Recovering Together: Building Resiliency in Dyads of Patients With an Acute Brain Injury Admitted to the Neuroscience Intensive Care Unit and Their Informal Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Change in Emotional Distress
研究概览
简要总结
The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.
详细描述
The goals of this study are to: 1) demonstrate the efficacy of Recovering Together for improving self-reported emotional distress (primary outcome), and post traumatic stress, mindfulness, coping, social support and other relevant outcomes (secondary outcomes); and 2) assess mechanisms (mediators and moderators) of improvement after intervention. We will enroll and randomly assign 194 at risk dyads (97 per study group) to receive either the active intervention or educational control. The trial is single blinded (assessors, patients and staff). The trial will take place at the Massachusetts General Hospital NICU using our established methodology successfully implemented during the R21 pilot study. Study clinicians will deliver 6, 30 minute sessions of active intervention or educational control (2 at bedside and 4 via live video after discharge) to each patient-caregiver dyad. All participants will complete measures at baseline, after completion of program (6 weeks) and 3 months later. They will also complete measures of emotional distress weekly, as well as measures assessing home practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •English fluency and literacy
- •Patient with an informal caregiver available and willing to participate
- •Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI
- •Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)
排除标准
- •Permanent cognitive impairment (including severe hearing impairment) or aphasia that makes participation impossible
- •Short form of Mini-Mental State Exam (SMMSE) score <4 (If SMMSE <4, nursing team decides whether or not the patient can meaningfully participate)
- •Glasgow Coma Scale (GCS) score <10
- •Terminal diagnosis
- •Lack of access to internet and/or a device with a camera
- •Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
研究组 & 干预措施
Experimental Patient-Caregiver Dyads
There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily skills.
干预措施: Recovering Together (Behavioral)
Control Patient-Caregiver Dyads
There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily educational.
干预措施: Recovering Together (Behavioral)
结局指标
主要结局
Change in Emotional Distress
时间窗: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months
Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression
次要结局
- Change in Interpersonal Factors (perceived social support)(0 weeks, 6 weeks, 3 months)
- Change in Resiliency Factors (Mindfulness - curiosity and de-centering)(0 weeks, 6 weeks, 3 months)
- Change in Resiliency Factors (Mindfulness)(0 weeks, 6 weeks, 3 months)
- Change in Resiliency Factors (Individual Coping)(0 weeks, 6 weeks, 3 months)
- Change in Resiliency Factors (Dyadic Coping)(0 weeks, 6 weeks, 3 months)
- Change in Interpersonal Factors (avoidant or anxious communication)(0 weeks, 6 weeks, 3 months)
- Change in Post-Traumatic Stress(0 weeks, 6 weeks, 3 months)
- Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions)(0 weeks, 6 weeks, 3 months)
研究者
Ana-Maria Vranceanu, PhD
Associate Professor/Director
Massachusetts General Hospital