Applying Mindfulness-Based Cognitive Therapy to Treatment-Resistant Depression

描述(由申请人提供)：严重抑郁障碍(MDD)是世界上导致残疾的主要原因。难治性抑郁症(TRD)是导致MDD残疾的主要原因。令人惊讶的是，50%的MDD患者将无法缓解两次足够的抗抑郁药物试验，从而患上TRD。目前治疗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，此前已被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的、为期8周的干预措施，使用正念冥想作为其核心治疗成分。它教会人们对抑郁的想法和感觉有一种不同的关系。MBCT的三项公开试验，两项将MBCT与常规治疗(TAU)进行比较的试点研究，以及我们的试点数据，都发现MBCT对TRD有效。这项研究将使用一种积极的控制条件，健康促进计划(HEP)，这是专门开发的，作为正念干预的可信控制。我们计划确定124名MDD患者，他们没有通过抗抑郁药物治疗历史表格软件记录的两次或两次以上足够的抗抑郁药物试验。然后我们将患者随机分为两组：MBCT+TAU组或HEP+TAU组。我们预计将有100名患者完成治疗。所有124名登记参加这项研究的患者将在干预8周后的6个月和12个月接受随访评估。这项研究的具体目的是确定MBCT在减少成人TRD患者抑郁方面的急性疗效。这项研究将使用汉密尔顿抑郁症评定量表在8周的时间内检验MBCT+TAU在缓解抑郁症状和提高缓解和应答率方面比HEP+TAU更有效的假设。我们还将进行一系列次级假设和分析，以评估MBCT+TAU在减少残疾和提高生活质量方面是否比HEP+TAU更有效。此外，我们还将评估MBCT疗效的潜在中介因素：增强正念、减少沉思和减少经验回避。虽然这是一项MBCT在TRD中的急性治疗试验，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。这项研究的结果将具有明显的公共卫生意义，因为MBCT可能被证明是一种有效的治疗TRD患者的方法，减少TRD中常见的痛苦、残疾和医学合并症。公共卫生相关性：严重抑郁障碍是世界上最普遍的精神健康问题。这项研究是一项新的基于正念的认知疗法(MBCT)适应难治性抑郁症(TRD)人群的随机对照试验。由于TRD影响50%接受抗抑郁药物治疗的患者，MBCT具有显著的潜力，有助于减少这种疾病经常伴随的痛苦、残疾和医学共病。

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.