Optimizing an integrated whole-body hyperthermia and behavioral intervention for major depressive disorder

项目摘要/摘要： 严重抑郁障碍困扰着全世界3亿多人，是导致因残疾而失去生命的主要原因。目前的治疗方法在疗效方面有很大的局限性，就药物治疗而言，还有很大的副作用。因此，迫切需要更多有效、耐受性良好的治疗方法。其中一种潜在的治疗方法是全身热疗(WBH)。我们推测，WBH与认知行为疗法(CBT)结合可能特别有效，认知行为疗法是一种公认的抑郁症治疗方法。这种组合可能会增加抑郁症患者的突然获益(抑郁症症状的快速改善)。突如其来的增长预示着抑郁症的持久改善。在两个患有抑郁症的成年人的小样本中，一次WBH治疗导致抑郁症患者的突然增加和积极情绪的急剧增加，这与认知灵活性的增加有关。尽管试点研究的初步数据前景看好，但需要进行严格、精心设计的临床试验，以制定包括WBH在内的抑郁症治疗建议。特别是，研究人员还没有调查心身结合(CBT)和身体(WBH)干预作为抑郁症潜在综合治疗方法的潜力。在这项提案中，我们的目标是为此类试验奠定基础。在AIM 1(阶段1)中，我们将进行单臂试验(N=16)，以改进和优化将WBH(4个双周疗程)与CBT(8个每周疗程)整合的程序。我们将在完成第一波n=8名参与者的所有程序后，在启动第二波n=8名参与者之前，反复完善程序。在第一阶段结束时，我们将完成第二阶段使用的联合干预组件的最终手册。在AIM 2(第二阶段)中，我们将进行一项可行性试点试验(N=30)，在该试验中，我们随机将参与者分为活动WBH(4个双周课程)和CBT(8个每周课程)干预或假WBH(4个双周课程)CBT(8个每周课程)。在前半部分注册完成后(n=15)，我们将使用参与者和工作人员的反馈来改进剩余注册的程序(n=15；总共N=30)。这项可行性试点试验将测试招募和随机程序，为重度抑郁症参与者的多中心临床疗效试验做准备。这项工作对改善抑郁症的治疗和促进对心身综合疗法在情绪障碍中的作用的理解具有重要的前景。

Project Summary/Abstract: Major Depressive Disorder afflicts more than 300 million people worldwide and is the leading cause of life years lost to disability. Current treatments have important limitations in efficacy and, in the case of medication, substantial side-effects. There is thus a compelling need for additional effective, well-tolerated treatments. One such potential treatment is whole-body hyperthermia (WBH). We hypothesize that WBH may be particularly effective in combination with cognitive behavioral therapy (CBT), an established treatment for depression. This combination may increase sudden gains (rapid improvements in depression symptoms) in individuals with depression. Sudden gains predict durable improvements in depression. In two small samples of adults with depression, a single session of WBH precipitated sudden gains and acute increases in positive affect, which are associated with increases in cognitive flexibility, in individuals with depression. Despite promising initial data from pilot studies, rigorous, well-designed clinical trials are required in order to develop treatment recommendations for depression that include WBH. In particular, researchers have not investigated the potential of an integrated mind (CBT) and body (WBH) intervention as a potential integrative treatment approach for depression. We aim to lay the groundwork for such trials in this proposal. In Aim 1 (Phase 1), we will conduct a single-arm trial (N=16) to refine and optimize procedures for integrating WBH (4 bi-weekly sessions) with CBT (8 weekly sessions). We will iteratively refine procedures after completing all procedures for the first wave of n=8 participants before initiating the second wave of n=8 participants. At the end of Phase 1 we will complete a final manual for the combined intervention components for use in Phase 2. In Aim 2 (Phase 2) we will conduct a feasibility pilot trial (N=30) in which we randomize participants to receive active WBH (4 bi-weekly sessions) and CBT (8 weekly sessions) intervention or sham WBH (4 bi-weekly sessions) CBT only (8 weekly sessions). After the first half of enrollment is complete (n=15), we will use participant and staff feedback to refine procedures for the remaining enrollment (n=15; N=30 total). This feasibility pilot trial will test recruitment and randomization procedures in preparation for a multicenter clinical efficacy trial for participants with major depression. This work holds important promise to improve treatment of depression and advance understanding of the role of integrated mind-body therapies for mood disorders.