Addressing Emotional Distress in Dyads of Persons With a Young Onset Dementia (YOD) and Their Care-partners
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 virtual, brief (6 sessions) dyadic (patient and care-partner together) intervention to prevent chronic emotional distress in dyads where one person is diagnosed with Young Onset Dementia (YOD). Through this study, we seek to address the unmet need of preventing chronic emotional distress in YOD dyads through a feasible, acceptable and credible program, and ideally enhance resiliency and improve wellbeing and quality of life in both members of the dyad.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-65 at the time of enrollment [both patient and care-partner]
- •Diagnosis of young-onset dementia (FTD, PPA, AD, PCA, etc.) with symptom onset prior to age 65 [patient]
- •A designated care-partner willing and interested to participate [both patient and care-partner]
- •Received YOD diagnosis in the past 6 month [patient]
- •English fluency and literacy [both patient and care-partner]
- •Cognitive ability to understand study and research protocol in order to consent to study participation per referring neurologist [both patient and care-partner]
- •Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)
排除标准
- •An additional, terminal diagnosis such as cancer
- •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: Experimental Patient-Caregiver Dyads
There will be 6 sessions delivered via live video using Zoom. Content will be primarily skills.
干预措施: Resilient Together-YOD (Behavioral)
Control Patient-Caregiver Dyads
There will be 6 sessions delivered via live video using Zoom. Content will be primarily educational.
干预措施: Health Enhancement Program-YOD (Behavioral)
结局指标
主要结局
Change in Emotional Distress
时间窗: 0 weeks, 6 weeks, 12 weeks
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 Resiliency Factors (Mindfulness)(0 weeks, 6 weeks, 12 weeks)
- Change in Resiliency Factors (Individual Coping)(0 week, 6 weeks, 12 weeks)
- Change in Resiliency Factors (Mindfulness Utilization)(0 weeks, 6 weeks, 12 weeks)
- Changes in Interpersonal Factors (Dyad Coping)(0 weeks, 6 weeks, 12 weeks)
- Changes in Resiliency Factors (Perceived Social Support)(0 weeks, 6 weeks, 12 weeks)
- Changes in Resiliency Factors (Values-based Living)(0 weeks, 6 weeks, 12 weeks)
研究者
Ana-Maria Vranceanu, PhD
Full Professor/Director
Massachusetts General Hospital