A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress

项目概要 癌症患者的非正式护理人员 (IC) 在医疗保健中发挥着越来越重要的作用 系统，处于严重和持续的焦虑和抑郁的显着风险，甚至高于水平 由他们提供护理的患者报告。认知行为疗法（CBT）已证明 对一般人群中的个人临床焦虑和抑郁症具有强大的疗效，但 CBT 已适应 癌症 IC 的结果相对不令人满意。对于这种低迷的一种可能的解释 功效在于，这些 CBT 并未全面针对通常构成困扰的因素 IC 人普遍经历的问题，例如注意力僵化和持续性消极思维（PNT；例如， 忧虑和沉思）。情绪调节疗法 (ERT) 是一种当代 CBT 干预措施，旨在 故意针对与护理相关的痛苦的潜在过程。 ERT 已确定疗效 以及对一系列针对慢性焦虑和抑郁的试验中提出的机制的初步支持，并且是 有前景的候选干预措施可以解决可能使 IC 焦虑的解决复杂化的机制 和抑郁症。以 ERT 为基础，我们开发了针对癌症护理人员的情绪调节疗法 (ERT- C）并证明了在减少抑郁和焦虑方面的可行性、可接受性和初步功效 症状、PNT 和情绪调节缺陷，并改善 IC 患者的生活质量 参加 ERT-C 提供的护理。在此应用中，我们建议更严格地评估 ERT-C 并阐明了减少痛苦的假设机制。通过多点试验，我们 将随机将 200 个 IC 分配到 ERT-C 或传统 CBT 的 8 个会话中，以评估小学和中学 基线、治疗后以及 3 个月和 6 个月随访时的结果。患者的治疗结果也将被收集 基线和 3 个月随访。我们预测 ERT-C 将与过度焦虑和 抑郁症患者的 IC 和 QOL 降低，治疗后六个月仍保持优势。 其次，我们预测 ERT 将在适应性情绪调节能力方面产生更大的收益，并且 这些技能将部分缓解抑郁和焦虑症状。我们将另外检查 压力（例如，昼间皮质醇）和炎症（即，可溶性肿瘤）的唾液标志物的相对变化 坏死因子-α 受体 II、CRP、白细胞介素 6）在接受 ERT-C 与 CBT 的 IC 中进行比较，并预测 ERT- 与 CBT 相比，C 将更大程度地减少皮质醇失调和全身炎症，并且 这些成果将在 6 个月的后续行动中保持。我们的研究结果将推动 IC 干预科学的发展 通过解决我们领域中强大、快速和有效解决 IC 问题的能力的关键差距来开展研究 焦虑和抑郁。

PROJECT SUMMARY Informal caregivers (ICs) of patients with cancer, who play an increasingly crucial role in the healthcare system, are at significant risk for severe and persistent anxiety and depression, even higher than levels reported by the patients for whom they provide care. Cognitive behavioral therapy (CBT) has demonstrated robust efficacy for clinical anxiety and depression for individuals in the general population, but CBTs adapted for cancer ICs evidence comparatively unsatisfying outcomes. One possible explanation for this lackluster efficacy is that these CBTs do not comprehensively target the factors that typically comprise the distress commonly experienced by ICs, such as attentional rigidity and perseverative negative thinking (PNT; e.g., worry and rumination). Emotion Regulation Therapy (ERT) is a contemporary CBT intervention developed to deliberately target processes underlying the distress associated with caregiving. ERT has established efficacy and initial support for proposed mechanisms in a series of trials for chronic anxiety and depression and is a promising candidate intervention to address the mechanisms likely complicating the resolution of IC anxiety and depression. Predicated on ERT, we developed Emotion Regulation Therapy for Cancer Caregivers (ERT- C) and demonstrated feasibility, acceptability, and initial efficacy in reducing depression and anxiety symptoms, PNT and emotion regulation deficits, and improving the quality of life of patients for whom ICs enrolled in ERT-C provided care. In this application, we propose to more stringently evaluate the efficacy of ERT-C and elucidate hypothesized mechanisms underlying reductions in distress. Through a multi-site trial, we will randomize 200 ICs to 8 sessions each of ERT-C or traditional CBT to evaluate primary and secondary outcomes at baseline, post-treatment, and at 3-and 6-months follow-up. Patient outcomes will also be collected at baseline and 3-months follow-up. We predict that ERT-C will be associated with superior anxiety and depression reductions in ICs and QOL in patients, with advantages maintained six months following treatment. Secondarily, we predict that ERT will produce greater gains in adaptive emotion regulation capacity and that these skills will partially mediate reductions in depression and anxiety symptoms. We will additionally examine the relative change in salivary markers of stress (e.g., diurnal cortisol) and inflammation (i.e., soluble tumor necrosis factor-alpha receptor II, CRP, Interleukin 6) in ICs receiving ERT-C versus CBT and predict that ERT- C will result in greater reductions in cortisol dysregulation and systemic inflammation as compared to CBT, and these gains will be maintained at 6-months follow-up. Our results will advance the science of IC intervention research by addressing a critical gap in our field’s ability to powerfully, quickly and effectively address IC anxiety and depression.