ActiveCBT for depression: Transforming treatment through exercise priming

ActiveCBT 治疗抑郁症：通过运动启动改变治疗方法

基本信息

批准号：
10629807
负责人：
Jacob D Meyer
金额：
$ 75.18万
依托单位：
IOWA STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-06-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10629807
关键词：
Acute Adult Aerobic Exercise Anhedonia Anxiety Attention Behavioral Biological Brain-Derived Neurotrophic Factor Clinical Cognitive Therapy Collaborations Data Disease Effectiveness Empathy Exercise Exercise Therapy Fertile Period Goals Hamilton Rating Scale for Depression Intervention Investigational Therapies Ketamine Link Machine Learning Major Depressive Disorder Measures Mental Depression Mental Health Modeling Moderate Exercise Natural Language Processing Nature Neurologic Neuronal Plasticity Outcome Participant Patient Self-Report Patients Persons Pharmaceutical Preparations Phase Post-Traumatic Stress Disorders Psychotherapy Publishing Randomized Randomized, Controlled Trials Relapse Research Rest Series Signal Transduction Standardization Techniques Testing Time Treatment Effectiveness Treatment outcome Work antidepressant effect confirmatory trial depressive symptoms feasibility trial improved innovation meetings novel pilot trial portability psychologic success treatment effect treatment strategy

项目摘要

PROJECT SUMMARY/ABSTRACT Frontline treatments for major depressive disorder (MDD), including cognitive behavioral therapy (CBT), have limited effectiveness, with ~½ of patients not responding to CBT and ½ relapsing within 2 years. Strategies that could increase the potency of MDD treatments are needed. We have previously shown large psychological and neuroplasticity improvements for 75 minutes post-exercise in adults with MDD. This creates a neurologically fertile post-exercise window with the potential to maximize the effects of CBT performed immediately after exercise. We have developed a novel treatment strategy using aerobic exercise to prime a subsequent CBT session (‘ActiveCBT’). Exercise priming is hypothesized to lead to greater engagement of CBT mechanisms of action through both common (e.g., working alliance) and specific (e.g., behavioral activation) factors linked to depression outcomes; this CBT augmentation approach has yet to be empirically tested. Our published and preliminary work show exercise acutely improves psychological (eg, state anhedonia) and neuroplastic (eg, BDNF) markers in MDD, and our n=10 pilot feasibility trial of this project indicates high likelihood for logistical success and plausible effects of exercise priming on target mechanisms. The R61 will consist of an 8-week randomized controlled trial in 40 adults with MDD performing 30-minutes of moderate exercise or quiet rest (ActiveCBT vs. CalmCBT) prior to weekly CBT sessions. Using a time- and attention-matched control, all participants will view a standardized documentary series for these 30 pre-therapy minutes with the only difference between groups being exercise. This project will also employ cutting-edge, machine learning and natural language processing via the Lyssn platform to objectively evaluate therapy. The overall R61 goals are to: 1) demonstrate exercise priming effects on target CBT mechanisms (working alliance and behavioral activation), 2) link psychological and neuroplastic exercise priming to CBT mechanisms, and 3) explore sensitivity of objective machine learning-based markers from Lyssn to ActiveCBT-induced therapy differences. Upon identification of a moderate between-group difference in working alliance and/or behavioral activation favoring ActiveCBT, the R33 will proceed with a 2:1 randomized, controlled trial (n=100), comparing ActiveCBT to CalmCBT. The overall R33 goals are to: 1) confirm effects of exercise priming on target CBT mechanisms, and 2) determine the preliminary efficacy signal of exercise priming, and determine the strength of the efficacy link with CBT mechanisms. Our working hypotheses are that we will confirm higher working alliance and/or behavioral activation in ActiveCBT, with greater depression effects at 8 weeks and 12 weeks later linked to greater working alliance and/or behavioral activation. These trials will establish the potential for a subsequent confirmatory efficacy trial to rigorously test the potential of exercise priming to enhance treatment. If this innovative, biologically-informed approach successfully ‘primes’ subsequent therapy, this could be used to augment other treatments and in other disorders, significantly improving mental health treatment.

项目概要/摘要重度抑郁症 (MDD) 的一线治疗，包括认知行为疗法 (CBT)，已效果有限，大约 1/2 的患者对 CBT 没有反应，1/2 的患者在 2 年内复发。我们之前已经表明，需要增加 MDD 治疗的效力。患有重度抑郁症的成年人运动后 75 分钟神经可塑性得到改善，这产生了神经学上的改善。运动后的生育窗口，有可能最大限度地发挥运动后立即进行的 CBT 的效果我们开发了一种新的治疗策略，使用有氧运动来启动后续的 CBT。活动启动被捕获以导致 CBT 机制的更大参与。通过共同因素（例如工作联盟）和特定因素（例如行为激活）采取行动抑郁症的结果；这种 CBT 增强方法尚未经过我们发表和验证。初步研究表明，运动可以显着改善心理（例如，状态快感缺乏）和神经可塑性（例如， MDD 中的 BDNF）标记，我们对该项目的 n=10 试点可行性试验表明后勤保障的可能性很高 R61 将包括为期 8 周的运动启动对目标机制的成功和合理影响。对 40 名重度抑郁症成人进行的随机对照试验，进行 30 分钟的适度运动或安静休息（ActiveCBT 与 CalmCBT）在每周 CBT 课程之前使用时间和注意力匹配的控制。参与者将观看治疗前 30 分钟的标准化纪录片系列该项目还将采用尖端的机器学习和技术来区分各组之间的差异。通过 Lyssn 平台进行自然语言处理来客观评估治疗 R61 的总体目标是。 1) 展示运动对目标 CBT 机制的启动效应（工作联盟和行为激活），2）将心理和神经可塑性运动启动与 CBT 机制联系起来，3）探索 Lyssn 中基于机器学习的客观标记对 ActiveCBT 引起的治疗差异的敏感性。在发现工作联盟和/或行为激活方面存在适度的组间差异后支持 ActiveCBT，R33 将进行 2:1 随机对照试验 (n=100)，比较 ActiveCBT CalmCBT 的总体 R33 目标是：1) 确认运动启动对目标 CBT 机制的影响， 2)确定运动启动的初步功效信号，并确定功效的强度我们的工作假设是我们将确认更高的工作联盟和/或 ActiveCBT 中的行为激活，在 8 周和 12 周后具有更大的抑郁效应，与更大的工作联盟和/或行为激活这些试验将为后续建立潜力。验证性疗效试验严格测试运动启动增强治疗的潜力。创新的、基于生物学的方法成功地“启动”了后续治疗，这可用于显着增强其他治疗和其他疾病，改善心理健康治疗。