The ATENción Plena en Enfermedad de Alzheimer (ATENEA-Mindfulness in Alzheimer's Disease) Program for Caregivers : Study Protocol for a Randomized Controlled Trial

A person affected by Alzheimer's disease (AD) gradually loses the ability to perform activities of daily living and becomes dependent on caregivers, thereby having a negative impact on the caregivers' quality of life. There is evidence that suggests that interventions aimed at caregivers, such as mindfulness, may be effective at reducing this burden and emotional issues, such as depression and anxiety, and improving their quality of life. However, there is a lack of consistency in the findings and conclusions remain tentative. In addition, as neuropsychiatric symptoms (NPSs) of AD are major determinants of the caregiver's burden, these interventions should examine the relationship between these symptoms and caregiver outcomes. Importantly, to improve the design of therapeutic interventions for caregivers and complement the treatment of AD, aspects related to occupational performance and the participation of people with AD and their caregivers should also be considered. Therefore, this study will aim to examine first, the effects of a mindfulness-based program designed for caregivers on NPSs of AD and caregivers' anxiety and depression; second, the effects of this program on patients' functional capacity, cognitive performance, executive functions, and quality of life, and on caregivers' burden, quality of life, occupational balance, executive functions, psychological wellbeing, and self-compassion. We believe that the findings of this study will have significant implications for future healthcare strategies focused on improving the quality of life and wellbeing of caregivers

Effects of a mindfulness-based program on the occupational balance and mental health of university students. Protocol for a randomized controlled trial.

OBJECTIVE: The aim is to examine whether the addition of Virtual Reality (VR) meditation training to a standard 8-week Mindfulness-Based Health Care Program (MBHC-VR) results in a significantly increased improvement in occupational, mental health, and psychological functioning versus MBHC-only in university students. MATERIALS AND METHODS: A randomized controlled clinical trial with three arms (MBHC, MBHC-VR, Control Group), four assessment time points (pre-intervention, inter-session, post-intervention, and 3-month follow-up), and mixed methodology will be proposed. University students (undergraduate, master, or doctoral) interested in participating and who meet the inclusion/exclusion criteria will be included over two years. Data will be collected from different ad hoc questionnaires, several standardized tests, and an Ecological Momentary Assessment. We will use R software to carry out descriptive analyses (univariate and bivariate), multilevel modeling, and structural equation models to respond to the proposed objective. The qualitative analysis will be carried out using the MAXQDA program and the technique of focus groups. DISCUSSION: It is expected that with the proposed intervention university students will learn to relate in a healthier way with their mental processes, so as to improve their occupational balance (OB) and their psychological well-being. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05929430

Summary of the quantitative data collection for the research.

Summary of the quantitative data collection for the research.</p

Questions included on Ecological Momentary Assessment (EMA).

Questions included on Ecological Momentary Assessment (EMA).</p

Research project submitted to the ethics committee (Original).

Research project submitted to the ethics committee (Original).</p

Research project submitted to the ethics committee (English).

Research project submitted to the ethics committee (English).</p

SPIRIT checklist.

ObjectiveThe aim is to examine whether the addition of Virtual Reality (VR) meditation training to a standard 8-week Mindfulness-Based Health Care Program (MBHC-VR) results in a significantly increased improvement in occupational, mental health, and psychological functioning versus MBHC-only in university students.Materials and methodsA randomized controlled clinical trial with three arms (MBHC, MBHC-VR, Control Group), four assessment time points (pre-intervention, inter-session, post-intervention, and 3-month follow-up), and mixed methodology will be proposed. University students (undergraduate, master, or doctoral) interested in participating and who meet the inclusion/exclusion criteria will be included over two years. Data will be collected from different ad hoc questionnaires, several standardized tests, and an Ecological Momentary Assessment. We will use R software to carry out descriptive analyses (univariate and bivariate), multilevel modeling, and structural equation models to respond to the proposed objective. The qualitative analysis will be carried out using the MAXQDA program and the technique of focus groups.DiscussionIt is expected that with the proposed intervention university students will learn to relate in a healthier way with their mental processes, so as to improve their occupational balance (OB) and their psychological well-being.Trial registrationClinicalTrials.gov Identifier NCT05929430.</div

Structure of sessions in the mindfulness-based health care program.

Structure of sessions in the mindfulness-based health care program.</p

Flowchart of the study procedure.

Abbreviations: MBHC: Mindfulness-Based Health Care; MBHC-VR: Mindfulness-Based Health Care with virtual reality; WL: waiting list.</p

Thematic guide for focus group discussions.

ObjectiveThe aim is to examine whether the addition of Virtual Reality (VR) meditation training to a standard 8-week Mindfulness-Based Health Care Program (MBHC-VR) results in a significantly increased improvement in occupational, mental health, and psychological functioning versus MBHC-only in university students.Materials and methodsA randomized controlled clinical trial with three arms (MBHC, MBHC-VR, Control Group), four assessment time points (pre-intervention, inter-session, post-intervention, and 3-month follow-up), and mixed methodology will be proposed. University students (undergraduate, master, or doctoral) interested in participating and who meet the inclusion/exclusion criteria will be included over two years. Data will be collected from different ad hoc questionnaires, several standardized tests, and an Ecological Momentary Assessment. We will use R software to carry out descriptive analyses (univariate and bivariate), multilevel modeling, and structural equation models to respond to the proposed objective. The qualitative analysis will be carried out using the MAXQDA program and the technique of focus groups.DiscussionIt is expected that with the proposed intervention university students will learn to relate in a healthier way with their mental processes, so as to improve their occupational balance (OB) and their psychological well-being.Trial registrationClinicalTrials.gov Identifier NCT05929430.</div