Effect of the Mindfulness-Based Health Promotion Program (MBHP) in the Elderly: a RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-18

Study Completion Date

2022-03-20

Brief Summary

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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.

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Detailed Description

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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

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Quality of Life Cognitive Impairment Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindfulness-Based Intervention

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".

Group Type EXPERIMENTAL

Mindfulness-Based Intervention

Intervention Type OTHER

This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol

Cognitive Stimulation

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.

Group Type ACTIVE_COMPARATOR

Cognitive Stimulation

Intervention Type OTHER

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

Naïve

It's a waiting list group which will receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-Based Intervention

This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol

Intervention Type OTHER

Cognitive Stimulation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* men and women aged 60 or over;
* be classified as cognitively normal or with mild cognitive impairment;
* know how to read and write.

Exclusion Criteria

* 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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes