Self-Care Training for Caregiver Stress

(MCP Trial)

Overseen By Rhiannon Ueberholz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Toronto Metropolitan University

Disqualifiers: Mindfulness practice, PTSD, Substance disorder, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

232 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for reducing caregiver stress?

Research shows that mindfulness and compassion practices can effectively reduce stress, improve emotional regulation, and enhance self-care in healthcare settings. Mindfulness training has also been found to alleviate psychological distress and improve quality of life in chronic illness management, and a pilot study demonstrated its feasibility and effectiveness in improving mindfulness among caregivers of veterans. ^{1 2 3 4 5}

Is mindfulness-based stress reduction safe for caregivers?

Mindfulness-based stress reduction and similar mindfulness practices have been shown to be safe for caregivers, with studies indicating improvements in stress, anxiety, and overall well-being without significant safety concerns. ^{5 6 7 8 9}

How does the treatment for caregiver stress differ from other treatments?

This treatment is unique because it combines mindfulness meditation and psychoeducation to help caregivers manage stress, which is different from traditional treatments that may not focus on mindfulness. Mindfulness meditation helps caregivers become more aware of their thoughts and feelings, potentially reducing stress and improving resilience, while psychoeducation provides them with knowledge and skills to better handle caregiving challenges. ^{10 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to assess whether an 8-week mindfulness program enhances psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability) in primary family caregivers of persons with dementia or a related neurodegenerative disease. A total of 232 primary family caregivers aged 50+ years of age will be recruited for this study and randomized to one of three groups: mindfulness meditation (MM), psychoeducation (PSY) or caregiver respite (CR). All participants will complete three testing sessions: baseline (pre-intervention \[T1\]), post 8-week follow-up (post-intervention, \[T2\]), and 12-month follow-up (T3).

Research Team

Alexandra Fiocco, PhD

Principal Investigator

Toronto Metropolitan University

Eligibility Criteria

This trial is for primary family caregivers aged 50 or older who are caring for someone with dementia or a similar disease. They must speak English fluently and be able to attend all sessions. Caregivers already practicing mindfulness, those with PTSD, substance disorders, psychosis, or without computer/internet access cannot participate.

Inclusion Criteria

Currently a primary family caregiver

I am 50 years old or older.

Fluent in English

Exclusion Criteria

I am not open to being randomly assigned to a treatment group.

I have been diagnosed with psychosis.

No access to a computer or high-speed internet

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week program, either mindfulness meditation, psychoeducation, or receive respite care

8 weeks

8 virtual sessions (via Zoom), weekly

Post-intervention Follow-up

Participants are assessed for psychological well-being, biological stress indicators, and cognitive function

1 week

1 visit (virtual)

Long-term Follow-up

Participants are monitored for long-term effects on psychological well-being, biological stress indicators, and cognitive function

12 months

1 visit (virtual)

Treatment Details

Interventions

• Mindfulness Meditation
• Psychoeducation
• Wait list control

Trial Overview The study tests if an 8-week mindfulness meditation program can reduce stress and improve mood and cognitive function in caregivers compared to psychoeducation and respite care. Participants will be randomly assigned to one of these three groups and evaluated over a year.

Participant Groups

Group I: Mindfulness Meditation (MM) Experimental Treatment 1 Intervention

8-week mindfulness meditation program is based on Kabat-Zinn's MBSR program and will be led by MBSR-trained facilitators. The program has been modified to make it more accessible to caregivers. Weekly sessions will be 120-minutes long (instead of original 150-180-minute sessions). Formal meditation practices described in the original MBSR program (i.e., body scan, sitting meditation, mindful movement, mindful eating and walking) will be taught, in addition to loving kindness meditation (LKM). Participants will be given guided meditation recordings and compliance with home practice will be monitored with a practice log. The prescribed home practice has been modified to accommodate the needs of the caregiver: each practice is offered in 5- to 10-minute intervals (5 min, 10 min, and 20 min practice) to accommodate the caregiver's schedule.

Group II: Psychoeducation Active Control 1 Intervention

Psychoeducation (PSY) condition will be similar to MM with respect to number and duration of weekly sessions and daily homework. PSY is a lecture-based program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. Each session focuses on a specific topic related to wellness (e.g., nutrition, physical activity, medical screening) and caregiver-specific topics (e.g., understanding dementia and neurodegenerative disease, legal and financial issues).

Group III: Respite control Active Control 1 Intervention

Participant allocated to RC will not be exposed to a program, but will be offered 120-minutes of weekly respite care. Caregivers will be asked to record how they spend respite hours each week.

Who Is Running the Clinical Trial?

Toronto Metropolitan University

Lead Sponsor

Trials

95

Recruited

19,300+

Findings from Research

Mindfulness training, which includes group instruction in various meditation styles, helps individuals focus on their present experiences without being overwhelmed by negative thoughts.

There is growing evidence that incorporating mindfulness training into chronic disease management can reduce psychological distress and enhance the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training: an adjunctive role in the management of chronic illness? Monshat, K., Castle, DJ.[2019]

An 8-week mindfulness-based intervention for caregivers of veterans was found to be feasible and well-accepted, with 100% retention of participants throughout the study.

The intervention led to significant improvements in four out of five facets of mindfulness compared to a waitlist control group, indicating its effectiveness in enhancing mindfulness among caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Mindfulness-Based Intervention for Caregivers of Veterans: A Pilot Study. Lara-Cinisomo, S., Fujimoto, EM., Santens, RL.[2020]

An eight-week mindfulness-based stress reduction (MBSR) program significantly reduced perceived stress and mood disturbance in family caregivers of individuals with Alzheimer's disease compared to a standard social support (SS) group, based on a pilot study with 38 participants.

While both MBSR and SS led to improvements in psychosocial outcomes at a three-month follow-up, there were no lasting differences in stress reduction or cortisol response between the two groups, suggesting that both interventions may contain effective elements for caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia. Brown, KW., Coogle, CL., Wegelin, J.[2022]

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]

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]

An 8-week online mindfulness meditation program for 40 community-dwelling older adult caregivers significantly reduced caregiver burden, perceived stress, anxiety, and loneliness, while improving mental well-being.

The high retention rate of 55% indicates that online interventions are a feasible and flexible option for caregivers, allowing them to participate despite their responsibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Online Mindfulness Intervention to Decrease Caregiver Burden and Improve Psychological Well-Being. Tkatch, R., Bazarko, D., Musich, S., et al.[2019]

A 6-week mindfulness-based resilience training (MBRT) program for 31 transplant patients and 18 caregivers led to significant improvements in perceived stress, depression, anxiety, and negative affect, with results measured at 6 weeks and 3 months post-intervention.

Participants reported enhanced quality of life and positive affect, indicating that MBRT is a promising intervention for improving well-being and resilience in transplant patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A resilience intervention involving mindfulness training for transplant patients and their caregivers. Stonnington, CM., Darby, B., Santucci, A., et al.[2018]

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]

A proof-of-concept study involving six medical students showed that a hybrid model of free online mindfulness-based stress reduction training combined with peer facilitation is feasible, with six out of seven participants completing at least half of the sessions.

Participants reported positive changes in perceived stress, mindfulness, resilience, and confidence in providing compassionate care, suggesting that this approach could be effective, though further research is needed to evaluate its impact more formally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group online mindfulness training: proof of concept. Kemper, KJ., Yun, J.[2022]

A study involving 40 medical residents showed that teaching sessions on caregiver stress significantly improved their knowledge, particularly regarding the costs of caregiving, physical stress, and identifying elder abuse, as evidenced by higher posttest scores.

The residents rated the teaching intervention highly, suggesting that integrating caregiver stress education into primary care residency programs could enhance future healthcare providers' understanding and support for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing and managing caregiver stress: development of a teaching tool for medical residents. Famakinwa, A., Fabiny, A.[2008]

This study will evaluate the effectiveness of a mindfulness-based intervention for 240 Chinese family caregivers of frail older adults, comparing it to an evidence-based psychoeducation program and standard treatment, focusing on various health and well-being measures.

The research aims to provide insights into how mindfulness can reduce caregiver burden and improve mental health outcomes, with follow-up assessments at six months to determine the lasting effects of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: A Study Protocol. Lo, HHM., Au, A., Cho, WV., et al.[2022]

The Balance Study, involving 78 family caregivers of individuals with dementia, found that mindfulness-based stress reduction (MBSR) significantly improved mental health, reduced stress, and decreased depression compared to community caregiver education and support (CCES).

Both MBSR and CCES were effective in enhancing caregiver mental health, but MBSR showed superior benefits, suggesting it could be a valuable intervention for caregivers dealing with the chronic stress of caring for a family member with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Whitebird, RR., Kreitzer, M., Crain, AL., et al.[2022]

The Central Meditation and Imagery Therapy for Caregivers (CMIT-C) program, an 8-week group therapy for dementia caregivers, was found to be feasible and effective, with significant reductions in anxiety, depression, and insomnia symptoms among participants.

Participants who engaged more in meditation practice during the first week showed greater improvements in anxiety and overall satisfaction, suggesting that early engagement may enhance the benefits of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of central meditation and imagery therapy for dementia caregivers. Jain, FA., Nazarian, N., Lavretsky, H.[2022]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Mindfulness training: an adjunctive role in the management of chronic illness? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Mindfulness-Based Intervention for Caregivers of Veterans: A Pilot Study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. [2023]

5. Sweden pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

A Pilot Online Mindfulness Intervention to Decrease Caregiver Burden and Improve Psychological Well-Being. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

A resilience intervention involving mindfulness training for transplant patients and their caregivers. [2018]

8. Canada 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Group online mindfulness training: proof of concept. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Assessing and managing caregiver stress: development of a teaching tool for medical residents. [2008]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: A Study Protocol. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Feasibility of central meditation and imagery therapy for dementia caregivers. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. [2021]