Clinical trial NCT05615337: Mindfulness Training: the Effects of a Stress Reduction Program on Older Portuguese-speaking People in Luxembourg
Official title: Mindfulness Training in Aging: the Effects of a Stress Reduction Program on Portuguese-speaking People Aged Fifty-five and Over Residing in Luxembourg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Healthy Aging
Lead sponsor: University of Luxembourg
Sponsor class: OTHER
Collaborators: name: Luxembourg National Research Fund (FNR)
First posted: 2022-11-14
Enrollment: 89
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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)

Primary outcomes:
measure: Changes in executive functioning comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
measure: Changes in executive functioning comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
measure: Changes in executive functioning comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
Secondary outcomes:
measure: Changes in cortisol levels comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline
measure: Qualitative interview comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
measure: Changes in the dispositional mindfulness comparing the two groups over time
timeFrame: 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.
measure: Change in stress levels comparing the two groups over time
timeFrame: 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.
measure: Change in the heart rate assessment comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
measure: Change in sleep quality comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
measure: Changes in general cognition comparing the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
measure: Changes in humor between the two groups over time
timeFrame: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: University of Luxembourg
state: Other
Study officials:
affiliation: University of Luxembourg
name: Anja Leist, PhD
role: PRINCIPAL_INVESTIGATOR
References: