针对癌症照护者痛苦的情绪调节疗法与认知行为疗法的随机对照试验。
完整摘要 · 中文译文
背景：认知行为疗法（CBT）在缓解癌症照护者的心理困扰方面显示出前景，尽管结果不一。传统CBT可能无法充分解决照护者困扰背后的跨诊断过程，如注意僵化和持续性思维。情绪调节疗法（ERT）是一种针对这些机制的当代CBT，对癌症照护者（ERT-C）可能具有前景。我们比较了ERT-C与照护者适应性CBT（CBT-C）在照护者和患者报告结局方面的差异。 方法：我们开展了一项多中心随机对照试验（ERT-C vs. CBT-C），纳入患有任何癌症类型或分期的患者的心理困扰照护者。照护者在基线、治疗后以及3个月和6个月随访时完成焦虑、抑郁、担忧、反刍、负担和生活质量（QOL）的测量。患者在基线和3个月时报告结局。使用多重插补的线性混合效应模型评估组间差异。 结果：从2021年3月至2024年4月，我们随机分配了253名照护者，其中244名被纳入分析（ERT-C = 124；CBT-C = 120），并纳入了95名患者（ERT-C = 47；CBT-C = 48），其中87名被纳入分析。从治疗前到治疗后以及6个月随访期间，ERT-C组的照护者并没有比CBT-C组获得显著更大的改善。尽管患者的身心健康存在显著的组间差异，但这些效应在多重性校正后未持续存在。然而，照护者总体上在焦虑、抑郁、担忧和生活质量方面随时间表现出显著改善，患者在感知压力和急诊就诊方面表现出显著改善。 结论：尽管ERT-C未优于CBT-C，但照护者总体上表现出有意义的心理社会改善，患者在2项结局上有所改善。未来研究将探讨这两种治疗是否差异性地作用于假定的机制，从而导致所观察到的临床发现。 临床试验注册：本试验已在ClinicalTrials.gov注册（标识号：NCT04802720）。 癌症照护者——即癌症患者的父母、伴侣、子女、兄弟姐妹和朋友——承担着重大责任，并且面临焦虑和抑郁的风险。虽然认知行为疗法（CBT）在解决各种临床人群中的焦虑和抑郁方面拥有最强有力的证据，但在癌症照护者中发现的混合结果可能反映了传统CBT在解决这一弱势群体所经历的独特痛苦方面的局限性。我们团队开发了针对癌症照护者的情绪调节疗法（ERT-C），这是一种基于CBT的方法，针对担忧和反刍思维，并且可能为照护者提供比传统CBT更特别的益处。本研究比较了8次ERT-C与8次针对癌症照护者的认知行为疗法（CBT-C）的相对疗效，通过远程医疗对253名痛苦照护者实施，这些照护者照顾的是所有癌症部位和分期的患者。我们关于ERT-C将优于CBT-C的假设未得到支持；两组在焦虑、抑郁、担忧和生活质量方面均显示出显著改善。在纳入照护者所照顾的患者中，感知压力和急诊就诊次数在两组中也均有显著改善。我们的结果突显了一个关键教训：对于癌症患者的痛苦照护者，参与任何以证据为基础、以CBT为指导并针对照护者特定痛苦的干预措施可能都是有益的。
完整摘要 · 英文原文
BACKGROUND: Cognitive Behavioral Therapy (CBT) shows promise for addressing distress in cancer caregivers, though results are mixed. Traditional CBT may not fully address transdiagnostic processes underlying caregiver distress, such as attentional rigidity and perseverative thinking. Emotion Regulation Therapy (ERT), a contemporary CBT targeting these mechanisms, has promise for cancer caregivers (ERT-C). We compared ERT-C to caregiver-adapted CBT (CBT-C) on caregiver- and patient-reported outcomes. METHODS: We conducted a multisite RCT (ERT-C vs. CBT-C) with distressed caregivers of patients with any cancer type or stage. Caregivers completed measures of anxiety, depression, worry, rumination, burden, and quality of life (QOL) at baseline, post-treatment, and 3- and 6-months follow-up. Patients reported outcomes at baseline and 3 months. Linear mixed-effects models with multiple imputation were used to assess group differences. RESULTS: From March 2021 to April 2024, we randomized 253 caregivers, of whom 244 were analyzed (ERT-C = 124; CBT-C = 120), and enrolled 95 patients (ERT-C = 47; CBT-C = 48), of whom 87 were analyzed. From pre- to post-treatment and through 6 months follow-up, caregivers in ERT-C did not improve significantly more than in CBT-C. Although there were significant between-group differences in patient physical and mental health, these effects did not persist after multiplicity adjustment. However, caregivers overall demonstrated significant improvements over time in anxiety, depression, worry, and QOL, and patients demonstrated significant improvements in perceived stress and emergency room visits. CONCLUSIONS: Although ERT-C was not superior to CBT-C, caregivers showed meaningful psychosocial improvements overall, and patients improved on 2 outcomes. Future work will examine whether the 2 treatments differentially engage putative mechanisms leading to the observed clinical findings. CLINICAL TRIAL REGISTRATION: This trial is registered on ClinicalTrials.gov (identifier: NCT04802720). Cancer caregivers—the parents, partners, children, siblings, and friends of patients with cancer—shoulder significant responsibilities and are at risk for anxiety and depression. While Cognitive Behavioral Therapy (CBT) has the strongest evidence to address anxiety and depression across various clinical populations, mixed findings among cancer caregivers may reflect the limitations of traditional CBT to address the unique distress experienced by this vulnerable population. Our group developed Emotion-Regulation Therapy for Cancer Caregivers (ERT-C), a CBT-based approach that targets worry and rumination and which may offer a particular benefit for caregivers above traditional CBT. This study compared the relative efficacy of 8 sessions of ERT-C compared to 8 sessions of Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C), delivered over telehealth to 253 distressed caregivers of patients with all sites and stages of cancer. Our hypothesis that ERT-C would outperform CBT-C was not supported; both groups showed significant improvements in anxiety, depression, worry, and quality of life. There were also significant improvements across both groups among the patients for whom enrolled caregivers provided care in perceived stress and emergency room visits. Our results highlight a critical lesson: For distressed caregivers of patients with cancer, engagement in any evidence-based CBT-informed intervention targeting caregiver-specific distress may be beneficial.