Mindfulness Program for Caregiver Stress

(SOCIAL Trial)

Overseen By Maggie Crean, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Depression, Anxiety

Disqualifiers: Mindfulness apps, Meditation, PMSQ ≥ 4, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers of individuals with Alzheimer’s and similar conditions manage stress more effectively. It introduces a new program called Mindful and Self-Compassionate Care (MASC), which teaches mindfulness, self-compassion, and behavior management skills. Participants will attend virtual group sessions and practice these skills at home. The trial suits those who live with and care for someone with dementia, have been doing so for more than six months, and experience stress in this role. As an unphased trial, it offers a unique opportunity to learn valuable skills that can enhance caregiver well-being.

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've recently changed medications for depression or anxiety in the past 6 weeks.

What prior data suggests that the Mindful and Self-Compassionate Care Program (MASC) is safe for caregivers of persons with Alzheimer Disease and Related Dementias?

Research shows that the Mindful and Self-Compassionate Care Program (MASC) helps caregivers manage stress by teaching skills like mindfulness and self-compassion. Although detailed safety information isn't available, mindfulness and self-compassion practices are generally safe and easy to tolerate.

Mindfulness programs typically include meditation and awareness exercises, which are gentle and pose few physical risks. Many participants find these practices calming and effective for stress reduction. Previous studies have shown that caregivers are interested in these programs to manage the stress of caring for loved ones with Alzheimer's and similar conditions.

In summary, even without specific safety details, mindfulness and self-compassion programs have a strong track record of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindful and Self-Compassionate Care Program (MASC) for caregiver stress because it offers a fresh approach that combines mindfulness, self-compassion, and behavioral management skills. Unlike traditional methods that often focus solely on stress management or physical health, MASC encourages caregivers to integrate mindfulness and self-compassion into their daily routines, potentially leading to longer-lasting mental health benefits. This holistic approach not only aims to alleviate stress but also promotes a more compassionate self-view, which is crucial for caregivers who frequently overlook their own well-being.

What evidence suggests that the Mindful and Self-Compassionate Care Program (MASC) could be effective for managing caregiver stress?

Research shows that mindfulness and self-compassion programs can reduce stress and improve emotional well-being for caregivers. In this trial, participants in the Mindful and Self-Compassionate Care Program (MASC) arm will engage in such a program. Earlier studies found that caregivers in similar programs reported feeling less stressed and better prepared for caregiving challenges. These programs, which combine mindfulness with self-compassion, have also shown promise in helping caregivers cope more effectively. Caregivers often face high stress due to their responsibilities, and these skills can help manage that stress more effectively. ^{1 5 6 7 8}

Who Is on the Research Team?

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Christine Ritchie, MD, MSPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in six virtual group sessions teaching mindfulness, self-compassion, and behavioral management skills, with at-home practice to integrate these skills.

6-8 weeks

6 virtual group sessions

Follow-up

Participants are monitored for feasibility, stress, anxiety, and well-being post-intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindful and Self-Compassionate Care Program (MASC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Mindful and Self-Compassionate Care Program (MASC) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A randomized controlled trial is underway to assess the feasibility and effectiveness of the Healthy Minds Program (HMP) mobile app in reducing stress and emotional distress among caregivers of individuals with Alzheimer's disease and related dementias, with 80 caregivers expected to participate over 12 weeks.

Preliminary enrollment has begun, with 27 caregivers enrolled as of June 2023, indicating the potential for HMP to be a cost-effective intervention that improves caregiver health and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Woodworth, EC., Briskin, EA., Plys, E., et al.[2023]

The Florida Self-Directed Care (FloridaSDC) program, which serves individuals with severe mental illness, allows participants to manage their own care budgets, leading to modest improvements in their functional assessment scores while they remained in the community.

Despite low income and limited employment among participants, their ability to make personalized service choices did not negatively impact their outcomes, suggesting that self-directed care can be effective in supporting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-directed care: participants' service utilization and outcomes. Spaulding-Givens, JC., Lacasse, JR.[2018]

A feasibility study involving 19 certified nursing assistants (CNAs) in long-term care settings showed that an online mindfulness-based intervention (MBI) significantly reduced depressive symptoms, with a moderate effect size (d = 0.47).

Out of the initial participants, 68% completed the intervention, suggesting that MBIs could be a promising approach to improve job satisfaction and reduce burnout among CNAs, warranting further research with a larger group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Online Mindfulness-based Intervention for Certified Nursing Assistants in Long-term Care. Young, CC., Kesler, S., Walker, VG., et al.[2023]

Self-directed care (SDC) significantly improved outcomes for low-income individuals with serious mental illness, including greater perceived competence in self-management, better recovery from symptoms, and increased employment compared to traditional services.

Despite the enhanced outcomes, SDC did not lead to higher service costs, indicating that it can be a cost-effective alternative to standard mental health care while maintaining high user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Self-Directed Care for Medically Uninsured Adults With Serious Mental Illness. Cook, JA., Jonikas, JA., Burke-Miller, JK., et al.[2023]

The mindfulness-based stress reduction program (MBSR) has been shown to effectively reduce anxiety, depression, and caregiver overload symptoms in family caregivers of people with dementia, based on a review of 5 randomized trials involving 309 participants.

While MBSR demonstrated positive effects immediately after the program, some studies indicated that these benefits may diminish over time, highlighting the need for further research to establish consistent protocols and long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of a mindfulness-based stress reduction program for family caregivers of people with dementia. Systematic review of randomised clinical trials]. Grandi, F., Burgueño, L., Irurtia, MJ.[2020]

Programs of All-Inclusive Care for the Elderly (PACE) are effectively positioned to provide integrated, person-centered care for older adults with co-occurring serious mental illness and substance misuse, addressing their complex medical and emotional needs.

A case study highlighted the importance of understanding the impact of trauma on the mental health and substance use of dual-diagnosis patients, emphasizing the need for tailored care strategies within the PACE model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Person-Centered Care for Older Adults With Serious Mental Illness and Substance Misuse Within a Program of All-Inclusive Care for the Elderly. Cacchione, PZ., Eible, L., Gill, LL., et al.[2018]

An 8-week mindfulness-based stress reduction (MBSR) training course significantly improved psychological resilience in non-professional caregivers of Alzheimer's patients, indicating its potential as an effective intervention for caregiver stress.

The study identified specific biomarkers in blood that predict which caregivers are likely to benefit from MBSR, providing insights into the mechanisms behind its health benefits and paving the way for personalized approaches in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. Ho, L., Bloom, PA., Vega, JG., et al.[2021]

A study involving 16 participants with chronic diseases and their caregivers revealed that mindfulness programs could effectively reduce stress related to disease management, highlighting the importance of addressing the unique stressors faced by this population.

Participants expressed a need for mindfulness programs to be tailored to their specific circumstances, suggesting that culturally relevant instruction and accessible formats could enhance participation and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of mindfulness practices as a support for individuals managing caregiving responsibilities and chronic disease: A qualitative study. West, NT., Harmon, BE., Rawlett, KE., et al.[2023]

A brief mindfulness-based curriculum delivered in five one-hour sessions was feasible and well-received by 29 palliative care providers, leading to significant improvements in mindfulness and mindfulness practices that were maintained for seven months.

While participants reported lower burnout levels than national averages, there was no significant change in burnout over the study period, suggesting that while mindfulness training is beneficial, it may not directly reduce burnout in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Mindfulness-Based Self-Care Curriculum for an Interprofessional Group of Palliative Care Providers. Podgurski, L., Greco, C., Croom, A., et al.[2020]

Written emotional disclosure showed a significant short-term reduction in caregiver burden, as measured by the Zarit Caregiver Burden Index, with a decline of -4.21 points at week 4 compared to control, although this effect diminished by week 8.

While overall distress and quality of life worsened for all groups, the written emotional disclosure group experienced the least worsening, suggesting it may be a beneficial strategy for managing caregiver distress in the context of advanced liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Tapper, EB., Saleh, ZM., Lizza, S., et al.[2023]

While mindfulness-based programs (MBPs) are known for their benefits, the potential for harm has not been thoroughly investigated, indicating a need for more research in this area.

The study identifies three key factors that may contribute to harm in MBPs: program-related factors, participant-related factors, and clinician-related factors, suggesting that understanding these can help improve safety and effectiveness in future mindfulness practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. Baer, R., Crane, C., Miller, E., et al.[2023]

Mindfulness and compassion practices, such as focus and insight meditation, are effective in reducing stress among healthcare professionals, helping them manage emotional distress and improve emotional regulation.

Training in mindfulness and compassion can transform empathy into compassion, which may counteract empathy fatigue and enhance self-care, making group training in healthcare settings a beneficial approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevent burnout in health care with mindfulness and compassion]. Yu, W.[2019]

Participants in a self-directed care program showed significant improvements in their recovery, spending less time in psychiatric inpatient and criminal justice settings after enrollment compared to the year before.

The program allowed participants to control approximately $58,000 in funds, with nearly half spent on traditional psychiatric services, indicating a preference for conventional care while also exploring alternative supports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic grand rounds: a self-directed care model for mental health recovery. Cook, JA., Russell, C., Grey, DD., et al.[2017]

In a study involving 60 participants with serious mental illness, self-directed care (SDC) allowed individuals to make 507 requests for nontraditional goods and services, highlighting their need for personalized support beyond conventional mental health services.

The most common requests focused on self-care and general tasks, indicating that SDC can empower individuals to address unmet needs and utilize personal-medicine strategies effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Personal Medicine as Part of Self-Directed Care: Expanding Perspectives on Medical Necessity. Snethen, G., Bilger, A., Maula, EC., et al.[2018]

An 8-week compassion cultivation training (CCT) program significantly reduced psychological distress in caregivers of individuals with mental illness, with 161 participants assessed over 6 months.

Key mediators of this reduction included self-compassion and mindfulness, which were shown to effectively lower levels of depression, anxiety, and stress among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators for the Effect of Compassion Cultivating Training: A Longitudinal Path Analysis in a Randomized Controlled Trial Among Caregivers of People With Mental Illness. Hansen, NH., Fjorback, LO., Frydenberg, M., et al.[2021]

Nurses who practice mindful self-compassion (MSC) training are likely to experience greater resilience against stress and burnout, which can enhance their ability to provide compassionate care to patients.

The article reviews the effectiveness of an MSC curriculum and offers practical techniques for nurses to implement MSC strategies in their daily routines, promoting both their well-being and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of mindful self-compassion for frontline nurses. Biber, DD.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11512127/

Protocol for the Mindful and Self-Compassion Care ... The first program that combines mindfulness and self-compassion with behavioral management skills to decrease caregiver stress.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39928550/

Development of a Mindfulness and Self-compassion (MASC ... Results: Qualitative analyses showed high stress in caregivers stemming from their care-recipients behavioral symptoms. Caregivers reported ...

3. researchprotocols.org researchprotocols.org/2024/1/e58356/PDF

Protocol for the Mindful and Self-Compassion Care A growing body of literature suggests that caregivers are at risk for decreased quality of life, increased depression as well as negative health ...

4. aging.jmir.org aging.jmir.org/2021/4/e28652/

An App-Based Mindfulness-Based Self-compassion Program ... Our primary outcome measure was caregiver burden, with secondary outcome measures including coping styles and emotional well-being. Daily ...

5. journals.lww.com journals.lww.com/nams/fulltext/2022/11020/the_effect_of_an_online_mindfulness.3.aspx

The Effect of an Online Mindfulness Self-Compassion... In summary, our results showed that an online MSC training program was effective in relieving psychological distress among family caregivers of patients with ...

6. researchprotocols.org researchprotocols.org/2024/1/e58356

Protocol for the Mindful and Self-Compassion Care ... The first program that combines mindfulness and self-compassion with behavioral management skills to decrease caregiver stress.

7. academic.oup.com academic.oup.com/gerontologist/article-abstract/doi/10.1093/geront/gnaf058/8006662

Development of a Mindfulness and Self-compassion (MASC ... Qualitative analyses showed high stress in caregivers stemming from their care-recipients behavioral symptoms. Caregivers reported interest in a program like ...

8. withpower.com withpower.com/trial/phase-caregiver-stress-2-2024-9e55f

Mindfulness Program for Caregiver Stress (SOCIAL Trial) The provided research does not contain specific safety data for the Mindfulness Program for Caregiver Stress or its variants like the Mindful and Self- ...