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

项目总结 癌症患者的非正式照顾者(IC)，他们在医疗保健中发挥着越来越重要的作用 严重和持续焦虑和抑郁的风险很大，甚至高于 由他们提供护理的患者报告。认知行为疗法已经证明 对一般人群中的个人临床焦虑和抑郁有很强的疗效，但CBTS适应 对于癌症ICS来说，结果相对不令人满意。对这种低迷的一个可能的解释是 有效性在于，这些CBT并不全面地针对通常构成痛苦的因素 IC通常经历的，例如注意僵化和持之以恒的消极思维(PNT；例如， 担心和沉思)。情绪调节疗法(ERT)是当代发展起来的一种CBT干预方法 刻意针对与照料相关的痛苦的潜在过程。ERT已经确立了疗效 以及对慢性焦虑和抑郁的一系列试验中提出的机制的初步支持，是 有希望的候选干预措施来解决可能使IC焦虑的解决复杂化的机制 和抑郁症。基于ERT，我们开发了针对癌症照顾者的情绪调节疗法(ERT- C)并证明了减少抑郁和焦虑的可行性、可接受性和初步效果 症状、PNT和情绪调节缺陷与ICS患者生活质量的改善 参加ERT-C提供了护理。在本应用程序中，我们建议更严格地评估 ERT-C，并阐明减少痛苦的假设机制。通过多点试验，我们 将200个IC随机分配到ERT-C或传统CBT的8个会话，以评估主要和次要 基线、治疗后、3个月和6个月随访的结果。还将收集患者的结果 基线和3个月随访。我们预测ERT-C将与优越焦虑和 患者ICS和生活质量中抑郁的减少，并在治疗后六个月保持优势。 其次，我们预测ERT将在适应情绪调节能力方面产生更大的收益，并且 这些技能将在一定程度上缓解抑郁和焦虑症状。我们还将进一步检查 唾液应激标志物(如昼夜皮质醇)和炎症标志物(即可溶性肿瘤)的相对变化 在接受ERT-C和CBT的ICS中预测ERT-C。 与CBT相比，C将导致皮质醇失调和全身炎症的更大程度的减少，以及 这些收益将在6个月的随访期内保持。我们的研究结果将推动IC介入科学的发展 通过解决我们的领域在有力、快速、有效地解决IC问题的能力方面的关键差距进行研究 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.