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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”

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.

SUBMITTER: Mapurunga M

PROVIDER: S-EPMC7793825 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. OBJECTIVE:This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. METHODS:Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. RESULTS:In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice. CONCLUSIONS:The program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance. CLINICALTRIAL:ClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4).

Project description:ObjectivesCultural differences between the USA and France led us to examine the feasibility, acceptability and preliminary efficacy data on craving, quality of life and psychological flexibility of the add-on Mindfulness-Based Relapse Prevention (MBRP) programme in alcohol use disorder (AUD) in France.DesignWe conducted a prospective observational study with a 6-month follow-up.SettingThe study was performed in a naturalistic setting with adult outpatients from an addiction department.ParticipantsWe included all patients with a current AUD who participated in the MBRP programme (n=52). There was no non-inclusion criterion.InterventionsThe intervention was an 8-week MBRP programme, combining elements of traditional relapse prevention cognitive behavioural therapy and mindfulness meditation training. This was an eight-session closed-group programme.Primary and secondary outcome measuresPrimary outcomes were the number of attended treatment sessions, home practice frequency and dropout rate. Secondary outcomes were changes in craving, quality of life, psychological flexibility, drinking outcomes, depression, anxiety and mindfulness levels.ResultsThe average number of completed sessions was 6.6 (SD: 1.9). Most participants introduced mindfulness meditation into their everyday lives: 69% and 49% of included patients maintained formal practice at 3 and 6 months, respectively, and 80% and 64% maintained informal practice at 3 and 6 months, respectively. Most participants used mindfulness techniques to face high-risk situations (56% at 6 months). Participants reported a significant reduction in craving, days of alcohol use, depression and anxiety and an increase in mindfulness and psychological flexibility at 6 months.ConclusionsThe MBRP programme showed good acceptability and feasibility. MBRP seemed to improve craving, mindfulness and psychological flexibility. Comparative studies are needed to evaluate the programme's efficacy in AUD.Trial registration number2200863 v 0.

Project description:BackgroundAbout 1 in 3 adults aged 65 and older falls annually. Exercise interventions are effective in reducing the fall risk and fall rate among older adults. In 2020, startup company Age Bold Inc. disseminated the Bold Fall Prevention Program, aiming to reduce falls among older adults through a remotely delivered, digital exercise program.ObjectiveWe conducted a feasibility study to assess the delivery of the Bold Fall Prevention Program remotely and evaluate the program's impact on 2 primary outcomes-annualized fall rate and weekly minutes of physical activity (PA)-over 6 months of follow-up.MethodsOlder adults at high risk of falling were screened and recruited for the feasibility study via nationwide digital advertising strategies. Self-reported outcomes were collected via surveys administered at the time of enrollment and after 3 and 6 months. Responses were used to calculate changes in the annualized fall rate and minutes of PA per week.ResultsThe remote delivery of a progressive digital fall prevention program and associated research study, including remote recruitment, enrollment, and data collection, was deemed feasible. Participants successfully engaged at home with on-demand video exercise classes, self-assessments, and online surveys. We enrolled 65 participants, of whom 48 (74%) were women, and the average participant age was 72.6 years. Of the 65 participants, 54 (83%) took at least 1 exercise class, 40 (62%) responded to at least 1 follow-up survey at either 3 or 6 months, 20 (31%) responded to both follow-up surveys, and 25 (39%) were lost to follow-up. Among all participants who completed at least 1 follow-up survey, weekly minutes of PA increased by 182% (ratio change=2.82, 95% CI 1.26-6.37, n=35) from baseline and annualized falls per year decreased by 46% (incidence rate ratio [IRR]=0.54, 95% CI 0.32-0.90, n=40). Among only 6-month survey responders (n=31, 48%), weekly minutes of PA increased by 206% (ratio change=3.06, 95% CI 1.43-6.55) from baseline to 6 months (n=30, 46%) and the annualized fall rate decreased by 28% (IRR=0.72, 95% CI 0.42-1.23) from baseline to 6 months.ConclusionsThe Bold Fall Prevention Program provides a feasible strategy to increase PA and reduce the burden of falls among older adults.

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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”

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