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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要重度抑郁症困扰着全球超过 3 亿人，是影响生命的主要原因因残疾而损失的岁月。目前的治疗方法在疗效上存在很大的局限性，就药物而言，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。一这种潜在的治疗方法是全身热疗（WBH）。我们假设 WBH 可能特别重要与认知行为疗法 (CBT) 结合使用会有效，认知行为疗法是抑郁症的既定治疗方法。这组合可能会增加患有以下疾病的个体的突然收益（抑郁症状的快速改善）沮丧。突然的进步预示着抑郁症的持久改善。在两个小样本的成年人中抑郁症中，单次全身心放松会导致积极情绪的突然增益和急剧增加，这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，需要来自试点研究的数据、严格的、精心设计的临床试验针对抑郁症的建议，包括 WBH。特别是，研究人员尚未调查综合思想（CBT）和身体（WBH）干预作为潜在综合治疗的潜力治疗抑郁症的方法。我们的目标是在本提案中为此类试验奠定基础。在目标 1（第一阶段）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 会话）和 CBT（每周 8 次会话）。完成所有流程后我们会迭代完善流程在启动第二波 n=8 参与者之前，先进行第一波 n=8 参与者。阶段结束时 1 我们将完成第 2 阶段使用的组合干预组件的最终手册。目标 2 （第 2 阶段）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以获得综合 WBH（每周 8 次）和 CBT（每周 8 次）干预或仅独立 CBT（8 每周一次）。上半年报名完成后（n=15），我们将使用参与者和工作人员的反馈完善剩余注册的程序（n=15；总共 N=30）。本次试点将检验可行性为参与者进行多中心临床疗效试验做准备的招募和随机化程序患有严重抑郁症。这项工作对于改善抑郁症的治疗和进步具有重要的希望了解身心综合疗法对情绪障碍的作用。