The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU.
The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU.
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DOI：
10.1016/j.cct.2022.106998
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发表时间：
2022-12
影响因子：
2.2
通讯作者：
Grunberg, Victoria A.
中科院分区：
文献类型：
--
作者：
Vranceanu, Ana-Maria;Woodworth, Emily C.;Kanaya, Millan R.;Bannon, Sarah;Mace, Ryan A.;Manglani, Heena;Duarte, Brooke A.;Rush, Christina L.;Choukas, Nathaniel R.;Briskin, Ellie A.;Cohen, Joshua;Parker, Robert;Macklin, Eric;Lester, Ethan;Traeger, Lara;Rosand, Jonathan;Grunberg, Victoria A.
关键词：
患有急性神经系统疾病（ANI;例如，中风、肿瘤、TBI）及其非正式照顾者经历焦虑、抑郁和创伤后应激的比例很高。为了满足这一需求，我们以前开发了恢复在一起（RT）的二元干预，以帮助防止慢性情绪困扰的患者和照顾者。目前，我们正在进行一项充分的，单盲随机临床试验（RCT），以评估RT与注意力匹配的健康教育对照的疗效。在这里，我们描述了该随机对照试验的方案和现状。我们的目标是从MGH的神经ICU招募194名有风险的患者-护理人员配对。符合条件的二人组包括诊断为ANI的患者，认知功能完整，至少有一名伴侣认可情绪困扰（医院焦虑和抑郁量表），讲英语，年龄18岁或以上。将二人组随机分为干预组（RT-1）或对照组（RT-2）（均为6个阶段）。RT-1教导了弹性（例如，应对，正念）和人际交往技能。RT-2提供有关健康相关主题的教育（例如，压力，自我护理，坚持医疗建议）。盲态研究助理在基线、干预后和三个月随访时收集测量结果。我们将进行混合线性，中介，和演员-合作伙伴相互依存模型，以检查随着时间的推移，在二人组的结果的变化。我们已经招募了41对，目标是招募194个。如果成功的话，我们计划在全国范围内的神经重症监护病房进行大规模、多地点的混合有效性实施研究。加强对患者和家属的心理支持可以改善健康状况，提高医疗效率和这些单位的文化。
Patients admitted to the Neuroscience Intensive Care Unit (Neuro-ICU) with acute neurological illnesses (ANI; e.g., stroke, tumor, TBI) and their informal caregivers experience high rates of anxiety, depression, and posttraumatic stress. To address this need, we previously developed the Recovering Together (RT) dyadic intervention to help prevent chronic emotional distress in both patients and caregivers. Currently, we are conducting a fully-powered, single-blind randomized clinical trial (RCT) to evaluate the efficacy of RT versus an attention matched health education control. Here, we describe the protocol and current status of this RCT. We aim to recruit 194 at risk patient-caregiver dyads from the Neuro-ICU at MGH. Eligible dyads include patients diagnosed with ANI, cognitively intact, at least one partner endorses emotional distress (on Hospital Anxiety and Depression Scale), English speaking, age 18 or older. Dyads are randomized to the intervention (RT-1) or control condition (RT-2) (both six sessions). RT-1 teaches resiliency (e.g., coping, mindfulness) and interpersonal skills. RT-2 provides education on health-related topics (e.g., stress, self-care, adhering to medical recommendations). Blinded research assistants collect measures at baseline, post-intervention, and three months follow-up. We will conduct mixed linear, mediation, and actor-partner interdependence models to examine changes in dyads’ outcomes across time. We have recruited 41 dyads and aim to recruit 194 total. If successful, we plan to test RT in a large-scale, multisite hybrid effectiveness-implementation study in Neuro-ICUs across the country. Enhancing psychosocial supports for patients and families could improve health outcomes, healthcare efficiency, and the culture of these units.
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