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

Healthy Aging Clinical Trial

— MEDITAGING  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615337
• Other study ID #: ULuxembourg
• Status: Completed
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: University of Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Aging
• Mindfulness

Intervention

Behavioral:
• MBSR
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.
• HPP
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.

Locations

Country	Name	City	State
Luxembourg	University of Luxembourg	Luxembourg	Other

Sponsors (2)

Lead Sponsor	Collaborator
University of Luxembourg	Luxembourg National Research Fund (FNR)

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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