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

NCT05615337 | Completed DMC

• 1 other identifier: ULuxembourg
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Changes in cortisol levels comparing the two groups over time

  T1- baseline before the intervention; T2 - 8 weeks after baseline

• Qualitative interview comparing the two groups over time

  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

  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

  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

  T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention

Study Arms (2)

Mindfulness-based stress reduction - MBSR

EXPERIMENTAL

Traditional MBSR curriculum

Behavioral: MBSR

Health Promotion Program - HPP

ACTIVE COMPARATOR

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

Behavioral: HPP

Interventions

MBSR 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.

Mindfulness-based stress reduction - MBSR

HPP 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.

Health Promotion Program - HPP

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Luxembourg: lead
• Luxembourg National Research Fund (FNR): collaborator

Study Sites (1)

University of Luxembourg

Luxembourg, Other, 4700-154, Luxembourg

Location

Related Publications (1)

• 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.

  PMID: 38082350 DERIVED

Study Officials

• Anja Leist, PhD

  University of Luxembourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: November 14, 2022
• Study Start: April 26, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 22, 2024

Record last verified: 2023-05

Locations

LU (1)