的自我同情有关。在拟议的项目中，170名患有创伤后应激障碍的退伍军人将被随机分配到LKM或CPT-C。将在基线、12周干预结束时以及3个月和6个月后进行全面评估。创伤后应激障碍症状、抑郁、创伤后适应不良认知和自我同情将在治疗阶段每周进行评估，以评估变化的暂时性和评估结果的中介因素。具体目标：目标1：评估LKM在减少患有当前创伤后应激障碍的退伍军人的创伤后应激障碍症状方面是否不逊于CPT-C。目的2：评估LKM和CPT-C在减轻目前患有创伤后应激障碍的退伍军人抑郁症状方面的非劣势。探索性目的：评估LKM和CPT的潜在反应介质，以提供初步信息，说明它们是否与每个干预措施构想的与改善创伤后应激障碍和抑郁相关的变化机制一致。设计：一项比较LKM和CPT-C的随机对照非劣势试验。研究对象：170名患有创伤后应激障碍的退伍军人。干预：为期12周的小组LKM或CPT-C。假设和分析：被随机分配到LKM的退伍军人将报告创伤后应激障碍和抑郁症状严重程度的平均下降，但并不显著低于CPT-C。我们进一步假设，创伤后适应不良信念的减少将比那些分配给LKM的人更强烈地中介那些被分配到CPT-C的人的创伤后应激障碍和抑郁症状的改善。意义：如果LKM的结果改善不逊于CPT-C，这项试验的结果将支持将LKM作为退伍军人创伤后应激障碍的另一种基于群体的治疗。

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.