Effect of the Mindfulness-Based Health Promotion Program (MBHP) in the Elderly: a RCT
1 other identifier
interventional
172
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Sep 2018
Longer than P75 for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2018
CompletedFirst Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2022
CompletedFebruary 15, 2019
February 1, 2019
1.5 years
October 3, 2018
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
51 months
Secondary Outcomes (6)
Montreal Cognitive Assessment (MoCA)
51 months
Self-Compassion Scale
51 months
Freiburg Mindfulness Inventory
51 months
Depression Anxiety and Stress Scale - Short Form (DASS-21)
51 months
Pittsburg Sleep Quality Index (PSQI)
51 Months
- +1 more secondary outcomes
Study Arms (3)
Mindfulness-Based Intervention
EXPERIMENTALThis 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 COMPARATORThe 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 INTERVENTIONIt's a waiting list group which will receive no intervention.
Interventions
This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
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
Eligibility Criteria
You may qualify if:
- men and women aged 60 or over;
- be classified as cognitively normal or with mild cognitive impairment;
- know how to read and write.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Mente Aberta de Mindfulness e Promoção de Saúde
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo MP Demarzo, PhD
Federal University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 16, 2018
Study Start
September 18, 2018
Primary Completion
March 20, 2020
Study Completion
March 20, 2022
Last Updated
February 15, 2019
Record last verified: 2019-02