Caring for the Family Caregiver: Testing the Effect of Two Wellness Programs That Support the Well-being of Family Caregivers of Persons With Neurodegenerative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Center for Epidemiological Studies - Depression
研究概览
简要总结
The purpose of this study is to assess whether an 8-week mindfulness program enhances psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability) in primary family caregivers of persons with dementia or a related neurodegenerative disease. A total of 232 primary family caregivers aged 50+ years of age will be recruited for this study and randomized to one of three groups: mindfulness meditation (MM), psychoeducation (PSY) or caregiver respite (CR). All participants will complete three testing sessions: baseline (pre-intervention [T1]), post 8-week follow-up (post-intervention, [T2]), and 12-month follow-up (T3).
详细描述
The purpose of this study is to assess the benefits of 2 virtual self-care programs - mindfulness meditation or a psychoeducation support group - for family caregivers of persons with a neurodegenerative disorder. Both programs are 8-weeks in length. A third arm will include a respite-ony group, which may be considered "treatment as usual". Outcomes of interest include psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability). All participants will complete three testing sessions: baseline (pre-intervention [T1]), post 8-week follow-up (post-intervention, [T2]), and 12-month follow-up (T3). The target sample is 232 family/informal caregivers, aged 50+ years old. All sessions will be conducted using the Zoom platform. Participants will be required to go to LifeLabs for blood collection. Blood results will be shared with participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researchers who engage in pre-post testing assessment will be blinded to participant allocation.
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50+ years of age
- •Currently a primary family caregiver
- •Fluent in English
排除标准
- •Existing mindfulness practice
- •Diagnosed/Presenting with Post-traumatic Stress Disorder; Substance Disorder; Psychosis
- •Unable to attend 8 sessions
- •No access to a computer or high-speed internet
- •Not willing to be randomized
结局指标
主要结局
Center for Epidemiological Studies - Depression
时间窗: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
A 20-item Likert-type questionnaire that measures presence of depressive symptoms in the past week. Higher scores (range 0-60) indicate greater depressive symptoms.
Perceived Stress Scale
时间窗: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
10-item Likert-type scale that measured level of distress in the past month. The questionnaire will be modified to cover the past 2 weeks. Higher scores (range 0-40) indicate greater perceived stress.
次要结局
- Zarit Burden Interview(Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.)
- Allostatic Load Index(Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up)
- Flanker Task(Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.)
研究者
Alexandra J. Fiocco, PhD
Professor
Toronto Metropolitan University