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: 10462652
• 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/10462652
• 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; Persons; 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; burden of illness; cognitive benefits; comparison group; depressive symptoms; disability; efficacy clinical trial; efficacy trial; evidence base; feasibility testing; flexibility; follow-up; healing; improved; mind/body; 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 (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： 重度抑郁症困扰着全世界超过 3 亿人，是导致残疾损失寿命的主要原因。目前的治疗方法在功效方面存在很大的局限性，并且在药物治疗的情况下，还存在严重的副作用。因此，迫切需要额外有效、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，全身身心健康（WBH）与认知行为疗法（CBT）（一种针对抑郁症的既定疗法）相结合可能特别有效。这种组合可能会增加抑郁症患者的突然收益（抑郁症状的快速改善）。突然的进步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，一次全身心放松会导致抑郁症患者的积极情绪突然获得和急剧增加，这与认知灵活性的增加有关。尽管试点研究的初步数据很有希望，但仍需要严格、精心设计的临床试验来制定包括 WBH 在内的抑郁症治疗建议。特别是，研究人员尚未调查身心整合（CBT）和身体（WBH）干预作为抑郁症潜在综合治疗方法的潜力。我们的目标是在本提案中为此类试验奠定基础。在目标 1（第 1 阶段）中，我们将进行单臂试验 (N=16)，以细化和优化将 WBH（每两周 4 次）与 CBT（每周 8 次）相结合的程序。在完成第一波 n=8 参与者的所有程序后，我们将迭代完善程序，然后再启动第二波 n=8 参与者。在第 1 阶段结束时，我们将完成第 2 阶段使用的组合干预组件的最终手册。在目标 2（第 2 阶段）中，我们将进行可行性试点试验（N = 30），其中我们随机分配参与者接受主动干预WBH（每两周一次）和 CBT（每周 8 次）干预或假 WBH（每两周 4 次）仅 CBT（每周 8 次）。上半年注册完成后（n = 15），我们将根据参与者和工作人员的反馈来完善剩余注册（n = 15；总共 N = 30）的程序。这项可行性试点试验将测试招募和随机化程序，为重度抑郁症参与者的多中心临床疗效试验做准备。这项工作对于改善抑郁症的治疗和增进对身心综合疗法治疗情绪障碍的作用的理解具有重要前景。