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

NCT ID: NCT05615337

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2023-08-31

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.

Conditions

Mindfulness; Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness-based stress reduction - MBSR

Traditional MBSR curriculum

Group Type: EXPERIMENTAL

MBSR

Intervention Type: BEHAVIORAL

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.

Health Promotion Program - HPP

the HPP has the same structure of MBSR, but training different components, not including mindfulness practice.

Group Type: ACTIVE_COMPARATOR

HPP

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Luxembourg National Research Fund (FNR)

UNKNOWN

Sponsor Role: collaborator

University of Luxembourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anja Leist, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Luxembourg

Locations

University of Luxembourg

Luxembourg, Other, Luxembourg

Countries

Luxembourg

References

Teixeira-Santos AC, Gomes L, Pereira DR, Ribeiro F, Silva-Fernandes A, Federspiel C, Steinmetz JP, Leist AK. The MEDITAGING study: protocol of a two-armed randomized controlled study to compare the effects of the mindfulness-based stress reduction program against a health promotion program in older migrants in Luxembourg. BMC Public Health. 2023 Dec 11;23(1):2470. doi: 10.1186/s12889-023-17387-9.

Reference Type: DERIVED

PMID: 38082350 (View on PubMed)

Other Identifiers

ULuxembourg

Identifier Type: -

Identifier Source: org_study_id