背景:严重急性脑损伤(SABI)导致昏迷并需要重症监护病房(ICU)治疗的患者的照顾者通常会经历慢性情绪困扰。为了满足这一需求,我们开发了昏迷家族(COMA-F)计划,对这些护理人员进行基于正念的弹性干预。
目的:我们将进行COMA-F(美国国立卫生研究院IA期)的公开试点试验。在这里,我们描述了我们的研究方案和提出的干预内容。
方法:我们将在3个登记中心招募15名SABI患者的看护人员。临床心理学家将通过Zoom(ZoomVideoCommunications,公司)或亲自。在每个护理人员完成干预和离职面谈后,我们将迭代COMA-F。具有经临床团队确认的情绪困扰并且是SABI患者的主要照顾者的讲英语的成年人符合资格。成年患者必须因SABI进入神经ICU,并且(1)格拉斯哥昏迷评分低于9,但未插管或由于SABI在住院期间的任何时间点插管>24小时无法遵循有意义的命令;(2)将接受气管造口术或经皮内窥镜或外科胃造瘘管置入术或已经接受了一个或两个;(3)生存时间>3个月。我们将通过筛查患者的医疗记录和神经ICU临床医生的直接转诊来确定合格的护理人员。在干预期间,我们将教授护理人员身心和复原能力,包括深呼吸,正念,冥想,辩证思维,接受,认知重组,有效沟通,行为激活,和意义制造。照顾者将在干预前后完成自我报告评估(情绪困扰和韧性的措施)。主要结果是可行性(招募,定量措施,坚持,和治疗师忠诚)和可接受性(治疗满意度,信誉,和预期)。我们将进行简短的定性退出面试,以收集有关完善计划和研究程序的反馈。我们将检查频率和比例,以确定可行性和可接受性,并将使用主题分析来分析定性退出面试数据。我们还将进行双尾t测试,以探索情绪困扰和治疗目标改善的信号。然后,我们将进行解释顺序混合方法分析,以整合定量和定性数据,以完善COMA-F手册和研究程序。
结果:本研究已在3个注册中心(2023P000536)中的1个获得机构审查委员会的批准,其他两个中心的批准待定。我们预计这项研究将于2024年底完成。
结论:我们将利用我们的发现来完善COMA-F干预措施,并为可行性随机对照试验做准备。
背景:ClinicalTrials.govNCT05761925;https://clinicaltrials.gov/study/NCT05761925。
■PRR1-10.2196/50860。
BACKGROUND: Caregivers of patients with severe acute brain injuries (SABI) that lead to coma and require intensive care unit (ICU) treatment often experience chronic emotional distress. To address this need, we developed the Coma Family (COMA-F) program, a mindfulness-based resiliency intervention for these caregivers.
OBJECTIVE: We will conduct an open pilot trial of COMA-F (National Institutes of Health Stage IA). Here we describe our study protocol and proposed intervention content.
METHODS: We will enroll 15 caregivers of patients with SABIs during their loved one\'s hospital course from 3 enrollment centers. A clinical psychologist will deliver the COMA-F intervention (6 sessions) over Zoom (Zoom Video Communications, Inc) or in person. We will iterate COMA-F after each caregiver completes the intervention and an exit interview. English-speaking adults who have emotional distress confirmed by the clinical team and are the primary caregivers of a patient with SABI are eligible. The adult patient must have been admitted to the neuro-ICU for SABI and (1) have had a Glasgow Coma Scale score below 9 while not intubated or an inability to follow meaningful commands while intubated at any point during their hospitalization for >24 hours due to SABI; (2) will be undergoing either tracheostomy or percutaneous endoscopic or surgical gastrostomy tube placement or have already received one or both; and (3) have a prognosis of survival >3 months. We will identify eligible caregivers through screening patients\' medical records and through direct referrals from clinicians in the neuro-ICU. During the intervention we will teach caregivers mind-body and resilience skills, including deep breathing, mindfulness, meditation, dialectical thinking, acceptance, cognitive restructuring, effective communication, behavioral activation, and meaning-making. Caregivers will complete self-report assessments (measures of emotional distress and resilience) before and after the intervention. Primary outcomes are feasibility (recruitment, quantitative measures, adherence, and therapist fidelity) and acceptability (treatment satisfaction, credibility, and expectancy). We will conduct brief qualitative exit interviews to gather feedback on refining the program and study procedures. We will examine frequencies and proportions to determine feasibility and acceptability and will analyze qualitative exit interview data using thematic analysis. We will also conduct 2-tailed t tests to explore signals of improvement in emotional distress and treatment targets. We will then conduct an explanatory-sequential mixed methods analysis to integrate quantitative and qualitative data to refine the COMA-F manual and study procedures.
RESULTS: This study has been approved by the institutional review board at 1 of the 3 enrollment centers (2023P000536), with approvals at the other 2 centers pending. We anticipate that the study will be completed by late 2024.
CONCLUSIONS: We will use our findings to refine the COMA-F intervention and prepare for a feasibility randomized controlled trial.
BACKGROUND: ClinicalTrials.gov NCT05761925; https://clinicaltrials.gov/study/NCT05761925.
UNASSIGNED: PRR1-10.2196/50860.