Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial

早期适应不良悲伤的加速解决疗法：临床试验

• 批准号: 10578937
• 负责人: Cindy Tofthagen
• 金额: $ 67.28万
• 依托单位: MAYO CLINIC JACKSONVILLE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-15 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10578937
• 关键词: Acceleration; Acute; Address; Aging; Assessment tool; Attention; Bereavement; Caregiver Burden; Caregivers; Cessation of life; Characteristics; Chronic Disease; Chronic stress; Clinical Trials; Cognitive; Data; Data Collection; Distress; Double-Blind Method; Early Intervention; Early treatment; Education; Elderly; Emotional; Enrollment; Equipment and supply inventories; Event; Evidence based treatment; Family; Family Caregiver; Family member; Friends; Future; Geographic Locations; Goals; Grief reaction; Health; Hobbies; Individual; Intervention; Interview; Life; Mental Depression; Methods; Morbidity - disease rate; Outcome; Palliative Care; Participant; Persons; Physical Function; Pragmatic clinical trial; Prevention; Process; Psychological Factors; Psychotherapy; Quality of life; Randomized; Recovery; Research; Resolution; Resources; Risk; Science; Social support; Stress; Structure; Subgroup; Symptoms; Testing; Therapeutic Intervention; Time; Trauma; Veterans; Waiting Lists; acute stress; advanced disease; arm; attentional control; biological adaptation to stress; brief intervention; cognitive process; coping; effective intervention; efficacy evaluation; efficacy testing; experience; immune function; improved; instrument; loved ones; mental function; mortality; predicting response; prevent; preventive intervention; primary outcome; programs; psychologic; randomized, clinical trials; response; screening; social; social factors; stress related disorder; success; time use; traumatic event; treatment as usual; treatment response

PROJECT SUMMARY/ABSTRACT Maladaptive grief negatively impacts 25-40% of older adult family caregivers of persons with a serious chronic illness, with adverse health outcomes including increased morbidity and mortality, reduced independence, and diminished immune function.1-4 Losses associated with aging, such as the death of multiple close family and friends, are highly traumatic and contribute to the devastating impact of maladaptive grief among older adults.8,10 Brief, effective interventions that address maladaptive grief early in the grief trajectory are urgently needed. Accelerated Resolution Therapy (ART) is an evidence-based treatment for post-traumatic distress in civilians and veterans14-17 that may be useful in alleviating maladaptive grief prior to bereavement and could prevent prolonged, complicated grief following bereavement. We are proposing to test the efficacy of ART, a low-risk, brief therapy with a strong theoretical rationale for treatment success in maladaptive grief and supported by the promising results of our recently completed preliminary trial (R21AG056584). Additional aims of the study are to examine changes in cognitive appraisal and integration of loss following ART using a mixed methods approach and to evaluate personal, social, and psychological factors predictors of response. During the proposed double blinded, randomized, controlled two arm clinical trial, 472 older adult family caregivers from two different geographic locations will receive either ART or an educational program that is matched for time and attention. Each participant will receive four sessions of either the ART intervention or the control intervention. Data collection will occur at screening/enrollment (T1), at the end of the 4-session intervention period (T2) and at 6-months (T3) and 12-months post bereavement (T4). A subgroup of 20 participants randomly assigned to ART will participate in semi-structured interviews to enhance understanding of cognitive appraisal and integration of loss. This trial will provide critical information on the efficacy of the ART intervention as a potential first-line treatment option for pre-loss grief and preventative option for complicated grief and contribute new information about characteristics of individuals most likely to benefit from ART.

项目总结/摘要 适应不良性悲伤对25-40%的严重慢性病患者的老年家庭照顾者产生了负面影响。 疾病，对健康造成不良后果，包括发病率和死亡率增加，独立性降低， 免疫功能下降。1 -4与衰老相关的损失，如多个近亲的死亡， 朋友，是高度创伤性的，并有助于老年人适应不良悲伤的破坏性影响， 8，10在悲伤轨迹的早期解决适应不良悲伤的简短有效的干预措施是迫切的。 needed. 加速康复疗法（ART）是一种针对平民创伤后痛苦的循证治疗方法 和退伍军人14 -17，可能有助于减轻丧亲前的适应不良悲伤，并可以防止 丧亲之痛后的长期复杂的悲痛我们建议测试ART的疗效，一种低风险， 简短的治疗与强大的理论基础，治疗成功的适应不良悲伤和支持， 我们最近完成的初步试验（R21 AG 056584）的结果令人鼓舞。研究的其他目的是 使用混合方法检查ART后认知评估和损失整合的变化 方法和评估个人，社会和心理因素的预测反应。 在拟定的双盲、随机、对照两组临床试验中，472名老年人家庭 来自两个不同地理位置的护理人员将接受ART或教育计划， 匹配时间和注意力。每位参与者将接受四次ART干预或 控制干预。数据收集将在筛选/入组（T1）时、4个阶段结束时进行 干预期（T2）以及丧亲后6个月（T3）和12个月（T4）。20人小组 被随机分配到ART的参与者将参加半结构化访谈，以加强理解 认知评估和整合损失的能力。 这项试验将提供关于ART干预作为潜在一线治疗的有效性的关键信息 选择损失前的悲伤和预防选择复杂的悲伤，并提供新的信息， 最有可能从ART中获益的个体的特征。