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
- 1
- 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
研究组 & 干预措施
Mindfulness Meditation (MM)
8-week mindfulness meditation program is based on Kabat-Zinn's MBSR program and will be led by MBSR-trained facilitators. The program has been modified to make it more accessible to caregivers. Weekly sessions will be 120-minutes long (instead of original 150-180-minute sessions). Formal meditation practices described in the original MBSR program (i.e., body scan, sitting meditation, mindful movement, mindful eating and walking) will be taught, in addition to loving kindness meditation (LKM). Participants will be given guided meditation recordings and compliance with home practice will be monitored with a practice log. The prescribed home practice has been modified to accommodate the needs of the caregiver: each practice is offered in 5- to 10-minute intervals (5 min, 10 min, and 20 min practice) to accommodate the caregiver's schedule.
干预措施: Mindfulness Meditation (Other)
Psychoeducation
Psychoeducation (PSY) condition will be similar to MM with respect to number and duration of weekly sessions and daily homework. PSY is a lecture-based program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. Each session focuses on a specific topic related to wellness (e.g., nutrition, physical activity, medical screening) and caregiver-specific topics (e.g., understanding dementia and neurodegenerative disease, legal and financial issues).
干预措施: Psychoeducation (Other)
Respite control
Participant allocated to RC will not be exposed to a program, but will be offered 120-minutes of weekly respite care. Caregivers will be asked to record how they spend respite hours each week.
干预措施: Wait list control (Other)
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