Mindfulness-Based Stress Reduction in Dementia Caregivers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2022-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aims: The study will contribute to our understanding of how the cultivation of caregiver mindfulness might improve their overall relational well-being (Primary Outcome), their psychological well-being (Secondary Outcome), and have an impact on dementia patients' lifestyles (Other Outcome). Overall, this study will investigate the idea that the fruits of mindfulness training can be leveraged by both the caregiver and the care-recipient, improving the quality of relationship by making their interactions more mutual, connected, empathic and positive. This study aims to additionally elucidate which facets of mindfulness account for caregiver's happiness and psychological well-being.

Sample: In this study 40 dementia caregivers will be recruited to participate; 20 will be allocated to the clinical intervention group (i.e., adapted MBSR for caregivers) and 20 to the active control group. Data will be collected pre-post the start of intervention, and at a 3 month follow up.

Future orientation: This study may contribute to evidence-based knowledge concerning the efficacy of mindfulness based interventions to support caregiver empowerment, via regaining relationship satisfaction and achieving greater equanimity in the face of stressors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mindfulness Based Dementia Care Study

NCT04062227

Caregiver Burnout

COMPLETED

Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers

NCT03910855

Stroke Stress Anxiety +1 more

COMPLETED NA

Meditation or Education for Alzheimer Caregivers

NCT00558402

Caregivers Alzheimer's Disease

COMPLETED PHASE2

The Effects of a Meditation Intervention on the Psychological Burden of Long-Term Care Professionals and Family Caregivers

NCT07188454

Burnout, Professional Caregivers Caregivers Burnout +1 more

COMPLETED NA

The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care

NCT00615082

Dementia Caregivers Stress

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Caring for a family member with dementia is a very challenging task. Caregiving is associated with a hodgepodge of challenges, including negative affect, burnout, social isolation, role challenges, as well as decreased relationship quality between the caregiver and the care recipient. These conditions are often sustained over time and can implicate significant detrimental effects on the caregiver's physical and mental health, as well as their overall well-being. Criticism and emotional over-involvement expressed by the family member toward the patient seem to positively relate to the levels of caregiver strain and to reflect poor relationship quality. Mindfulness cultivates skills of non-reactivity, acceptance and awareness, which may work in the opposite direction to reactive, non-skillful coping mechanisms and seem to enhance attributes connected with individual happiness. Adopting those skills might, thus, ameliorate caregiver relationship quality and contribute in reframing the caregiving experience as more meaningful and positive.

Criticism and reactivity can be relayed by the caregiver to the patient and thus negatively affect relational well-being in the caregivers (Primary Outcome). A potential counter mechanism involves the cultivation of mindfulness skills of awareness and non-reactivity. Broadening perspective without automatically reacting may be crucial for improving the perceived relationship quality between caregiver and demented patient. Despite studies claiming a role for meditation and dispositional mindfulness in social cognition domains, there is a noteworthy gap in the literature with regard to how exactly meditation and mindfulness facets are associated with specific social cognition domains - i.e., how the focus on the experience of the present moment affects the way people perceive and interact with each other. Accordingly, very little is known about the effects of mindfulness how it may affect relationship quality in patient-caregiver couples dyads.

This study will also evaluate the effect of mindfulness skill development on the overall happiness and psychological well-being of caregivers (Secondary Outcome). Mindfulness training can help caregivers of dementia patients to be more aware of their emotional states, by enabling them to better acknowledge and accept any stressful or negative experiences they may encounter. The cultivation of self-compassion through mindfulness may help caregivers to be more kind and understanding of their role in such experiences, thus fostering self-kindness and decreasing self-judgment. These skills (acceptance, awareness, self-compassion), in turn, may lead to a decrease in rumination and allow for a newfound, more constructive appreciation of positive experiences. Caregivers of dementia patients may gain a new perspective on their role as a caregiver, potentially resulting in increased positive affect and reframe of caregiving experience as more purposeful. As an additional outcome, investigators will further explore the impact of caregiver mindfulness cultivation on the care recipient's lifestyle, manifested as frequency of engagement in specific daily activities, and the observed level of pleasure the dementia patient receives from these daily activities.

This aim of this study is to contribute to evidence-based knowledge concerning the efficacy of mindfulness-based interventions to support caregiver empowerment via improved relationship satisfaction and equanimity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mindfulness Based Stress Reduction Caregiver Burnout Caregiver Stress Syndrome Dementia Dementia Frontal Frontotemporal Dementia Frontotemporal Lobar Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of 20 participants. Group 1 is the control arm (online, self-guided stress reduction course) and group 2 is the intervention arm (MBSR group.)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Due to the nature of this study, masking is not possible. Participants and researchers must be aware of which arm they are in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MBSR Intervention

The intervention group will take part in a group-based mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. This MBSR program will have a shortened session length of 1.5 hours compared to the traditional 2 hours, to reduce caregiver burden. Caregivers will be trained in meditation practices, like awareness of one's breath, body scan, and loving kindness meditation. Participants will also learn about mindfulness and stress theory, and have group discussions covering topics such as self-compassion.

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type OTHER

Eight MBSR sessions of 1.5 hours per week

Self-Guided Meditation eCourse

Participants in the active control group will participate in a self-guided, online program named GARDEN. The self guided material teaches skills about increasing the daily experience of positive emotion as a mechanism to assist with stress coping. The program consists of eight skills introduced and discussed over an eight week period.

Group Type ACTIVE_COMPARATOR

Self-Guided Mindfulness eCourse

Intervention Type OTHER

Six weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness-Based Stress Reduction

Eight MBSR sessions of 1.5 hours per week

Intervention Type OTHER

Self-Guided Mindfulness eCourse

Six weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MBSR Mindfulness Based Stress Reduction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult, 18 or older
* Caregiver for a patient with dementia in personal life and regular weekly contact with the demented patient
* English speaking
* Literate: is able to read course material
* Able to attend weekly classes online via Zoom
* Willing to be randomized and participate in one of two interventions

Exclusion Criteria

* Are regularly practicing mindfulness meditation, mindful yoga, or similar mindfulness activities
* Currently experiencing active trauma (PTSD - unresolved, or acute stress disorder) without professional psychological assistance
* Clinical diagnosis of dementia
* Diagnosed with psychotic disorder such as schizophrenia, schizoaffective disorder or bipolar disorder according to the Diagnostic and Statistical Manual-V (DSM-V), and under antipsychotic treatment
* Undergoing treatment for substance abuse
* Vision or hearing impairments that would keep them from adequately participating in the intervention
* Any prior formal training in MBSR
* Acute suicide plans as measured by the Patient Safety Screener

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes