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Completed

NCT Number: NCT05615337

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

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Luxembourg

Luxembourg, Other, 4700-154

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in executive functioning comparing the two groups over time

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

    Assessed by the Trail Making Test

  2. Changes in executive functioning comparing the two groups over time

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

    Assessed by the Stroop Test

  3. Changes in executive functioning comparing the two groups over time

    Time frame: 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 outcomes

  1. Changes in cortisol levels comparing the two groups over time

    Time frame: T1- baseline before the intervention; T2 - 8 weeks after baseline

    assessed by collecting saliva at baseline and post-intervention

  2. Qualitative interview comparing the two groups over time

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

    Interview asking about the program challenges and benefits

  3. Changes in the dispositional mindfulness comparing the two groups over time

    Time frame: 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)

  4. Change in stress levels comparing the two groups over time

    Time frame: 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

  5. Change in the heart rate assessment comparing the two groups over time

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

    Heart rate variability

  6. Change in sleep quality comparing the two groups over time

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

    Pittsburgh sleep quality index

  7. Changes in general cognition comparing the two groups over time

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

    Mini-Mental State Questionnaire

  8. Changes in humor between the two groups over time

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

    Geriatric Anxiety Inventory (GAI)

Sponsors and collaborators

Lead sponsor

University of Luxembourg

Other

Collaborators

  • Luxembourg National Research Fund

Registry information

Official study title

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

Acronym: MEDITAGING

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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