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

• 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
• 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; 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

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.

项目摘要/摘要 主要抑郁症（MDD）的一线治疗，包括认知行为疗法（CBT） 有限的有效性，约有约½患者在2年内未反应CBT和½复发。策略 我们以前已经表现出了大型的心理和 MDD成人运动后75分钟的神经可塑性改善。这会在神经上创建 肥沃的运动后窗口，有可能最大程度地提高CBT的影响 锻炼。我们已经开发了一种新型的治疗策略，使用有氧运动来启动随后的CBT 会话（'ActiveCBT'）。假设运动启动会导致更大的CBT机制参与 通过共同（例如，工作联盟）和特定（例如行为激活）因素进行的行动与 抑郁症状；这种CBT增强方法尚未经验测试。我们出版的 初步工作表明练习急性改善心理学（例如，状态抗甲基）和神经塑性（例如， MDD中的bdnf）标记，我们的n = 10个项目可行性试验表明后勤的可能性很高 运动启动对目标机制的成功和合理影响。 R61将包括为期8周 40名成年人的随机对照试验进行30分钟的中度运动或安静的休息 （ActiveCBT与Calmcbt）在每周CBT会议之前。使用时间和注意力匹配的控制 参与者将在这30分钟内观看标准化的纪录片系列，唯一 小组锻炼的区别。该项目还将采用尖端，机器学习和 通过LYSSN平台进行自然语言处理，以客观评估治疗。 R61的总体目标是 TO：1）表现出对目标CBT机制的运动启动效果（工作联盟和行为 激活），2）将心理和神经塑性运动启动与CBT机制联系起来，3）探索 从LYSSN到ActiveCBT诱导的治疗差异的基于机器学习的标记的敏感性。 在确定工作联盟和/或行为激活中的现代组间差异后 有利于ActiveCBT，R33将进行2：1随机，对照试验（n = 100），比较ActiveCBT 到Calmcbt。 R33的总体目标是：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有效性信号，并确定有效性的强度 与CBT机制链接。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，与 更大的工作联盟和/或行为激活。这些试验将确定随后的潜力 确认性效率试验严格测试运动启动的潜力以增强治疗。如果这个 创新的，生物知识的方法随后成功地“素数”，这可以用来用来 增强其他疗法和其他疾病，可显着改善心理健康治疗。