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球3亿多人，是生活的主要原因 因伤残而失去的年数。目前的治疗方法在疗效上有很大的局限性，就药物治疗而言， 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。一 这种潜在的治疗方法是全身热疗(WBH)。我们假设WBH可能特别 与认知行为疗法(CBT)相结合有效，认知行为疗法是一种公认的抑郁症治疗方法。这 联合应用可能会增加患有以下疾病的患者的突然获益(抑郁症状的快速改善) 抑郁症。突如其来的增长预示着抑郁症的持久改善。在两个小样本的成人中， 抑郁，一次WBH促使突然增加和积极情绪的急剧增加，这 在抑郁症患者中，与认知灵活性的增加有关。尽管最初的前景看好 为了开发治疗方法，需要来自先导性研究的数据，需要严格的、设计良好的临床试验 治疗抑郁症的建议包括腰围过高。特别是，研究人员还没有调查 心身综合干预作为一种潜在的综合治疗方法的潜力 治疗抑郁症的方法。在这项提案中，我们的目标是为此类试验奠定基础。在目标1(阶段1)中，我们 将进行单臂试验(N=16)，以细化和优化整合WBH的程序(每周8次 会议)与CBT(每周8次会议)。我们将在完成所有程序后迭代完善程序 对于第一波n=8个参与者，在启动第二波n=8个参与者之前。在阶段结束时 1我们将完成在第二阶段使用的综合干预组件的最终手册。 (阶段2)我们将进行可行性试点试验(N=30)，在该试验中，我们随机选择参与者，让他们接受 综合WBH(每周8次)和CBT(每周8次)干预或仅独立CBT(8次 每周会议)。在前半部分注册完成后(n=15)，我们将使用参与者和员工的反馈 完善剩余招生程序(n=15；总共N=30)。这项可行性中试将测试 为参与者的多中心临床疗效试验做准备的招募和随机程序 患有严重的抑郁症。这项工作对改善抑郁症的治疗和进步具有重要的前景 理解心身综合疗法对情绪障碍的作用。

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 (8 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 an integrated WBH (8 weekly sessions) and CBT (8 weekly sessions) intervention or standalone 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.