Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial
Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial
批准号:
10578937
负责人:
Cindy Tofthagen
金额:
$67.28万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-03-15 至 2028-02-29
关键词:
AccelerationAcuteAddressAgingAssessment toolAttentionBereavementCaregiver BurdenCaregiversCessation of lifeCharacteristicsChronic DiseaseChronic stressClinical TrialsCognitiveDataData CollectionDistressDouble-Blind MethodEarly InterventionEarly treatmentEducationElderlyEmotionalEnrollmentEquipment and supply inventoriesEventEvidence based treatmentFamilyFamily CaregiverFamily memberFriendsFutureGeographic LocationsGoalsGrief reactionHealthHobbiesIndividualInterventionInterviewLifeMental DepressionMethodsMorbidity - disease rateOutcomePalliative CareParticipantPersonsPhysical FunctionPragmatic clinical trialPreventionProcessPsychological FactorsPsychotherapyQuality of lifeRandomizedRecoveryResearchResolutionResourcesRiskScienceSocial supportStressStructureSubgroupSymptomsTestingTherapeutic InterventionTimeTraumaVeteransWaiting Listsacute stressadvanced diseasearmattentional controlbiological adaptation to stressbrief interventioncognitive processcopingeffective interventionefficacy evaluationefficacy testingexperienceimmune functionimprovedinstrumentloved onesmental functionmortalitypredicting responsepreventpreventive interventionprimary outcomeprogramspsychologicrandomized, clinical trialsresponsescreeningsocialsocial factorsstress related disordersuccesstime usetraumatic eventtreatment as usualtreatment response
中文摘要
项目摘要/摘要
适应不良的悲痛对25%-40%的严重慢性病患者的老年人家庭照顾者产生负面影响
疾病,有不良的健康后果,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与衰老有关的损失,如多个近亲的死亡和
朋友,是高度创伤的,并对老年人适应不良悲伤的破坏性影响做出贡献
成年人。8、10在悲伤轨迹的早期对适应不良的悲伤进行简短、有效的干预是迫切的
需要的。
加速解决疗法(ART)是一种针对平民创伤后痛苦的循证治疗
和退伍军人14-17,这可能有助于减轻丧亲前的适应不良悲痛,并可以防止
在失去亲人之后漫长而复杂的悲痛。我们建议测试抗逆转录病毒疗法的疗效,这是一种低风险、
简短的治疗,具有治疗适应不良悲痛成功的强有力的理论基础,并得到
我们最近完成的初步试验(R21AG056584)取得了可喜的结果。该研究的其他目标包括
用混合方法考察ART后的认知评估和整合的变化
并评估个人、社会和心理因素对反应的预测作用。
在拟议的双盲、随机、对照双臂临床试验期间,472个老年家庭
来自两个不同地理位置的照顾者将接受艺术或教育计划,
在时间和注意力上都不相上下。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/登记(T1)时进行,在4节课程结束时进行
干预期(T2)、丧亲后6个月(T3)和12个月(T4)。由20人组成的小组
随机分配到ART的参与者将参加半结构化访谈以增进理解
认知评估和损失整合。
这项试验将提供有关ART干预作为潜在一线治疗的疗效的关键信息。
针对损失前悲伤的选项和针对复杂悲伤的预防性选项,并提供有关
最有可能从艺术中受益的个人的特征。
英文摘要
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.
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