Applying Mindfulness-Based Cognitive Therapy to Treatment-Resistant Depression

将基于正念的认知疗法应用于难治性抑郁症

基本信息

批准号：
7763921
负责人：
STUART JAMES EISENDRATH
金额：
$ 60万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-03-01 至 2013-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7763921
关键词：
Acute Adult Affect Antidepressive Agents Beck depression inventory Clinical Clinical Trials Cognitive Comorbidity Computer software Data Disease Disease remission Educational process of instructing Effectiveness Elements Enrollment Equipment and supply inventories Feeling Grant Hamilton Rating Scale for Depression Health Health Surveys In complete remission Individual Intervention Kentucky Length Major Depressive Disorder Mediating Mediator of activation protein Medical Mental Depression Mental Health Modality NIH Program Announcements National Center for Complementary and Alternative Medicine Outcome Measure Patients Pharmaceutical Preparations Pilot Projects Population Public Health Quality of life Questionnaires Randomized Randomized Controlled Clinical Trials Randomized Controlled Trials Recording of previous events Relapse Research Resistance SF-12 Series Severity of illness Social Adjustment Techniques Testing Theoretical Studies Therapeutic Therapeutic Effect Thinking Treatment Efficacy Work active control base depressive symptoms design disability disorder later incidence prevention effective therapy efficacy testing follow up assessment functional status impression improved intervention program mindfulness mindfulness based cognitive therapy mindfulness meditation prevent programs public health relevance response satisfaction secondary outcome skills treatment as usual treatment strategy treatment trial

项目摘要

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.

描述（由申请人提供）：重度抑郁症（MDD）是世界残疾的主要原因。耐治疗抑郁（TRD）导致大多数MDD残疾。令人惊讶的是，有50％的MDD患者将无法通过两项适当的抗抑郁药试验来汇入，因此患有TRD。 TRD的当前药理和心理治疗策略的有效性有限，因此需要新技术。该赠款是针对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，以前已被发现有效预防完全缓解的个体复发。 MBCT是一种基于小组的8周干预措施，使用正念冥想作为其核心治疗成分。它教会人们与抑郁思想和感情有不同的关系。 MBCT进行了三项开放试验，两项将MBCT与治疗方式（TAU）进行比较的试验研究以及我们的试点数据，发现MBCT对TRD有效。这项研究将使用主动控制条件，即健康增强计划（HEP），该计划是专门为正念干预的可靠控制而开发的。我们计划确定124例MDD患者，他们未通过抗抑郁药治疗史形式的软件进行了两次或更多适当的抗抑郁试验。然后，我们将随机将患者分配给两组：MBCT+TAU或HEP+TAU。我们预计100名患者将完成治疗。参加研究的所有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。这项研究的具体目的是确定MBCT在减少TRD抑郁症方面的急性功效。该研究将检验以下假设：MBCT+TAU在减少抑郁症状，并在8周内使用汉密尔顿评级量表来减轻抑郁症状，并提高缓解率和缓解率。我们还将进行一系列次要假设和分析，以评估MBCT+TAU是否在降低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功效的潜在介体：正念增强，反省和体验降低。尽管这是MBCT在TRD中的急性治疗试验，但我们还将评估8周治疗的有益影响是否持续到6个月和12个月。这项研究的发现将具有明显的公共健康意义，因为MBCT可能被证明是TRD患者的有效治疗方法，从而减少了TRD中常见的痛苦，残疾和医疗合并症。公共卫生相关性：重度抑郁症是世界上最普遍的心理健康问题。这项研究是对基于正念的认知疗法（MBCT）的新适应对治疗耐药性抑郁症（TRD）人群的随机对照试验。由于TRD会影响50％的用抗抑郁药治疗的人，因此MBCT具有巨大的潜力，可以帮助减少这种疾病伴随的苦难，残疾和医疗合并症。