Dataset Information

Evaluating the effectiveness of a 6-week hybrid mindfulness-based intervention in reducing the stress among caregivers of patients with dementia during COVID-19 pandemic: protocol of a randomized controlled trial.

ABSTRACT:

Background

Mindfulness-based intervention (MBI), an emotion-focused approach, has been shown promising and sustainable effects on enhancing the well-being of caregivers of patients with dementia (PWD). However, the conventional MBI was quite demanding, had high rates of attrition and inconsistent long-term effect. The social distancing measures introduced during the COVID-19 pandemic also restricted face-to-face psychosocial intervention. The study aims to evaluate the effectiveness of a 6-week hybrid MBI in caregivers of PWD over a 6-month follow up.

Methods

This is a single-blinded, parallel-group randomized controlled trial (RCT). Eligible participants from three local nongovernmental organizations (NGOs) will be randomly divided into intervention groups and control groups in a ratio of 1:1. The participants in the intervention group will receive 6 weekly 90-min group-based sessions delivered through a face-to-face and online approach. The participants in the control group will receive brief education on dementia care with the same group size, duration, and frequency as the sessions in the intervention group. Immediately after the intervention and at the 6-month follow-up, caring stress and other outcomes will be assessed. Besides, a focus group interview will be conducted to identify the strengths, limitations, and therapeutic components of the intervention from their perspectives. For quantitative data, intention-to-treat analysis and Generalized Estimating Equations (GEE) will be used. For qualitative data, content analysis will be used.

Discussion

This proposed hybrid model of MBI has several advantages, such as lower duration, longer follow-up period and easier access by family caregivers. Also, physiological indicators (e.g., heart rate viability and neuropsychiatric symptoms) will be measured in this study to show the body change after MBI. The quantitative and qualitative data of this research can also benefit the development of online or hybrid MBI for caregivers of PWD during the COVID-19 pandemic. Despite these strengths, it does have practical challenges and limitations. However, this proposed intervention has the potential to benefit not only the participants, but also the researcher as well as public health providers.

Trial registration

NCT05242614. Registered on 2022-02-16, https://clinicaltrials.gov/ct2/show/NCT05242614.

SUBMITTER: Kor PPK

PROVIDER: S-EPMC9295093 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating the effectiveness of a 6-week hybrid mindfulness-based intervention in reducing the stress among caregivers of patients with dementia during COVID-19 pandemic: protocol of a randomized controlled trial.

Kor Patrick Pui Kin PPK Li Meng Li ML Kwok Denis Ka Shaw DKS Leung Angela Yee Man AYM Lai Danial Lok Lam DLL Liu Justina Yat Wah JYW

BMC psychology 20220719 1

<h4>Background</h4>Mindfulness-based intervention (MBI), an emotion-focused approach, has been shown promising and sustainable effects on enhancing the well-being of caregivers of patients with dementia (PWD). However, the conventional MBI was quite demanding, had high rates of attrition and inconsistent long-term effect. The social distancing measures introduced during the COVID-19 pandemic also restricted face-to-face psychosocial intervention. The study aims to evaluate the effectiveness of a ...[more]

PMID: 35854347

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Project description:BackgroundCaregiver stress can pose serious health and psychological concerns, highlighting the importance of timely interventions for family caregivers of people with dementia. Single-session mindfulness-based interventions could be a promising yet under-researched approach to enhancing their mental well-being within their unpredictable, time-constrained contexts. This trial will evaluate the effectiveness and feasibility of a blended mindfulness-based intervention consisting of a single session and app-based follow-up in reducing caregiver stress.Methods/designThe study is a single-blinded randomized controlled trial with two arms (intervention versus an education session on dementia care) and assessments at baseline, 8 weeks, and 6 months. The eligibility criteria include: family caregivers aged 18 years or older; providing care for an individual with a confirmed medical diagnosis of dementia for at least 3 months prior to recruitment, with a minimum of 4 hours of daily contact; and exhibiting a high level of caregiver stress. The intervention comprises a 90-minute group-based session with various mindfulness practices and psychoeducation. Participants will receive a self-practice toolkit to guide their practice over a duration of 8 weeks. Sharing activities will be implemented through an online social media platform. The primary outcome is perceived caregiving stress. The secondary outcomes include depressive symptoms, positive aspects of caregiving, dyadic relationship, trait mindfulness, and neuropsychiatric symptoms of care recipients. The feasibility outcomes include eligibility and enrollment, attendance, adherence to self-practice, and retention, assessed using mixed methods.DiscussionThe study will contribute to the evidence base by investigating whether a single-session mindfulness intervention is effective and feasible for reducing caregiver stress among family caregivers of people with dementia.Trial registrationClinicalTrials.gov, NCT06346223. Registered on April 3, 2024.

Project description:IntroductionPatients with long-term conditions consistently report a lack of information around services and support available to them. This unmet need for information is significant among people with dementia and family carers. A quality improvement intervention is being carried out to tackle this issue as part of a co-creation initiative in the North East of England (UK). The intervention consists of the dissemination (via the local Community Mental Health Services for Older People) of a leaflet about services available to people with dementia and their family carers in the study site. This protocol is reported in accordance with the Standards for Reporting Implementation Studies.Methods and analysisThis effectiveness-implementation hybrid type 2 study aims at understanding (1) the unfolding and outcomes of the implementation strategy, (2) the outcomes of the intervention (for people with dementia and family carers, staff implementing the intervention and local service providers) and (3) the contribution of co-creation to the design and implementation of the intervention and its outcomes. The prospective theory of change of the intervention articulated by local stakeholders is used as a reference framework against which to assess the implementation and outcomes of the intervention. Evaluation data will be collected through in-depth interviews with people with dementia and family carers receiving the intervention, staff implementing the intervention and managers from local service providers. Referral data from local service providers will be collected to triangulate the interview data. A focus group with key stakeholders will support the sense-making of findings. The realist configuration of mechanism-context-outcome, operationalised using an information behaviour model, will inform data analysis and interpretation.Ethics and disseminationEthical and research governance approvals have been obtained from the West Midlands-South Birmingham Research Ethics Committee. The results of the study will be submitted for publication in peer-reviewed journals and disseminated through conferences.

Project description:BackgroundCancer among young adults (18-39 years) is relatively rare, but remains a leading cause of disability, morbidity, and mortality. Identifying strategies to support young adults' health following a diagnosis of cancer is important. Yoga may enhance health and could be delivered by videoconference. However, little research exploring yoga, and no research exploring videoconference delivery of yoga has been conducted with this cohort. We worked with young adults affected by cancer and developed, piloted, and refined a yoga intervention delivered by videoconference.ObjectiveTo evaluate our yoga intervention in a full-scale, mixed methods, single-arm, hybrid effectiveness-implementation trial.MethodsYoung adults 18 years or older, diagnosed with cancer between the ages of 18-39 years of age, and at any stage along the cancer trajectory are eligible. Participants receive 2 yoga classes/week over 12-weeks by videoconference and complete assessments at baseline, post-intervention, and 6- and 12-month follow-ups. Assessments include self-reported questionnaires (ie, stress, yoga barriers, physical activity behaviour, fatigue, cognition, cancer-related symptoms, general health, health-related quality of life, self-compassion, mindfulness, group identification), physical assessments (ie, aerobic endurance, flexibility, range of motion, balance, functional mobility), and a semi-structured interview (post-intervention only; exploring perceptions of acceptability, feasibility, and experiences). Quality improvement cycles occur every 6 months. Repeated measures analysis of variance will be conducted to explore effectiveness, descriptive statistics and responder/non-responder analyses will be used to explore implementation, and qualitative interview data, analyzed using content analysis and reflexive thematic analysis, will bolster effectiveness and implementation findings.DiscussionAs the first full-scale trial to evaluate yoga delivered by videoconference for this cohort, findings will make substantial contributions to young adults' supportive cancer care.ConclusionThis protocol, reporting on yoga delivered by videoconference for young adults diagnosed with cancer, will enhance transparency and reproducibility and provide a reference for forthcoming trial results.Trial registrationNCT05314803 at clinicaltrials.gov.

Project description:BackgroundThe World Health Organization stresses the importance of accessible and (cost)effective caregiver support, given the expected increase in the number of people with dementia and the detrimental impact on the mental health of family caregivers.MethodsThis study assessed the effectiveness of the Internet intervention 'Mastery over Dementia'. In a RCT, 251 caregivers, of whom six were lost at baseline, were randomly assigned to two groups. Caregivers in the experimental group (N = 149) were compared to caregivers who received a minimal intervention consisting of e-bulletins (N = 96). Outcomes were symptoms of depression (Center for Epidemiologic Studies Depression Scale: CES-D) and anxiety (Hospital Anxiety and Depression Scale: HADS-A). All data were collected via the Internet, and an intention-to-treat analysis was carried out.ResultsAlmost all caregivers were spouses or children (in-law). They were predominantly female and lived with the care recipient in the same household. Age of the caregivers varied from 26 to 87 years. Level of education varied from primary school to university, with almost half of them holding a bachelor's degree or higher. Regression analyses showed that caregivers in the experimental group showed significantly lower symptoms of depression (p = .034) and anxiety (p = .007) post intervention after adjustment for baseline differences in the primary outcome scores and the functional status of the patients with dementia. Effect sizes were moderate for symptoms of anxiety (.48) and small for depressive symptoms (.26).ConclusionsThe Internet course 'Mastery over Dementia' offers an effective treatment for family caregivers of people with dementia reducing symptoms of depression and anxiety. The results of this study justify further development of Internet interventions for family caregivers of people with dementia and suggest that such interventions are promising for keeping support for family caregivers accessible and affordable. The findings are even more promising because future generations of family caregivers will be more familiar with the Internet.Trial registrationDutch Trial Register NTR-2051 www.trialregister.nl/trialreg/admin/rctview.asp?TC=2051.

Dataset Information

Evaluating the effectiveness of a 6-week hybrid mindfulness-based intervention in reducing the stress among caregivers of patients with dementia during COVID-19 pandemic: protocol of a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Evaluating the effectiveness of a 6-week hybrid mindfulness-based intervention in reducing the stress among caregivers of patients with dementia during COVID-19 pandemic: protocol of a randomized controlled trial.

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