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

优化重度抑郁症的综合全身热疗和行为干预

• 批准号: 10640897
• 负责人: Frederick M Hecht
• 金额: $ 24.23万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10640897
• 关键词: Acute; Adult; Affect; Behavior Therapy; Body Temperature; Clinical Trials Design; Cognitive; Cognitive Therapy; Data; Enrollment; Feedback; Heating; Hyperthermia; Individual; Integrative Therapy; Intervention; Interview; Major Depressive Disorder; Manuals; Mental Depression; Mind-Body Intervention; Mood Disorders; Participant; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Preparation; Procedures; Protocols documentation; Psychotherapy; Questionnaires; Randomized; Recommendation; Research Personnel; Role; Sampling; Sauna; Site; Sweat Lodge; Temperature; Testing; Therapeutic Intervention; Work; acceptability and feasibility; arm; burden of illness; depressive symptoms; disability; efficacy clinical trial; efficacy trial; evidence base; feasibility testing; flexibility; improved; mind/body; pilot trial; recruit; side effect; treatment arm

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.

项目摘要/摘要： 主要的抑郁症折磨于全球超过3亿人，是残疾人丧生的主要原因。当前的治疗方法在疗效方面具有重要的局限性，并且在药物治疗的情况下是实质性的副作用。因此，需要进行其他有效，耐受良好的治疗方法。一种潜在的治疗方法是全身高温（WBH）。我们假设WBH可能与认知行为疗法（CBT）（一种已建立的抑郁症治疗方法）结合使用。这种组合可能会增加抑郁症患者的突然增长（抑郁症状的快速改善）。突然的收益预测抑郁症的持久改善。在两个抑郁症的成年人的小样本中，一段WBH会导致突然的增长和急性增加，这与抑郁症患者的认知灵活性增加有关。尽管有希望来自试点研究的初始数据，但仍需要进行严格，精心设计的临床试验，以制定包括WBH在内的抑郁症的治疗建议。特别是，研究人员没有研究综合思想（CBT）和身体（WBH）干预的潜力，作为抑郁症的潜在综合治疗方法。我们的目标是在此提案中为此类试验奠定基础。在AIM 1（第1阶段）中，我们将进行一项单臂试验（n = 16），以完善和优化将WBH（4个每两周每周一次）与CBT（8周每周一次）集成的程序。在启动第二波n = 8参与者之前，我们将在完成第一波n = 8参与者的所有过程后进行迭代完善过程。在第1阶段结束时，我们将完成一份最终手册，用于在第2阶段使用的组合干预组件。在AIM 2（第2阶段）中，我们将进行可行性试验试验（n = 30），在该试验中，我们随机将参与者随机接收活跃的WBH（4周周期）和CBT（8周每周）（8周一次）干预或仅3个周期的Sessions sesseions（4个周期）。在入学的上半年完成（n = 15）之后，我们将使用参与者和员工的反馈来完善其余注册的程序（n = 15; n = 30）。这项可行性试验试验将测试招募和随机程序，为重度抑郁症的参与者进行多中心临床疗效试验做准备。这项工作具有改善抑郁症治疗并提高对情绪障碍综合思维疗法作用的理解的重要承诺。