Mindfulness Training: the Effects of a Stress Reduction Program on Older Portuguese-speaking People in Luxembourg

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness Training in Aging: the Effects of a Stress Reduction Program on Portuguese-speaking People Aged Fifty-five and Over Residing in Luxembourg

Conditions
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Mindfulness, Healthy Aging

Intervention / Treatment
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* Behavioral: MBSR
* Behavioral: HPP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based stress reduction - MBSR<br>Traditional MBSR curriculum | Behavioral: MBSR<br>* The MBSR is an eight-week group-based psychoeducational program. It is performed in weekly group sessions with the duration of 2.5 hours and a half-day retreat of 4 hours. The program involves focused attention, consisting of body scan, yoga, and meditation. This program trains participants to be attentive to their thoughts, emotions, and sensations. There are also discussions on relevant topics related to the physiology of stress and strategies of coping. Materials for home practice are provided.<br>|
| Active Comparator: Health Promotion Program - HPP<br>the HPP has the same structure of MBSR, but training different components, not including mindfulness practice. | Behavioral: HPP<br>* The HPP has the same structure of MBSR, including different components such as music, nutrition, cognitive enhancement, risk factors for dementia, and physical activity. During the half-day retreat participants are involved in watercolor painting activities. Materials for home practice are also provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in executive functioning comparing the two groups over time | Assessed by the Trail Making Test | T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention | 
| Changes in executive functioning comparing the two groups over time | Assessed by the Stroop Test | T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention | 
| Changes in executive functioning comparing the two groups over time | Assessed by the Letter-number sequencing from WAIS-III | T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cortisol levels comparing the two groups over time | assessed by collecting saliva at baseline and post-intervention | T1- baseline before the intervention; T2 - 8 weeks after baseline | 
| Qualitative interview comparing the two groups over time | Interview asking about the program challenges and benefits | 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 | The Mindfulness Attention and Awareness Scale (MAAS) | 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. | 
| Change in stress levels comparing the two groups over time | Assessed by the Perceived Stress Scale | 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 | Heart rate variability | 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 | Pittsburgh sleep quality index | 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 | Mini-Mental State Questionnaire | 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 | Geriatric Anxiety Inventory (GAI) | T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention |