Trial Summary
What is the purpose of this trial?Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.
The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.
Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.
Do I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you've had a recent change in prescribed medications for depression or anxiety within the past 6 weeks.
What data supports the idea that Mindfulness Program for Caregiver Stress is an effective treatment?
The available research shows that the Mindfulness Program for Caregiver Stress can be effective in reducing stress and improving resilience among caregivers. For example, a study on caregivers of Alzheimer's patients found that an 8-week mindfulness-based stress reduction course significantly improved their psychological resilience. Another study on caregivers of people with mental illness showed that mindfulness and self-compassion were important in reducing depression, anxiety, and stress over six months. These findings suggest that mindfulness programs can help caregivers manage their stress and improve their well-being.
12345What safety data exists for the Mindfulness Program for Caregiver Stress?
The provided research does not contain specific safety data for the Mindfulness Program for Caregiver Stress or its variants like the Mindful and Self-Compassionate Care Program (MASC). The studies focus on self-directed care models for mental health, which are not directly related to the mindfulness program in question.
678910Is the Mindful and Self-Compassionate Care Program (MASC) a promising treatment for caregiver stress?
Yes, the Mindful and Self-Compassionate Care Program (MASC) is a promising treatment for caregiver stress. Mindfulness-based programs, like MASC, have been shown to improve psychological resilience, reduce stress, anxiety, and depression, and enhance overall well-being for caregivers. These programs can be delivered in a cost-effective manner, such as through mobile apps, making them accessible and beneficial for caregivers of dementia patients.
111121314Eligibility Criteria
This trial is for caregivers of individuals with Alzheimer's Disease and Related Dementias (ADRD) who experience stress from their caregiving duties. It aims to help them manage this stress, including the challenges that come with difficult patient behaviors.Inclusion Criteria
English fluency and literacy
Must live with and care for an individual with ADRD
Must have been in a caregiver role for more than 6 months
+5 more
Exclusion Criteria
Recent change in psychotropic treatment for depression or anxiety
Involvement in another clinical trial for caregivers
A score >= 4 on the Portable Mental Status Questionnaire (PMSQ)
+2 more
Participant Groups
The trial tests a new program called MASC which teaches mindfulness, self-compassion, and behavioral management skills through group training. Its effectiveness will be compared to a Health Education Program in a pilot randomized controlled trial.
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful and Self-Compassionate Care Program (MASC)Experimental Treatment1 Intervention
The intervention arm will be comprised of:
Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills.
At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Group II: Health Education Program (HEP)Active Control1 Intervention
The control arm will be comprised of:
Six Virtual Group Sessions. The sessions will discuss caregiver stress, sleep hygiene, nutrition, and ways to stay physically active as a caregiver.
At Home Practice. After each group session, participants will have the opportunity to complete journal exercises that encourage them to integrate the health information that they learn into their daily lives.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
University of California, San FranciscoCollaborator
National Institute on Aging (NIA)Collaborator
References
Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. [2021]Caregiving for a dementia patient is associated with increased risk of psychological and physical health problems. We investigated whether a mindfulness-based stress reduction (MBSR) training course for caregivers that closely models the MBSR curriculum originally established by the Center of Mindfulness at the University of Massachusetts may improve the psychological resilience of non-professional caregivers of Alzheimer's disease patients. Twenty adult non-professional caregivers of dementia patients participated in an 8-week MBSR training course. Caregiver stress, depression, burden, grief, and gene expression profiles of blood mononuclear cells were assessed at baseline and following MBSR. MBSR training significantly improved the psychological resilience of some of the caregivers. We identified predictive biomarkers whose expression is associated with the likelihood of caregivers to benefit from MBSR, and biomarkers whose expression is associated with MBSR psychological benefits. Our biomarker studies provide insight into the mechanisms of health benefits of MBSR and a basis for developing a personalized medicine approach for applying MBSR for promoting psychological and cognitive resilience in caregivers of dementia patients.
Benefits of mindful self-compassion for frontline nurses. [2023]Nurses who regularly engage in self-compassion training may be more resilient to stressors and burnout, and thus able to provide more compassionate care to patients. The article explores the benefits and strategies of practicing mindful self-compassion (MSC) for nurses, reviews the effectiveness of an MSC curriculum, and discusses practical techniques for nurses to put MSC theory into practice.
Mediators for the Effect of Compassion Cultivating Training: A Longitudinal Path Analysis in a Randomized Controlled Trial Among Caregivers of People With Mental Illness. [2021]Background: There is a paucity of research on mediators of change, within compassion training programs. The aim was to investigate the mediators, of an 8-week compassion cultivation training (CCT) program, on the effect of psychological distress on caregivers of people with a mental illness. Method: Longitudinal path models in a randomized controlled trial (RCT). One hundred ninety-two participants were assessed for eligibility, and 161 participants were included into the trial and randomized. The main outcome was psychological distress measured by the Depression, Anxiety and Stress scale at 6 months. Mediators included self-compassion (SC), mindfulness (FM), emotion regulation (ER), emotion suppression (ES), and cognitive reappraisal (CR). Baseline, post, and 3- and 6-month follow-up measurements were collected. Results: The mediated effects for CCT are as follows: depression at 6 months: SC: -1.81 (95% CI: -3.31 to -0.31); FM: -1.98 (95% CI: -3.65 to -0.33); ER: -0.14 (95% CI: -1.31 to 1.02); anxiety at 6 months: SC: -0.71 (95% CI: -1.82 to 0.40); FM: -1.24 (95% CI: -2.39 to -0.09); ER: 0.18 (95% CI: -1.04 to 1.40); stress at 6 months: SC: -1.44 (95% CI: -2.84 to -0.05); FM: -2.17 (95% CI: -3.63 to -0.71); ER: -0.27 (95% CI: -1.51 to 0.98). Conclusion: Mindfulness and self-compassion are important components in reducing psychological distress experienced by informal caregivers of people with a mental illness. Results contribute to the knowledge about the underlying mechanisms of CCT.
A Brief Mindfulness-Based Self-Care Curriculum for an Interprofessional Group of Palliative Care Providers. [2020]Background: Mindfulness-based interventions for health care providers have shown benefits for provider wellbeing and for their patients, but established programs are time-intensive. Objective: To establish the feasibility of a brief mindfulness-based curriculum focused on self-care for an interprofessional group of palliative care providers within the regular workday, and to evaluate the effectiveness of the curriculum in improving the levels of burnout, mindfulness, use of mindfulness meditation practices, and stress levels. Design: Pre-, one-week post-, and seven-month post-intervention survey assessment. The intervention was conducted in five monthly one-hour sessions. Setting: Participants were 29 mixed-professional-background usual-attendees of a monthly educational conference in a well-established palliative care group within an academic medical center. Measurements: Paired, confidential assessments using validated scales (the Five Facet Mindfulness Questionnaire, the Maslach Burnout Inventory, the Ten-item Perceived Stress Scale), report of use of informal and formal mindfulness techniques, narrative data, and satisfaction ratings. Results: Participants reported high satisfaction with the series and showed statistically significant improvements in dimensions of mindfulness and mindfulness practices, sustained for seven months. Burnout levels in this group were much lower than reported national rates; no statistically significant change was seen in burnout over the study period. Narrative data demonstrated retention of curricular content. Conclusions: Delivery of a mindfulness-based self-care series to an interprofessional group of palliative care providers within the regular workday was feasible, well received, and associated with increased mindfulness levels, mindfulness practices, and knowledge.
CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. [2023]Patient caregivers experience burden and distress that negatively impacts health-related quality of life (HRQOL). Mindfulness may alleviate caregiver burden but randomized trials of mindfulness activities on caregiver burden and distress are lacking.
Self-directed care: participants' service utilization and outcomes. [2018]Self-directed care (SDC) is a mental health service delivery model in which participants budget the state dollars allotted for their care to purchase the goods and services they deem most appropriate for achieving their recovery goals. This study examines the demographic characteristics, service utilization patterns, and outcomes of individuals enrolled in the Florida Self-Directed Care (FloridaSDC) program, which is the oldest and most established SDC program in the United States for individuals diagnosed with a severe and persistent mental illness.
Randomized Controlled Trial of Self-Directed Care for Medically Uninsured Adults With Serious Mental Illness. [2023]Self-directed care (SDC) is a treatment model in which recipients self-manage funds designated for provision of services. The model is designed to cost no more than traditional services while achieving superior participant outcomes. The authors examined the model's impact on outcomes, service costs, and user satisfaction among medically uninsured, low-income individuals with serious mental illness.
Economic grand rounds: a self-directed care model for mental health recovery. [2017]Self-directed care programs give participants control over public funds to purchase services and supports for their own recovery. Data were examined for 106 individuals and showed that compared with the year before enrollment, in the year after enrollment, participants spent significantly less time in psychiatric inpatient and criminal justice settings and showed significantly better functioning. Of approximately $58,000 in direct expenditures by participants over 19 months of operation, 47% was spent on traditional psychiatric services, 13% on service substitutions for traditional care, 29% on tangible goods, 8% on uncovered medical care, and 3% on transportation. Early positive results of this pilot program support replication and evaluation elsewhere.
Person-Centered Care for Older Adults With Serious Mental Illness and Substance Misuse Within a Program of All-Inclusive Care for the Elderly. [2018]Providing person-centered care (PCC) to older adults with dual diagnosis, co-occurring serious mental illness (SMI), and substance misuse is complex and requires an interprofessional team. Older adults, who qualify for both Medicaid and Medicare (i.e., dual-eligibles) are overrepresented in the population of older adults with SMI and substance misuse. Programs of All-Inclusive Care for the Elderly (PACE) exist to support community living needs of nursing home-eligible older adults and are increasingly in a position to serve older adults with SMI and substance misuse issues. PACE programs provide integrated person-centered mental health care to address the serious medical, social, and emotional complications posed by having SMI and substance misuse disorders. The case study presented illustrates PCC provided to a dual-diagnosis PACE participant, illustrating the impact of recent and past trauma on current psychopathology and substance misuse. Finally, recommendations for addressing PCC of dual diagnosis within the PACE model are provided. [Journal of Gerontological Nursing, 42(5), 11-17.].
Exploring Personal Medicine as Part of Self-Directed Care: Expanding Perspectives on Medical Necessity. [2018]Self-directed care (SDC) offers flexibility in and control over mental health services. This study examined the types of goods and services that individuals with serious mental illness request in an SDC intervention.
Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial. [2023]Informal caregivers (ie, individuals who provide assistance to a known person with health or functional needs, often unpaid) experience high levels of stress. Caregiver stress is associated with negative outcomes for both caregivers and care recipients. Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer disease and related dementias (ADRD). Commercially available mobile mindfulness apps can deliver MBIs to caregivers of persons with ADRD in a feasible and cost-effective manner.
Perceptions of mindfulness practices as a support for individuals managing caregiving responsibilities and chronic disease: A qualitative study. [2023]Explore the lived experience of individuals managing and/or caregiving for someone with a chronic disease and their perceptions of developing a mindfulness program for stress reduction.
[Effectiveness of a mindfulness-based stress reduction program for family caregivers of people with dementia. Systematic review of randomised clinical trials]. [2020]Family caregivers of people with dementia usually have high levels of anxiety, depression, and overload symptoms, and are reasons for being considered a clinically vulnerable population. The objective of the present review is to examine the effectiveness of the mindfulness-based stress reduction program (MBSR) applied to this population. A search was made in the electronic databases for randomised trials with pre-post measurement in the last 15 years. The methodological quality was obtained using the Jadad scale. Finally, 5 articles were included, obtaining a sample of 309 participants. The score on the Jadad scale was 3.4 out of 5. In general, the MBSR program reduces anxiety and depression symptoms, as well as overload levels in the post-measurement. However, some studies showed a significant reduction in the psychological effects of the program during follow-up. More empirical studies are needed that can establish a more homogeneous protocol that reduces the ambiguity of some results.
An Online Mindfulness-based Intervention for Certified Nursing Assistants in Long-term Care. [2023]Purpose: Certified nursing assistants (CNAs) make up the largest segment of the long-term care (LTC) setting workforce, however, they are at high risk of job dissatisfaction and burnout. Evidence suggests that mindfulness-based interventions (MBIs) might be particularly relevant and useful for CNAs in reducing psychological distress, improving job satisfaction, and reducing burnout, but little research has investigated this possibility. A feasibility study of an online MBI for CNAs in LTC settings was therefore conducted. Methods: CNAs completed assessments at baseline and posttest. Paired t-tests assessed changes in mindfulness, psychological distress (i.e., depressive and anxiety symptoms, and stress), and professional quality of life. Results: Of the 19 CNAs who started the intervention, N = 13 (68%) completed it and provided postintervention data. Depressive symptoms were significantly decreased postintervention (F = 6.26, p = .036, d = .47). Conclusions: MBIs may have beneficial effects for CNAs in LTC settings. Further research with a larger CNA population will increase the power and relevance of these findings, ultimately contributing to the improvement of patient outcomes in LTC.