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: 10303773
• 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/10303773
• 关键词: Acute; Address; Adult; Affect; Behavior Therapy; Biological; Body Temperature; Brain; Clinical; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Coronary Arteriosclerosis; Data; Depressive disorder; Disease remission; Double-Blind Method; Enrollment; Feedback; Frequencies; Health; Heating; Hyperthermia; Impairment; Individual; Induced Hyperthermia; Integrative Therapy; Intervention; Interview; Major Depressive Disorder; Manuals; Mental Depression; Mind; Mind-Body Intervention; Modality; Mood Disorders; Moods; Outcome; Participant; Pathway interactions; Patients; Pharmaceutical Preparations; Pharmacology; Phase; Pilot Projects; Preparation; Procedures; Protocols documentation; Psychotherapy; Quality of life; Questionnaires; Randomized; Recommendation; Research; Research Personnel; Rodent; Role; Sampling; Sauna; Skin; Sweat Lodge; Symptoms; Testing; Therapeutic Intervention; Work; World Health Organization; Yoga; acceptability and feasibility; arm; base; body-mind; burden of illness; cognitive benefits; comparison group; depressive symptoms; disability; efficacy clinical trial; efficacy trial; evidence base; feasibility testing; flexibility; follow-up; healing; improved; pilot trial; recruit; safety assessment; side effect; tool; 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 (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.

项目摘要/摘要 主要的抑郁症折磨于全球超过3亿人，是生命的主要原因 多年因残疾而失去。当前的治疗在功效中有重要的局限性，在药物治疗的情况下， 实质性副作用。因此，需要进行其他有效，耐受良好的治疗方法。一 这种潜在的治疗是全身高温（WBH）。我们假设WBH可能特别是 有效与认知行为疗法（CBT）结合使用，这是一种已建立的抑郁疗法。这 组合可能会增加患有 沮丧。突然的收益预测抑郁症的持久改善。在两个成年人的小样本中 抑郁症，一场WBH促进了突然的收益和急性增加的积极影响，这是 与抑郁症患者的认知灵活性增加有关。尽管有希望的最初 来自试点研究的数据，需要进行严格，精心设计的临床试验才能开发治疗 包括WBH在内的抑郁症的建议。特别是，研究人员尚未调查 综合思维（CBT）和身体（WBH）干预的潜力作为潜在的综合治疗 抑郁症的方法。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 将进行单臂试验（n = 16），以完善和优化整合WBH的程序（每周8个 会议）与CBT（每周8个会议）。完成所有程序后，我们将迭代完善程序 对于n = 8参与者的第一波，在启动第二波n = 8参与者之前。在阶段结束时 1我们将完成一份最终手册，用于在第2阶段使用的合并干预组件。在AIM 2 （第2阶段）我们将进行可行性试验试验（n = 30），我们将参与者随机接收 综合WBH（每周8周）和CBT（8周一次）干预或仅独立CBT（8个 每周会议）。在入学的上半年完成（n = 15）之后，我们将使用参与者和员工反馈 为了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 招聘和随机程序为参与者准备多中心临床疗效试验 严重抑郁症。这项工作具有改善抑郁症治疗和进步的重要承诺 了解综合思维疗法对情绪障碍的作用。