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（TRD）是MDD致残的主要原因。引人注目的是，50%的重度抑郁症患者无法通过两次充分的抗抑郁药物试验来缓解症状，因此患上了抑郁症。目前的药物和心理治疗策略对TRD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，以前发现对完全缓解的个体预防复发有效。MBCT是一种以小组为基础、为期8周的干预，以正念冥想为核心治疗成分。它教会人们与抑郁的想法和感受建立不同的关系。三个MBCT的公开试验，两个比较MBCT与常规治疗（TAU）的试点研究，以及我们的试点数据，都发现MBCT对TRD有效。本研究将使用主动控制条件，即健康增强计划（HEP），这是专门为正念干预开发的可靠控制。我们计划确定124名MDD患者，他们在抗抑郁药物治疗历史表格软件中记录了两次或两次以上的抗抑郁药物试验失败。然后我们将患者随机分为两组：MBCT+TAU或HEP+TAU。我们预计将有100名患者完成治疗。所有124名参加研究的患者将在8周干预后的6个月和12个月进行随访评估。本研究的具体目的是确定MBCT在减轻成人TRD患者抑郁方面的急性疗效。本研究将在8周的时间内使用汉密尔顿抑郁量表测试MBCT+TAU比HEP+TAU在减轻抑郁症状和提高缓解和反应率方面更有效的假设。我们还将进行一系列次要假设和分析，以评估MBCT+TAU是否比HEP+TAU更有效地减少残疾和改善生活质量。此外，我们还将评估MBCT有效性的潜在中介：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持续到6个月和12个月。这项研究的发现将具有明确的公共卫生意义，因为MBCT可以证明是一种有效的治疗TRD患者的方法，减少TRD患者的痛苦、残疾和常见的医疗合并症。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。本研究是一项基于正念的认知疗法（MBCT）对难治性抑郁症（TRD）人群的新适应的随机对照试验。由于接受抗抑郁药物治疗的患者中有50%患有TRD，因此MBCT在帮助减少这种疾病的痛苦、残疾和合并症方面具有重要的潜力。

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.