Quality of LifeNCT03706807
Effect of the Mindfulness-Based Health Promotion Program (MBHP) in the Elderly: a RCT
A study testing Mindfulness-Based Intervention and Cognitive Stimulation in people with Quality of Life and Cognitive Impairment, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.
Trial summary
According to the World Health Organization (WHO), it is estimated that by 2025 the number of older people in Brazil will be approximately 33.4 million and it will be the sixth population in absolute numbers of the elderly in the world. Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Cognitive Impairment, Psychological
- What is being tested?
- Mindfulness-Based Intervention and Cognitive Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Sep 2018to 20 Mar 2022
- 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 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women aged 60 or over;
- be classified as cognitively normal or with mild cognitive impairment;
- know how to read and write.
Who cannot join
- practice contemplative practices such as yoga, reiki, tai-chi-chuan, vipassana, zen-buddhism, mindfulness and any other type of meditative practice in the last 6 months (with formal practice at least once / week);
- individuals with acute phase of depression;
- those with severe hearing or vision impairment;
- clinical diagnosis of schizophrenia or any other psychotic disorders;
- currently taking drugs that affect cognitive functions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro Mente Aberta de Mindfulness e Promoção de Saúde
São Paulo, São Paulo
Marcelo V Mapurunga, +5585991464787, marcelovmapurunga@gmail.com
Daniela R Oliveira, PhD, +5511999287619, danielaoliveira.phd@gmail.com
About this study
Official title: Effect of the Mindfulness-Based Health Promotion Program - MBHP on Quality of Life and Maintenance of Cognitive Function in the Elderly: a Randomized Controlled Trial
According to the World Health Organization (WHO), it is estimated that by 2025 the number of older people in Brazil will be approximately 33.4 million and it will be the sixth population in absolute numbers of the elderly in the world. The aging process is often associated with natural health debilitation, impairment of cognitive abilities, depression, loneliness and decreased daily life activity. Therefore, by increasing the number of older people also increase the needs and demands of health systems to serve this population. Government programs and projects that promote health and quality of life for this group must be developed and researched, so that the population aging happens in a satisfactory way and with physical and mental health. Several researches have been done on interventions that prevent the symptoms of memory impairment in elderly and on delaying symptoms of Mild Cognitive Impairment. Studies indicate that Mindfulness-Based Interventions (IBMs) are effective in the treatment of depression, anxiety, stress, chronic pain and in promoting well-being to young people and adults, yet the field of study of these interventions with the elderly is still a field to be explored and deepened. This project will focus on the discussion about the effectiveness of the Mindfulness-Based Health Promotion Program (MBHP) in the cognitive functions and quality of life of the elderly, based on quantitative and qualitative analysis. It will be used neuropsychological test and scales to assess the level of consciousness in the present moment, acceptance, self-compassion, quality of life and daily life activity, as well as a qualitative analysis through a structured script using the word evocation method and interviews through focus group.
Read the detailed description
The MBHP-elderly study is a randomized and controlled trial of older people with 3 assessment point (baseline, post-intervention and six-months follow up) made with a cohort study whose participants will be older adults patients assisted in Primary Health Care of the Center for Aging Studies of the Federal University of São Paulo.
152 Participants will be recruited from the cohort and then randomized into the following groups: (I) MBHP intervention group (76 participants) in which the elderly will have a weekly meeting of an hour and thirty minutes for eight weeks to perform the mindfulness-based interventions accompanied by plus four one-hour meetings through a maintenance group after conclusion of the program, totaling 16 hours; (II) TAU control group (76 participants) of elderly who will take a cognitive simulation through computers for four months, a week meeting, totaling 16 hours. In both groups will be applied the same assessment for data collection and they will be applied in the baseline, post-intervention and six-month follow up. The steps of the study will be conducted based on Consolidated Standards of Reporting Trials (CONSORT) guidelines to report clinical studies in a clear, transparent and comprehensive manner. The protocol is reported according to the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) statement.
- Conditions
- Quality of Life, Cognitive Impairment, Psychological
- Being tested
- Mindfulness-Based Intervention, Cognitive Stimulation
- Keywords
- Mindfulness, Older people, Quality of Life, Cognitive Function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based InterventionOther
This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
Cognitive StimulationOther
A basic computer workshop in order to develop the psychomotricity involving the use of mouse, keyboard, MS paint, photo gallery and PowerPoint presentations to surf on the internet, learn how to play online games and use social networks
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Intervention | Experimental | This group will be included in the eight-week mindfulness program following the Mindfulness-Based Health Promotion (MBHP) protocol. The group will have a weekly meeting of an hour and thirty minutes for eight weeks to perform the mindfulness-based interventions accompanied by plus four one-hour meetings through a maintenance group after conclusion of the program, totaling 16 hours. The training will be lead by a certified instructor and he will introduce practices such as "mindfulness in breathing", "body scan", "mindful walking", "mindful movements" and "3-minutes of mindfulness" and the concepts of "first and second suffering" and the "Hi-Thanks-Bye". Receives: Other: Mindfulness-Based Intervention |
| Cognitive Stimulation | Active comparator | The basic workshop is considered a cognitive stimulation and the participants will receive an hour and thirty minutes class once a week during four months. The abilities learned at the workshop will be basic computer functions from development of the psychomotricity involving the use of mouse, keyboard, MS paint, photo gallery and PowerPoint presentations to surf on the internet, learn how to play online games and use social networks. The activities of the workshop are elaborated according to the development of each class and is participants. Receives: Other: Cognitive Stimulation |
| Naïve | No intervention | It's a waiting list group which will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
It was developed by the World Health Organization, the instrument is a short version of WHOQOL-100 and it comprises 26 items in which two are general about quality of life and the other 24 grouped into four domains related to quality of life and general health: physical health, psychological health, social relationships and environment. It presents Likert scale answer (1 to 5 points) and it is evaluated the mean of each subscale
Measured: 51 months
Secondary outcomes (6)
Montreal Cognitive Assessment (MoCA)
It assess the cognitive function. It is a 12-items test that measure eight cognitive domains: short-term memory (delayed drawing); visuospatial abilities (cube drawing, clock drawing); executive function (trail-making test; phonemic verbal fluency; verbal abstraction); attention, concentration, working memory; language; orientation to time. The test total score is 30 points where a score greater than or equal to 26 indicates normality and less than 25 points indicates Mild Cognitive Impairment.
Measured: 51 months
Self-Compassion Scale
To measure the level of self-compassion of the individual. The Self-Compassion Scale consists of 26 items divided into 6 subscales for self-kindness; self-judgment; mindfulness; common humanity; and isolation. The answers are given in 5 points of the Likert scale which (1) is almost never and (5) is almost always.
Measured: 51 months
Freiburg Mindfulness Inventory
it comprises 14 items that aim to identify through self-assessment the individual's perception of the frequency that the one experiences behaviors related to mindfulness (awareness to the present moment). The answers are marked on a Likert scale of 4 frequency levels: (1) Rarely; (2) Occasionally; (3) Fairly often; (4) Almost always. The total score ranges from 14 to 56 points and the higher the score the greater the mindfulness perception of the individual.
Measured: 51 months
Depression Anxiety and Stress Scale - Short Form (DASS-21)
In order to assess psychological health we will use the DASS-21. It is a 21-item scale that measure and divide the symptoms of anxiety, depression and stress, in which participants indicate the degree to which they experienced these symptoms in the previous week on 7 items in each subscale: depression, anxiety and stress. It is a Likert-scale of 4 points between 0 to 3. The highest score in each subscale refer to more negative affective states.
Measured: 51 months
Pittsburg Sleep Quality Index (PSQI)
it is an instrument that evaluates the sleep quality of individual's the last month. It comprises 19 questions in self-report and 5 questions answered by some third party in which it will be made by phone call to a caregiver, relative or spouse. The components of the PSQI are C1 subjective sleep quality; C2 sleep latency; C3 sleep duration; C4 habitual sleep efficiency, C5 sleep disturbance, C6 Use of sleeping medication; C7 daytime dysfunction. Categorized as seven components in scores from zero (no difficulty) to three (severe difficulty). The sum of the results can range from zero to twenty-one scores, where the higher the number the worse quality of sleep.
Measured: 51 Months
The Duke University Religion Index
It is a 5-item scale that measure three major dimensions of religiousness: (1) organizational, the frequency of attending public religious activities and group-related; (2) nonorganizational, which involves religious activities performed in private, such as prayer, scripture study, watching religious TV or listening to religious radio; (3) Intrinsic religiosity, assessing the degree of personal religious commitment or motivations.
Measured: 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start18 Sep 2018
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Mente Aberta de Mindfulness
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Demarzo, MD, PhD, Centro Mente Aberta de Mindfulness
- Investigators
- Marcelo MP Demarzo, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706807
- Sponsor's protocol ID
- 89700318.0.0000.5505
- Status last verified
- Feb 2019
- First submitted
- 3 Oct 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Mindfulness-Based Health Promotion Program - MBHP on Quality of Life and Maintenance of Cognitive Function in the Elderly: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03706807
- Acronym / sponsor ID
- 89700318.0.0000.5505
- Conditions
- Quality of Life, Cognitive Impairment, Psychological
- Keywords
- Mindfulness, Older people, Quality of Life, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Centro Mente Aberta de MindfulnessUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 16 Oct 2018 (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.
According to the World Health Organization (WHO), it is estimated that by 2025 the number of older people in Brazil will be approximately 33.4 million and it will be the sixth population in absolute numbers of the elderly in the world. The aging process is often associated with natural health debilitation, impairment of cognitive abilities, depression, loneliness and decreased daily life activity. Therefore, by increasing the number of older people also increase the needs and demands of health systems to serve this population. Government programs and projects that promote health and quality of life for this group must be developed and researched, so that the population aging happens in a satisfactory way and with physical and mental health. Several researches have been done on interventions that prevent the symptoms of memory impairment in elderly and on delaying symptoms of Mild Cognitive Impairment. Studies indicate that Mindfulness-Based Interventions (IBMs) are effective in the treatment of depression, anxiety, stress, chronic pain and in promoting well-being to young people and adults, yet the field of study of these interventions with the elderly is still a field to be explored and deepened. This project will focus on the discussion about the effectiveness of the Mindfulness-Based Health Promotion Program (MBHP) in the cognitive functions and quality of life of the elderly, based on quantitative and qualitative analysis. It will be used neuropsychological test and scales to assess the level of consciousness in the present moment, acceptance, self-compassion, quality of life and daily life activity, as well as a qualitative analysis through a structured script using the word evocation method and interviews through focus group.
Detailed description
The MBHP-elderly study is a randomized and controlled trial of older people with 3 assessment point (baseline, post-intervention and six-months follow up) made with a cohort study whose participants will be older adults patients assisted in Primary Health Care of the Center for Aging Studies of the Federal University of São Paulo.
152 Participants will be recruited from the cohort and then randomized into the following groups: (I) MBHP intervention group (76 participants) in which the elderly will have a weekly meeting of an hour and thirty minutes for eight weeks to perform the mindfulness-based interventions accompanied by plus four one-hour meetings through a maintenance group after conclusion of the program, totaling 16 hours; (II) TAU control group (76 participants) of elderly who will take a cognitive simulation through computers for four months, a week meeting, totaling 16 hours. In both groups will be applied the same assessment for data collection and they will be applied in the baseline, post-intervention and six-month follow up. The steps of the study will be conducted based on Consolidated Standards of Reporting Trials (CONSORT) guidelines to report clinical studies in a clear, transparent and comprehensive manner. The protocol is reported according to the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) statement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention | Experimental | Other: Mindfulness-Based InterventionThis group will be included in the eight-week mindfulness program following the Mindfulness-Based Health Promotion (MBHP) protocol. The group will have a weekly meeting of an hour and thirty minutes for eight weeks to perform the mindfulness-based interventions accompanied by plus four one-hour meetings through a maintenance group after conclusion of the program, totaling 16 hours. The training will be lead by a certified instructor and he will introduce practices such as "mindfulness in breathing", "body scan", "mindful walking", "mindful movements" and "3-minutes of mindfulness" and the concepts of "first and second suffering" and the "Hi-Thanks-Bye". |
| Cognitive Stimulation | Active comparator | Other: Cognitive StimulationThe basic workshop is considered a cognitive stimulation and the participants will receive an hour and thirty minutes class once a week during four months. The abilities learned at the workshop will be basic computer functions from development of the psychomotricity involving the use of mouse, keyboard, MS paint, photo gallery and PowerPoint presentations to surf on the internet, learn how to play online games and use social networks. The activities of the workshop are elaborated according to the development of each class and is participants. |
| Naïve | No intervention | –It's a waiting list group which will receive no intervention. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women aged 60 or over;
- be classified as cognitively normal or with mild cognitive impairment;
- know how to read and write.
Key exclusion criteria (5 listed)
- practice contemplative practices such as yoga, reiki, tai-chi-chuan, vipassana, zen-buddhism, mindfulness and any other type of meditative practice in the last 6 months (with formal practice at least once / week);
- individuals with acute phase of depression;
- those with severe hearing or vision impairment;
- clinical diagnosis of schizophrenia or any other psychotic disorders;
- currently taking drugs that affect cognitive functions.
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 |
|---|---|---|
| Mindfulness-Based InterventionThis intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol | Other | Mindfulness-Based Intervention |
| Cognitive StimulationA basic computer workshop in order to develop the psychomotricity involving the use of mouse, keyboard, MS paint, photo gallery and PowerPoint presentations to surf on the internet, learn how to play online games and use social networks | Other | Cognitive Stimulation |
Primary outcome
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: 51 months
It was developed by the World Health Organization, the instrument is a short version of WHOQOL-100 and it comprises 26 items in which two are general about quality of life and the other 24 grouped into four domains related to quality of life and general health: physical health, psychological health, social relationships and environment. It presents Likert scale answer (1 to 5 points) and it is evaluated the mean of each subscale
6 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: 51 months
Self-Compassion Scale
Time frame: 51 months
Freiburg Mindfulness Inventory
Time frame: 51 months
Depression Anxiety and Stress Scale - Short Form (DASS-21)
Time frame: 51 months
Pittsburg Sleep Quality Index (PSQI)
Time frame: 51 Months
The Duke University Religion Index
Time frame: 51 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Marcelo MP Demarzo, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention and Cognitive Stimulation in people with Quality of Life and Cognitive Impairment, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo MP Demarzo, PhD (+5511533854350, marcelodemarzo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life-BREF (WHOQOL-BREF) (time frame: 51 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.