Applying Mindfulness-Based Cognitive Therapy to Treatment-Resistant Depression

描述（由申请人提供）：重度抑郁症（MDD）是世界上导致残疾的主要原因。难治性抑郁症（Treatment-Resistant Depression，TRD）是导致大多数MDD残疾的原因。值得注意的是，50%的MDD患者在两次充分的抗抑郁药物试验后都无法缓解，从而遭受TRD。目前TRD的药物和心理治疗策略的有效性有限，因此需要新的技术。这项资助是一项针对TRD人群的基于正念的认知疗法（MBCT）的随机对照试验。MBCT是一种新技术，以前已被发现有效地预防复发的个人在完全缓解。MBCT是一种以小组为基础的为期8周的干预，使用正念冥想作为其核心治疗成分。它教导人们对抑郁的想法和感受有不同的关系。三项关于MBCT的开放性试验，两项比较MBCT与治疗性治疗（TAU）的试点研究，以及我们的试点数据，发现MBCT对TRD有效。这项研究将使用一个积极的控制条件，健康增强计划（HEP），这是专门开发的，作为一个可靠的控制正念干预。我们计划确定124例MDD患者，这些患者使用抗抑郁药治疗历史表软件记录了两次或两次以上充分的抗抑郁药试验失败。然后我们将患者随机分为两组：MBCT+TAU或HEP+TAU。预计将有100名患者完成治疗。入组研究的所有124名患者将在8周干预后的6个月和12个月接受随访评估。本研究的具体目的是确定MBCT在减少TRD成人抑郁症中的急性疗效。该研究将使用汉密尔顿抑郁量表在8周的时间内测试MBCT+TAU在减少抑郁症状和提高缓解率和应答率方面比HEP+TAU更有效的假设。我们还将进行一系列次要假设和分析，以评估MBCT+TAU在减少残疾和改善生活质量方面是否比HEP+TAU更有效。此外，我们还将评估MBCT疗效的潜在介质：增强正念，减少反刍，减少经验回避。虽然这是一项MBCT治疗TRD的急性治疗试验，但我们也将评估8周治疗的有益效果是否在6个月和12个月时持续存在。这项研究的结果将具有明确的公共卫生意义，因为MBCT可以证明是TRD患者的有效治疗方法，减少TRD常见的痛苦，残疾和医疗并发症。公共卫生相关性：重度抑郁症是世界上最普遍的精神健康问题。本研究是一项随机对照试验，旨在对难治性抑郁症（TRD）人群进行基于正念的认知疗法（MBCT）的新适应。由于TRD影响50%的抗抑郁药治疗的个体，MBCT具有显着的潜力，以帮助减少痛苦，残疾和医疗并发症，往往伴随着这种疾病。

DESCRIPTION (provided by applicant): Major depressive disorder (MDD) is a leading cause of disability in the world. Treatment-Resistant Depression (TRD) causes the majority of MDD's disability. Strikingly, 50% of individuals with MDD will fail to remit with two adequate trials of antidepressant medications, thus suffering TRD. Current pharmacological and psychotherapeutic treatment strategies for TRD are limited in effectiveness so new techniques are needed. This grant is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) for the TRD population. MBCT is a new technique that has previously been found effective for prevention of relapse in individuals in complete remission. MBCT is a group-based, 8-week intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. Three open trials of MBCT, two pilot studies comparing MBCT to Treatment-as-Usual (TAU), and our pilot data, have found MBCT to be effective for TRD. This study will use an active control condition, the Health- Enhancement Program (HEP), which was specifically developed to serve as a credible control for mindfulness interventions. We plan to identify 124 patients with MDD who have failed two or more adequate antidepressant trials documented with the Antidepressant Treatment History Form software. We will then randomly assign patients to two groups: MBCT+TAU or HEP+TAU. We anticipate 100 patients will complete treatment. All 124 patients who enroll in the study will undergo follow-up assessments at 6 and 12 months following the 8 week intervention. The specific aim of this study is to determine the acute efficacy of MBCT in reducing depression in adults with TRD. The study will test the hypotheses that MBCT+TAU is more effective than HEP+TAU in reducing depressive symptoms and enhancing remission and response rates using the Hamilton Rating Scale for Depression over a period of 8 weeks. We will also conduct a series of secondary hypotheses and analyses to evaluate if MBCT+TAU is more effective than HEP+TAU in reducing disability and improving quality of life. In addition we will also evaluate potential mediators of MBCT efficacy: enhanced mindfulness, decreased rumination, and decreased experiential avoidance. Although this is an acute treatment trial of MBCT in TRD, we will also evaluate whether beneficial effects of 8 weeks of treatment persist at 6 and 12 months. Findings from this study would have clear public health significance because MBCT could prove to be an effective treatment for TRD patients, reducing the suffering, disability, and medical comorbidity common in TRD. PUBLIC HEALTH RELEVANCE: Major depressive disorder is the most prevalent mental health problem in the world. This study is a randomized, controlled trial of a new adaptation of Mindfulness-Based Cognitive Therapy (MBCT), to the Treatment-Resistant Depression (TRD) population. Because TRD affects 50% of individuals treated with antidepressants, MBCT has significant potential to help reduce the suffering, disability, and medical comorbidity that often accompanies this disorder.