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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging; Mindfulness
• Intervention / Treatment: Behavioral: MBSR; Behavioral: HPP

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Luxembourg
  • Other
    • Luxembourg, Other, Luxembourg, 4700-154
      • University of Luxembourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based stress reduction - MBSR; Traditional MBSR curriculum	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.
Active Comparator: Health Promotion Program - HPP; the HPP has the same structure of MBSR, but training different components, not including mindfulness practice.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Luxembourg
• Collaborators: Luxembourg National Research Fund (FNR)
• Investigators: Principal Investigator: Anja Leist, PhD, University of Luxembourg

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ULuxembourg

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No