Protocol for a Nested Randomized Controlled Trial to Evaluate the Feasibility and Preliminary Efficacy of the Mindfulness Based Health Promotion Program on the Quality of Life of Older Adults Assisted in Primary Care-"The MBHP-Elderly Study".
Marcelo Vasconcelos Mapurunga, Solange Andreoni, Daniela Rodrigues de Oliveira, Vicente Sarubbi, Ana Claudia Bonilha, Vania D'Almeida, Luciana Tomita, Luiz Roberto Ramos, Marcelo Demarzo
Frontiers in Medicine November 30, 2020 DOI: 10.3389/fmed.2020.563099 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol (cohort-nested, mixed-methods, 3 assessment points) Qualitative Peer reviewed |
|---|---|
| Sample size | 102 |
| Population | Older adults recruited from a cohort at a primary care facility in a Latin American population |
| Duration | 3 assessment points: baseline, post-intervention, and 1-year follow-up |
| Measures | WHOQOL-BREF, WHOQOL-OLD, adherence and unwanted effects questionnaires, focus group, word free evocation technique |
| Topics | Meditation |
| Keywords | Elderly Quality of life Health promotion source Mbhp Mindfulness mesh Nhl Primary care mesh |
| Registration | NCT03048708 |
| Key findings | The protocol proposes that a Mindfulness-Based Health Promotion program may be feasible and may improve quality of life in older adults in primary care, compared with a cognitive stimulation control group. The authors note that evidence on mindfulness-based interventions for older people is still scarce and describe this as the first mixed-methods trial of its kind in a Latin American older population. |
Abstract
Introduction: Population aging is a global phenomenon that has grown rapidly and progressively all over the world. Interventions that promote health must be studied and implemented to make the aging process be with quality of life. Depression and anxiety are the most common mental health conditions that compromise the quality of life on the elderly and it can cause damage to the autonomy and activities of daily life. Mindfulness training has been shown to improve psychological health and quality of life on adults. Studies involving Mindfulness-Based Interventions (MBIs) with older people are scarce in the literature, but they have been increasing in recent years showing promising results for healthy aging. This trial will investigate the feasibility and preliminary efficacy of an MBI on the quality of life of elderly assisted in the Primary Care.
Materials and Methods: A cohort-nested randomized controlled trial with 3 assessment points (baseline, post-intervention and 1-year follow up) will be conducted to compare a MBI program (Mindfulness-Based Health Promotion) to a cognitive stimulation control-group in a Primary Care facility. One-hundred and two older adults will be recruited from a cohort of this facility and they will be randomized and allocated into an intervention group (N = 76) and the control group (N = 76). The primary outcome evaluated will be the improvement of quality of life assessed by the WHOQOL-BREF and WHOQOL-OLD. The secondary outcomes will be cognitive function, psychological health, sleep quality, self-compassion, and religiosity. Qualitative data will be assessed by focus group and the word free evocation technique. The feasibility of the program will also be evaluated by adherence and unwanted effects questionnaires.
Discussion: This cohort-nested clinical trial will be the first mixed-methods study with 3 assessment points which will study the feasibility and preliminary efficacy of a mindfulness-based program for older people in Latin America population. If the findings of this study confirm the effectiveness of this program in this population it will be possible to consider it as intervention that might be implemented as public policy addressed to older people in healthcare systems. Clinical
Trial Registration: www.ClinicalTrials.gov, identifier: NCT03048708. Registered retrospectively on October 11th 2018.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 3
- Mindfulness Training for Primary Care for Portuguese-Speaking Immigrants: A Pilot Study Frontiers in Psychiatry September 9, 2021
- Effects of mindfulness training on quality of life and well-being in older adults: a randomized controlled trial. Aging & Mental Health April 12, 2025
- Mindfulness enhancements predict aberrant salience reductions and improve stress management. Discover Mental Health April 8, 2025
Cites 25
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- Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse JAMA Psychiatry April 28, 2016
- Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Psychosomatic Medicine July 1, 2003
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