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

癌症护理人员情绪调节疗法的随机对照试验：解决护理人员困扰的机制靶向方法

基本信息

批准号：
10614521
负责人：
Allison Applebaum
金额：
$ 59.8万
依托单位：
SLOAN-KETTERING INST CAN RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2025-05-31
项目状态：
未结题

项目摘要

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.

项目摘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重大风险，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）已经证明，对于一般人群中的个体，CBT对临床焦虑和抑郁具有强大的疗效，但CBT适用于对于癌症IC证据相对不令人满意的结果。一个可能的解释是，有效性在于，这些能力建设疗法并没有全面地针对通常构成痛苦的因素通常由IC经历，如注意力僵化和持续性消极思维（PNT;例如，焦虑和沉思）。情绪调节疗法（ERT）是一种当代CBT干预措施，故意针对与抑郁相关的痛苦背后的过程。ERT已确立疗效在一系列慢性焦虑和抑郁症的试验中，有希望的候选干预措施，以解决可能使IC焦虑的解决复杂化的机制和抑郁症在ERT的基础上，我们开发了癌症护理人员情绪调节疗法（ERT- C）并证明了在减轻抑郁和焦虑方面的可行性、可接受性和初步疗效症状，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。在本申请中，我们建议更严格地评估 ERT-C和阐明减少痛苦的假设机制。通过多中心试验，我们我将200个IC随机分配到ERT-C或传统CBT的8个会话中，以评估初级和次级基线、治疗后以及3个月和6个月随访时的结局。还将收集患者结局在基线和3个月随访时。我们预测ERT-C将与上级焦虑相关，抑郁症患者的IC和QOL降低，治疗后6个月保持优势。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，这些技能将部分减轻抑郁和焦虑症状。我们还将研究应激的唾液标志物的相对变化（例如，昼夜皮质醇）和炎症（即，可溶性肿瘤在接受ERT-C与CBT的IC中，与CBT相比，C将导致皮质醇失调和全身炎症的更大减少，这些增益将在6个月随访时保持。我们的研究结果将推动IC干预科学的发展通过解决我们的领域的能力，强大，快速和有效地解决IC的关键差距的研究焦虑和抑郁。