Clinical trial NCT03706807: Effect of the Mindfulness-Based Health Promotion Program (MBHP) in the Elderly: a RCT
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Cognitive Impairment
Psychological
Keywords: Mindfulness
Older people
Quality of Life
Cognitive Function
Lead sponsor: Centro Mente Aberta de Mindfulness
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 172
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 51 months
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 51 months
measure: Self-Compassion Scale
timeFrame: 51 months
measure: Freiburg Mindfulness Inventory
timeFrame: 51 months
measure: Depression Anxiety and Stress Scale - Short Form (DASS-21)
timeFrame: 51 months
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: 51 Months
measure: The Duke University Religion Index
timeFrame: 51 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centro Mente Aberta de Mindfulness e Promoção de Saúde
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Marcelo MP Demarzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: