MindfulnessMEDITAGINGNCT05615337
Mindfulness Training: the Effects of a Stress Reduction Program on Older Portuguese-speaking People in Luxembourg
A study testing MBSR and HPP in people with Mindfulness and Healthy Aging, run by University of Luxembourg at 1 site in Luxembourg.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Healthy Aging
- What is being tested?
- MBSR and HPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteLuxembourg
- Study dates
- 26 Apr 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- MBSR, HPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
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.
HPPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction - MBSR | Experimental | Traditional MBSR curriculum Receives: Behavioral: MBSR |
| Health Promotion Program - HPP | Active comparator | the HPP has the same structure of MBSR, but training different components, not including mindfulness practice. Receives: Behavioral: HPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in executive functioning comparing the two groups over time
Assessed by the Trail Making Test
Measured: 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
Measured: 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
Measured: 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
assessed by collecting saliva at baseline and post-intervention
Measured: T1- baseline before the intervention; T2 - 8 weeks after baseline
Qualitative interview comparing the two groups over time
Interview asking about the program challenges and benefits
Measured: 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
The Mindfulness Attention and Awareness Scale (MAAS)
Measured: 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
Assessed by the Perceived Stress Scale
Measured: 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
Heart rate variability
Measured: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
Change in sleep quality comparing the two groups over time
Pittsburgh sleep quality index
Measured: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
Changes in general cognition comparing the two groups over time
Mini-Mental State Questionnaire
Measured: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
Changes in humor between the two groups over time
Geriatric Anxiety Inventory (GAI)
Measured: T1- baseline before the intervention; T2 - 8 weeks after baseline; T3 - 1 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start26 Apr 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luxembourg
- Sponsor type
- University, hospital or other
- Collaborators
- Luxembourg National Research Fund
- Responsible party
- Sponsor
- Investigators
- Anja Leist, PhD, Principal investigator, University of Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615337
- Sponsor's protocol ID
- ULuxembourg
- Acronym
- MEDITAGING
- Status last verified
- May 2023
- First submitted
- 27 Sep 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38082350
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05615337
- Acronym / sponsor ID
- MEDITAGING / ULuxembourg
- Conditions
- Mindfulness, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of LuxembourgUniversity, hospital or other
- Collaborators
- Luxembourg National Research Fund
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction - MBSR | Experimental | Behavioral: MBSRTraditional MBSR curriculum |
| Health Promotion Program - HPP | Active comparator | Behavioral: HPPthe HPP has the same structure of MBSR, but training different components, not including mindfulness practice. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRThe 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. | Behavioural | Mindfulness-based stress reduction - MBSR |
| HPPThe 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. | Behavioural | Health Promotion Program - HPP |
Primary outcome
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
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
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
8 secondary outcomes
Changes in cortisol levels comparing the two groups over time
Time frame: T1- baseline before the intervention; T2 - 8 weeks after baseline
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
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.
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.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Derived from this study: PubMed 38082350Teixeira-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Leist, PhD principal investigator
University of Luxembourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR and HPP in people with Mindfulness and Healthy Aging, run by University of Luxembourg at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.