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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要适应不良的悲伤对 25-40% 患有严重慢性病患者的老年人家庭照顾者产生负面影响疾病，带来不利的健康后果，包括发病率和死亡率增加、独立性降低，以及免疫功能减弱。1-4 与衰老相关的损失，例如多个亲密家庭的死亡和朋友们，他们遭受了极大的创伤，并加剧了老年人适应不良的悲伤的破坏性影响 8,10 迫切需要采取简短、有效的干预措施来解决悲伤轨迹早期的适应不良悲伤问题需要。加速解决疗法 (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之痛之前适应不良的悲伤，并可以预防丧亲之痛后的长期、复杂的悲伤。我们提议测试 ART 的功效，这是一种低风险、简短的治疗，具有强有力的理论依据，可以成功治疗适应不良的悲伤，并得到我们最近完成的初步试验 (R21AG056584) 取得了令人鼓舞的结果。该研究的其他目标是使用混合方法检查 ART 后认知评估的变化和损失的整合方法并评估反应的个人、社会和心理因素预测因素。在拟议的双盲、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 或教育计划时间和注意力相匹配。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/注册 (T1) 时、4 次会议结束时进行干预期（T2）以及丧亲后 6 个月（T3）和 12 个月（T4）。小组20人随机分配到 ART 的参与者将参加半结构化访谈以增强理解认知评估和损失整合。该试验将提供关于 ART 干预作为潜在一线治疗的功效的关键信息损失前悲伤的选项和复杂悲伤的预防选项，并提供有关的新信息最有可能从 ART 中受益的个人的特征。