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

Not Applicable

Completed

• Conditions: Mindfulness; Healthy Aging
• Interventions: Behavioral: HPP; Behavioral: MBSR

• Registration Number: NCT05615337
• Lead Sponsor: University of Luxembourg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-26
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-14
• Status Verified: 2023-05
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Promotion Program - HPP	HPP	the HPP has the same structure of MBSR, but training different components, not including mindfulness practice.
Mindfulness-based stress reduction - MBSR	MBSR	Traditional MBSR curriculum

Primary Outcome Measures

Name	Time	Method
Changes in executive functioning comparing the two groups over time	T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention	Assessed by the Letter-number sequencing from WAIS-III

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Luxembourg; 🇱🇺 Luxembourg, Other, Luxembourg