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

• 批准号: 10250395
• 负责人: Allison Applebaum
• 金额: $ 60.84万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/10250395
• 关键词: Address; Aftercare; Alcohol consumption; Anxiety; Attention; Behavioral; Biological; Blood Pressure; Cancer Patient; Cardiovascular Diseases; Caregivers; Caring; Chronic; Chronic stress; Cognitive Therapy; Disease; Distress; Emotional; Endocrine; Enrollment; Friends; General Population; Health; Health Care Costs; Health behavior; Healthcare Systems; Heart Rate; Hydrocortisone; Hyperphagia; Individual; Inflammation; Interleukin-6; Intervention; Intervention Studies; Link; Major Depressive Disorder; Malignant Neoplasms; Mediating; Mediation; Medical; Medical Care Team; Mental Depression; Mind; Mission; Outcome; Patient Care; Patient Care Team; Patient-Focused Outcomes; Patients; Play; Process; Production; Quality of life; Randomized; Randomized Controlled Trials; Regulation; Reporting; Resolution; Risk; Role; Salivary; Science; Series; Shoulder; Site; Sleeplessness; Stress; TNFRSF1A gene; Therapeutic Intervention; Thinking; Time; Tobacco use; Training Support; Uncompensated Care; United States; United States National Institutes of Health; Vertebral column; Waiting Lists; Work; anxiety symptoms; cancer therapy; care coordination; caregiving; clinical anxiety; clinical efficacy; comparative; control trial; coping; cost; cytokine; depressive symptoms; efficacy evaluation; emotion regulation; experience; flexibility; follow-up; health care service utilization; improved; indexing; informal caregiver; member; mindfulness meditation; multi-site trial; perceived stress; primary outcome; psychosocial; secondary outcome; skills; skills training; social; sustained attention; systemic inflammatory response; therapy development

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.

项目总结