Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial

对罹患癌症的父母进行以意义为中心的悲伤治疗：一项多中心随机对照试验

• 批准号: 10298966
• 负责人: Wendy G. Lichtenthal
• 金额: $ 81.15万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-26 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10298966
• 关键词: Address; Advanced Malignant Neoplasm; Anxiety; Bereavement; Blinded; COVID-19; Cancer Patient; Caregivers; Caring; Cessation of life; Child; Communities; Complement; Complement 2; Data; Diagnostic; Dissemination and Implementation; Distress; Emotional; Evaluation; Evidence based intervention; Face; Fathers; Feeling hopeless; Goals; Grief reaction; Health Services Accessibility; Health behavior; Healthcare; Heart Diseases; Home; Institution; Intervention; Intervention Studies; Interview; Left; Life; Logistics; Malignant Neoplasms; Measurable; Measures; Mediating; Mediator of activation protein; Mental Depression; Mental Health; Methods; Mothers; Outcome; Outcome Study; Pain; Palliative Care; Parents; Patient Self-Report; Population; Populations at Risk; Productivity; Psychotherapy; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Research; Research Personnel; Risk; Role; Sampling; Services; Structure; Symptoms; Therapeutic; Time; Treatment Efficacy; Underserved Population; Videoconferencing; Work; arm; barrier to care; base; community setting; comparative efficacy; depressive symptoms; design; evidence base; experience; fighting; high risk; improved; innovation; intervention effect; neglect; novel; physical conditioning; post intervention; primary outcome; public health priorities; recruit; response; secondary outcome; sound; telehealth; therapy development; treatment arm; treatment as usual; treatment effect; trial comparing

Project Summary/Abstract Bereavement support is a core tenet of comprehensive palliative care. Yet, accessible, evidence-based interventions are limited, particularly for bereaved parents. Losing a child to cancer is one of the most devastating experiences a parent can endure. Bereaved parents are at higher risk for numerous poor mental and physical health outcomes, including prolonged grief (PG), depression, reduced quality of life, existential distress, decreased work productivity, adverse health behaviors, and even death. Despite their suffering, bereaved parents report emotional and logistical barriers to returning to the institution where their child was treated and do not know where to turn for support in their communities, resulting in underutilization of services. The need for empirically-supported, conceptually sound, acceptable, and accessible interventions for bereaved parents is clear. Grief researchers have long emphasized the therapeutic value of facilitating meaning-making to improve bereavement outcomes. However, meaning-based interventions have not been empirically evaluated for grieving parents. To address this, we developed a manualized intervention, Meaning-Centered Grief Therapy (MCGT), for this critically at-risk and underserved population. Our pilot randomized controlled trial (RCT) comparing MCGT to supportive psychotherapy (SP), the most commonly received grief therapy, showed that MCGT outperformed SP for parents with higher baseline PG levels, improving PG, depression, anxiety, hopelessness, and quality of life domains. It also showed that telehealth delivery in parents’ homes was feasible and could reduce access-to-care barriers. In the wake of COVID-19, telehealth grief interventions are needed now more than ever, and yet evidence is scant. To improve the quality of home-based palliative care through enhanced bereavement services, the objective of the proposed mixed methods, multisite 3-arm RCT is to build on our prior work and examine which grief interventions delivered in the home via telehealth work best for whom and why. We will compare the efficacy of MCGT to SP and enhanced usual care (EUC) for bereaved parents with elevated PG symptoms. Primary outcomes will be reduced PG and depression symptoms. We will randomize 265 bereaved parents recruited from four institutions and the community to MCGT, SP, or EUC. We will embed qualitative interviews concurrently with quantitative measures, which is an innovation in grief intervention research. Self-report measures, as well as blinded diagnostic interviews to increase rigor, will be given at multiple time points through 6 months post-intervention. We will conduct qualitative interviews about the interventions’ impact in a purposively sampled subset (n=48). The specific aims of this trial are: 1) to compare the efficacy of MCGT, SP, and EUC in reducing PG and depression symptoms in bereaved parents, 2) to contextualize quantitative findings with qualitative data, and 3) to explore mediators and moderators of outcomes. The long-term goal of our research is to identify an effective, accessible telehealth grief intervention that improves suffering in the bereaved as part of comprehensive palliative care.

项目摘要/摘要 支持丧亲之痛是全面姑息治疗的核心原则。然而，容易接近，以证据为基础 干预措施是有限的，特别是对失去亲人的父母。死于癌症的孩子是最多的 父母可以忍受毁灭性的经历。失去亲人的父母患上许多精神疾病的风险更高 以及身体健康结果，包括长期悲伤(PG)、抑郁、生活质量下降、生存 痛苦、工作效率下降、不良健康行为，甚至死亡。尽管他们受苦受难， 失去亲人的父母报告说，回到他们孩子所在的机构的情感和后勤障碍 他们接受了治疗，不知道在社区向哪里寻求支持，导致服务得不到充分利用。 需要有经验支持的、概念上合理的、可接受的和可获得的对失去亲人的干预 父母是明确的。悲伤研究人员长期以来一直强调促进意义产生的治疗价值 以改善丧亲结果。然而，基于意义的干预还没有被经验证明 为悲痛的父母进行评估。为了解决这个问题，我们开发了一种以意义为中心的手动干预 悲伤疗法(MCGT)，针对这一处于严重风险和服务不足的人群。我们的飞行员随机对照 试验(RCT)比较MCGT和支持性心理疗法(SP)，这是最常接受的悲痛疗法， 结果显示，对于基线PG水平较高的父母，MCGT的表现优于SP，改善了PG，抑郁， 焦虑、绝望和生活质量领域。研究还表明，在父母家里进行远程医疗服务 这是可行的，可以减少获得保健的障碍。在新冠肺炎之后，远程医疗悲痛干预 现在比以往任何时候都更需要，但证据很少。提高居家姑息治疗的质量 通过加强丧亲服务进行护理，拟议的混合方法的目标是多地点三臂 RCT是建立在我们之前工作的基础上，并检查哪些悲伤干预是通过远程医疗在家里提供的 为谁和为什么工作最好。我们将比较MCGT与SP和增强型日常护理(EUC)的疗效 失去双亲，PG症状升高。主要结果将是PG减少和抑郁 症状。我们将随机从四个机构和社区招募265名失去亲人的父母 MCGT、SP或EUC。我们将在量化措施的同时嵌入定性访谈，这是一种 悲伤干预研究的创新。自我报告措施，以及盲目诊断性访谈 增加严格性，将在干预后6个月的多个时间点给予。我们将进行 在有目的抽样的子集(n=48)中，对干预措施的影响进行定性访谈。具体目标 本试验的主要目的是：1)比较MCGT、SP和EUC在减少精神分裂症和抑郁症状方面的疗效。 失去父母，2)将定量结果与定性数据联系起来，3)探索中介因素 和结果的协调者。我们研究的长期目标是找出一种有效的、可访问的 作为全面姑息治疗的一部分，远程保健悲痛干预可以改善丧亲者的痛苦。