Mindfulness Training in Aging: the Effects of a Stress Reduction Program on Portuguese-speaking People Aged Fifty-five and Over Residing in Luxembourg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Changes in executive functioning comparing the two groups over time
研究概览
简要总结
This project aims to investigate the MBSR feasibility and its effects in old Portuguese-speaking adults living in Luxemburg.
This study will be a two-arm randomized-double blinded-controlled study, including 90 healthy older adults. The MBSR will be conducted in groups over a total of eight weeks, incorporating weekly meetings, a retreat of 4 hours, and extra activities to be practiced at home. The active control condition will be a program with different components such as painting, nutrition information, physical activity, cognitive enhancement, risk factors for dementia, and health promotion. Neuropsychological assessments will be conducted at baseline, immediately after and one-month post-intervention. The researchers will also do pre-post salivary cortisol and resting heart rate variability analyses, as surrogate measures to assess stress level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Portuguese-speaker Migrants over 55 years old, residing in the Grand-Duchy of Luxembourg the Greater Region;
- •Mastery of written and spoken Portuguese;
- •Subjects without cognitive impairment (The Mini Mental State Examination - MMSE, cut-off of < 22 will be adopted since most of participants are expected to have low education level -Kochhann et al, 2010)
- •Subjects with a full capacity of consent.
排除标准
- •Previous (up to 2 years before) or actual weekly participation in formal meditation, yoga or mindfulness-based interventions
- •Concomitant participation in other kind of enhancement intervention in group, e.g., cognitive training, psychological therapy
- •Severe hearing or visual impairment (not corrected)
- •Severe medical condition requiring intensive medical care that makes it difficult to participate in the group sessions
- •Refusal to sign the informed consent
- •Diagnosis of dementia
- •Clinical neurodegenerative illness, psychotic disorder, unstable psychiatric condition which makes it difficult to participate in groups, posttraumatic stress disorder or history of trauma, individuals with acute psychosis, mania, suicidality or alcohol chronic or other substance abuse within the last 6 months (cutoff: 2 points at the Adult DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure)
研究组 & 干预措施
Mindfulness-based stress reduction - MBSR
Traditional MBSR curriculum
干预措施: MBSR (Behavioral)
Health Promotion Program - HPP
the HPP has the same structure of MBSR, but training different components, not including mindfulness practice.
干预措施: HPP (Behavioral)
结局指标
主要结局
Changes in executive functioning comparing the two groups over time
时间窗: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
Assessed by the Trail Making Test
次要结局
- Qualitative interview comparing the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention)
- Changes in humor between the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention)
- Changes in the dispositional mindfulness comparing the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention. Minimum value: 15. Maximum value: 90. Higher scores reflect greater mindfulness.)
- Changes in cortisol levels comparing the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline)
- Change in stress levels comparing the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention. Minimum value: 0. Maximum value: 40. Higher scores reflect greater perceived stress.)
- Change in the heart rate assessment comparing the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention)
- Change in sleep quality comparing the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention)
- Changes in general cognition comparing the two groups over time(T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention)