心脏骤停幸存者及其非正式照顾者情绪困扰的身心恢复干预-心脏骤停后一起恢复：开放试点试验方案。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-01 DOI:10.1016/j.conctc.2024.101426

Danielle La Camera , Jonathan Elmer , Sarah M. Perman , Michael W. Donnino , Ona Wu , Robert A. Parker , Ana-Maria Vranceanu , Alexander M. Presciutti

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引用次数: 0

摘要

背景：慢性情绪困扰在心脏骤停（CA）幸存者及其照顾者中普遍存在，并恶化了生活质量和康复。预防ca后慢性痛苦的干预措施是必要的。我们开发了心脏骤停后一起恢复（RT-CA），这是一种增加心脏骤停幸存者-照顾者二人组（对）恢复能力的干预措施。方法：我们将开展一项开放式的RT-CA临床先导试验，初步探讨干预的可行性，并根据参与者的反馈完善干预措施。我们将在单个学术医疗中心招募至少7名CA幸存者-护理者二人组。我们将通过筛选入院报告和通过医务人员的转介来确定合格的幸存者。纳入标准：幸存者-有足够的认知状态以有意义地参与（迷你精神状态测试简短形式≥5）。Dyads -说英语的人；一名成员必须有临床显著的痛苦（在医院焦虑和抑郁量表中的任何一个分量表中均≥8）。程序：二人将与临床医生一起参加6次30-45分钟的会议。会议将包括身心应对技能培训和提供预期指导和资源，以导航ca幸存者。二人将完成测试前和测试后的情绪困扰测量和治疗目标。我们将计算主要结果的频率和比例（可行性——招募、评估、依从性、治疗师忠实度和可接受性/可信度）。在完成测试后的评估后，双方将通过离职面谈提供反馈。我们将使用解释-序列混合方法整合定性和定量数据。讨论：我们将利用我们的发现来完善RT-CA的内容和研究程序。如果成功，RT-CA有可能显著提高CA幸存者及其护理人员的生存质量。

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A mind-body resilience intervention for emotional distress in cardiac arrest survivors and their informal caregivers – Recovering together after cardiac arrest: Protocol for an open pilot trial

Background

Chronic emotional distress among cardiac arrest (CA) survivors and their caregivers is prevalent and worsens quality of life and recovery. Interventions to prevent chronic distress post-CA are needed. We developed Recovering Together after Cardiac Arrest (RT-CA), an intervention to increase resiliency in CA survivor-caregiver dyads (pairs).

Method

We will conduct an open pilot clinical trial of RT-CA to examine preliminary feasibility and refine the intervention based on participant feedback. We will enroll at least 7 CA survivor-caregiver dyads during their hospitalization at a single academic medical center. We will identify eligible survivors by screening admission reports and through referrals from medical staff. Inclusion criteria: Survivors - sufficient cognitive status to meaningfully participate (Short Form of the Mini Mental State Exam ≥5). Dyads - English-speakers; one member must have clinically significant distress (≥8 on either Hospital Anxiety and Depression Scale subscale). Procedure: dyads will participate in 6, 30–45 min sessions with a study clinician. Sessions will include mind-body coping skills training and provision of anticipatory guidance and resources to navigate CA-survivorship. Dyads will complete pre- and post-test measures of emotional distress and treatment targets. We will calculate frequencies and proportions of our primary outcomes (feasibility - recruitment, assessments, adherence, therapist fidelity and acceptability/credibility). After completing post-test assessments, dyads will provide feedback via exit interviews. We will integrate qualitative and quantitative data using explanatory-sequential mixed-methods.

Discussion

We will use our findings to refine RT-CA content and study procedures. If successful, RT-CA has potential to significantly improve quality of survivorship for CA survivors and their caregivers.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.