Effect of the Mindfulness-Based Health Promotion Program (MBHP) in the Elderly: a RCT
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|ClinicalTrials.gov Identifier: NCT03706807|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life Cognitive Impairment Psychological||Other: Mindfulness-Based Intervention Other: Cognitive Stimulation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||September 18, 2018|
|Estimated Primary Completion Date :||March 20, 2020|
|Estimated Study Completion Date :||March 20, 2022|
Experimental: 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".
Other: Mindfulness-Based Intervention
This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
Active Comparator: 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.
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
No Intervention: Naïve
It's a waiting list group which will receive no intervention.
- 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
- Montreal Cognitive Assessment (MoCA) [ Time Frame: 51 months ]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.
- Self-Compassion Scale [ Time Frame: 51 months ]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.
- Freiburg Mindfulness Inventory [ Time Frame: 51 months ]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.
- Depression Anxiety and Stress Scale - Short Form (DASS-21) [ Time Frame: 51 months ]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.
- Pittsburg Sleep Quality Index (PSQI) [ Time Frame: 51 Months ]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.
- The Duke University Religion Index [ Time Frame: 51 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706807
|Contact: Marcelo MP Demarzo, PhDfirstname.lastname@example.org|
|Contact: Marcelo V Mapurungaemail@example.com|
|Principal Investigator:||Marcelo MP Demarzo, PhD||Federal University of São Paulo|