Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.
Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America.
Contemp Clin Trials. 2022 Dec;123:106998. doi: 10.1016/j.cct.2022.106998. Epub 2022 Nov 8.
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.
患有急性神经系统疾病（ANI；例如中风、肿瘤、TBI）的患者和他们的非专业照顾者被收入神经重症监护病房（Neuro-ICU）后，焦虑、抑郁和创伤后应激的发生率很高。为满足这一需求，我们之前开发了 Recovering Together（RT）双干预措施，以帮助预防患者和照顾者的慢性情绪困扰。目前，我们正在进行一项全面、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 RCT 的方案和现状。
我们的目标是从 MGH 的 Neuro-ICU 招募 194 对处于风险中的患者-照顾者二人组。符合条件的二人组包括被诊断为 ANI 的患者，认知完整，至少有一位伴侣表示情绪困扰（在医院焦虑和抑郁量表上），英语流利，年龄在 18 岁或以上。二人组随机分配到干预组（RT-1）或对照组（RT-2）（均为六次疗程）。RT-1 教授韧性（例如应对、正念）和人际交往技巧。RT-2 提供有关健康相关主题的教育（例如压力、自我保健、遵守医疗建议）。盲法研究助理在基线、干预后和三个月随访时收集测量数据。我们将进行混合线性、中介和演员-伙伴相互依存模型，以检验随时间变化的二人组结果的变化。
我们已经招募了 41 对二人组，目标是总共招募 194 对。
如果成功，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-实施研究中测试 RT。增强患者和家庭的社会心理支持可以改善健康结果、医疗保健效率和这些单位的文化。
