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Recruiting
NCT05615337
Mindfulness Training: the Effects of a Stress Reduction Program on Older Portuguese-speaking People in Luxembourg
Conditions: Mindfulness, Healthy Aging
Sex: All
Ages: 55 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: University of Luxembourg
Location: Luxembourg
Summary
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.
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria:Previous (up to 2 years before) or actual weekly participation in formal meditation, yoga or mindfulness-based interventionsConcomitant participation in other kind of enhancement intervention in group, e.g., cognitive training, psychological therapySevere hearing or visual impairment (not corrected)Severe medical condition requiring intensive medical care that makes it difficult to participate in the group sessionsRefusal to sign the informed consentDiagnosis of dementiaClinical 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)
Source: ClinicalTrials.gov (NCT05615337). StuddyBuddy aggregates publicly available trial information.