82 Participants Needed

Mindfulness Program for Caregiver Stress

(SOCIAL Trial)

AT
SG
MC
Overseen ByMaggie Crean, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

What data supports the effectiveness of the treatment Mindful and Self-Compassionate Care Program (MASC) for caregiver stress?

Research shows that mindfulness and self-compassion training can help reduce stress and improve resilience in caregivers, as seen in studies with caregivers of Alzheimer's patients and nurses. These programs have been associated with lower levels of depression, anxiety, and stress, suggesting that similar benefits might be expected from the MASC program.12345

What 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.678910

Is the Mindfulness Program for Caregiver Stress safe for participants?

Research on mindfulness-based programs, including Mindful Self-Compassion, suggests they are generally safe, but the potential for harm has not been comprehensively studied. Participants in these programs often report high satisfaction and improved well-being, but more research is needed to fully understand any risks.111121314

Is 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.115161718

How is the Mindful and Self-Compassionate Care Program (MASC) treatment different from other treatments for caregiver stress?

The Mindful and Self-Compassionate Care Program (MASC) is unique because it combines mindfulness practices with self-compassion techniques, which may enhance psychological resilience and reduce stress in caregivers. Unlike other treatments, it focuses on both mindfulness and self-compassion, potentially offering a more holistic approach to managing caregiver stress.115161718

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.

Research Team

Ana-Maria Vranceanu, Ph.D. | Mass ...

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

CR

Christine Ritchie, MD, MSPH

Principal Investigator

Massachusetts General Hospital

Eligibility 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
See 4 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)
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
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

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+

Findings from Research

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.
Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients.Ho, L., Bloom, PA., Vega, JG., 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.
Benefits of mindful self-compassion for frontline nurses.Biber, DD.[2023]
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.
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]

References

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. [2021]
Benefits of mindful self-compassion for frontline nurses. [2023]
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]
A Brief Mindfulness-Based Self-Care Curriculum for an Interprofessional Group of Palliative Care Providers. [2020]
CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. [2023]
Self-directed care: participants' service utilization and outcomes. [2018]
Randomized Controlled Trial of Self-Directed Care for Medically Uninsured Adults With Serious Mental Illness. [2023]
Economic grand rounds: a self-directed care model for mental health recovery. [2017]
Person-Centered Care for Older Adults With Serious Mental Illness and Substance Misuse Within a Program of All-Inclusive Care for the Elderly. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Exploring Personal Medicine as Part of Self-Directed Care: Expanding Perspectives on Medical Necessity. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Mindfulness Self-Compassion: Helping Family Caregivers Cope with Cognitive Behaviors of Dementia. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. [2023]
Psychophysiological stress response after a 6-week Mindful Self-Compassion training in psychiatric rehabilitation inpatients: a randomized post-test only study. [2023]
[Prevent burnout in health care with mindfulness and compassion]. [2019]
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]
16.United Statespubmed.ncbi.nlm.nih.gov
Perceptions of mindfulness practices as a support for individuals managing caregiving responsibilities and chronic disease: A qualitative study. [2023]
[Effectiveness of a mindfulness-based stress reduction program for family caregivers of people with dementia. Systematic review of randomised clinical trials]. [2020]
18.United Statespubmed.ncbi.nlm.nih.gov
An Online Mindfulness-based Intervention for Certified Nursing Assistants in Long-term Care. [2023]
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