Effectiveness of an Online Mindfulness Program for Stroke Survivors and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Mindfulness is promising for individuals with neurological disorders and caregivers to improve psychological well-being. This study aims to determine the extent to which a 3-week online mindfulness intervention will improve quality of life and psychological well-being for chronic stroke survivors and their caregivers, compared to a waitlist control.
详细描述
Background: The incidence of depression and anxiety is much higher in stroke survivors and their caregivers compared to age-matched peers. Previous work suggests that mindfulness delivered in an online format is promising for both individuals with neurological disorders and caregivers to improve quality of life and psychological well-being.
Aim: This project aims to determine the extent to which a 3-week online mindfulness intervention will improve quality of life and psychological well-being for chronic stroke survivors and their caregivers, compared to a waitlist control. The primary hypothesis is that participants in the mindfulness group will demonstrate greater improvement in quality of life and psychological well-being post-intervention compared to waitlist control participants. The secondary hypothesis is that these improvements will persist for at least 1-month post-intervention.
Methods: This project uses a pragmatic, randomized, waitlist-control trial design with blinded outcome assessment. Participants (stroke survivors and caregivers) are assigned to a 3-week online mindfulness intervention, or a 2-month delayed waitlist. A battery of self-reported outcome measures and clinical tests are administered pre-intervention, post-intervention and at 1-month follow-up. Participants in the waitlist control group are also assessed at enrollment. A sample of 44 stroke survivors and 44 caregivers is targeted. Changes will be measured using a repeated analysis of variance.
Conclusion: The study constitutes the initial step to understand the role of mindfulness exercises delivered remotely and the potential benefit of the intervention for stroke survivors across a wide range of disability level and their caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcome measures are self-reported measures administered via online surveys, except for one. The person performing the data analysis will be blinded to group allocation.
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
- •Stroke survivor or caregiver of someone who have had a stroke
- •Fluent in English
- •Have access to Internet using a computer, a tablet and/or a smart phone.
排除标准
- •Severe language impairments
- •Participation in regular meditation or a mindfulness program in past 3 months
研究组 & 干预措施
Stroke survivors - Mindfulness intervention
Participants who have had a stroke who are receiving the mindfulness intervention immediately after enrollment (no wait period).
干预措施: Langerian mindfulness (Behavioral)
Stroke survivors - Waitlist control
Participants who have had a stroke who are assigned to the waitlist.
Caregivers - Mindfulness intervention
Participants caring for someone who have had a stroke and receiving the mindfulness intervention immediately after enrollment (no wait period).
干预措施: Langerian mindfulness (Behavioral)
Caregivers - Waitlist control
Participants caring for someone who have had a stroke assigned to the waitlist.
结局指标
主要结局
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
时间窗: 2 months
The HADS assesses depression and anxiety. It is a 14-item scale with 7 items each for anxiety and depression subscales. Each item is scored from 0 to 3, with higher scores indicating higher anxiety or depressive symptoms.
Change from baseline on Single-item Sleep Quality Scale (SQS)
时间窗: 2 months
The SQS assesses sleep quality and includes an 11-point visual analogue scale about sleep quality in the past week (0: poor, 10: excellent sleep quality).
Change from baseline on NIH Toolbox Perceived Stress Survey (PSS)
时间窗: 2 months
The PSS assesses perceived stress. It includes 10 items about the occurrence of life stressors scored from 0 (never) to 4 (very often). Higher scores indicate higher perceived stress.
次要结局
- Change from baseline on Stroke-specific Quality of Life (SS-QOL)(2 months)
- Change from baseline on Zarit Burden Interview(2 months)
- change in the modified Ashworth Scale (elbow)(2 months)
- Change from baseline on World Health Organization Quality of Life-BREF (WHOQOL-BREF)(2 months)
研究者
Carolee Winstein
Professor
University of Southern California