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.

项目总结/摘要 重度抑郁症困扰着全球3亿多人，是导致生命的主要原因 因残疾而失去的岁月目前的治疗方法在疗效上有很大的局限性，在药物治疗的情况下， 严重的副作用。因此，迫切需要额外的有效，耐受性良好的治疗。一 这种潜在治疗是全身热疗（WBH）。我们推测，WBH可能特别是 有效的结合认知行为疗法（CBT），一个既定的治疗抑郁症。这 联合用药可能会增加患有抑郁症的个体的突然收益（抑郁症状的快速改善）。 萧条突然的收益预示着抑郁症的持久改善。在两个成年人的小样本中， 抑郁症，一个单一的会议WBH沉淀突然收益和积极影响的急性增加， 与抑郁症患者认知灵活性的增加有关。尽管最初有希望 为了开发治疗方法，需要从试点研究中获得数据，进行严格的、设计良好的临床试验 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 综合身心（CBT）干预作为潜在综合治疗的潜力 抑郁症的治疗方法我们的目的是在本提案中为此类试验奠定基础。在目标1（阶段1）中，我们 将进行一项单臂试验（N=16），以完善和优化整合WBH（每周8次）的程序 CBT（每周8次）。我们将在完成所有程序后迭代完善程序 在启动第二波n = 8名参与者之前，对第一波n =8名参与者进行测试。阶段结束时 1.我们将完成第二阶段使用的综合干预组成部分的最终手册。在目标2中 （第2阶段）我们将进行一项可行性试点试验（N=30），在该试验中，我们将受试者随机接受 综合WBH（每周8次）和CBT（每周8次）干预或仅单独CBT（8 每周会议）。上半年入组完成后（n=15），我们将使用参与者和工作人员的反馈 完善剩余入组的程序（n=15;共N=30）。这一可行性试点试验将测试 招募和随机化程序，为参与者的多中心临床疗效试验做准备 患有严重抑郁症。这项工作对改善抑郁症的治疗和促进 理解身心综合疗法对情绪障碍的作用。