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

Sponsor
University of Luxembourg (Other)
Overall Status
Recruiting
CT.gov ID
NCT05615337
Collaborator
Luxembourg National Research Fund (FNR) (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MBSR
  • Behavioral: HPP
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Mindfulness Training in Aging: the Effects of a Stress Reduction Program on Portuguese-speaking People Aged Fifty-five and Over Residing in Luxembourg
Actual Study Start Date :
Apr 26, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Trail Making Test

  2. 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 Stroop Test

  3. 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

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Luxembourg Luxembourg Other Luxembourg 4700-154

Sponsors and Collaborators

  • University of Luxembourg
  • Luxembourg National Research Fund (FNR)

Investigators

  • Principal Investigator: Anja Leist, PhD, University of Luxembourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Luxembourg
ClinicalTrials.gov Identifier:
NCT05615337
Other Study ID Numbers:
  • ULuxembourg
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 14, 2022