Clinical trial NCT04977245: Mindfulness-Based Stress Reduction in Dementia Caregivers
Official title: Mindfulness-Based Stress Reduction Intervention in Caregivers of Dementia Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness Based Stress Reduction
Caregiver Burnout
Caregiver Stress Syndrome
Dementia
Dementia Frontal
Frontotemporal Dementia
Frontotemporal Lobar Degeneration
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) Score
timeFrame: Baseline, 21 weeks
measure: Change in Short Form Zarit Burden Interview (ZBI-SF) Score
timeFrame: Baseline, 21 weeks
measure: Change in Positive Aspects of Caregiving (PAC) Scale
timeFrame: Baseline, 21 weeks
measure: Change Mutuality scale of the Family Care Inventory (FCI-MS) Score
timeFrame: Baseline, 21 weeks
measure: Change in Interpersonal Reactivity Index Empathic Concern (IRI-PT) Score
timeFrame: Baseline, 21 weeks
measure: Change in Interpersonal Reactivity Index Empathic Concern (IRI-EC) Score
timeFrame: Baseline, 21 weeks
measure: Change in Interpersonal Reactivity Index Personal Distress (IRI-PD) Score
timeFrame: Baseline, 21 weeks
measure: Change in Interpersonal Reactivity Index Fantasy (IRI-FS) Score
timeFrame: Baseline, 21 weeks
measure: Change in Fears of Compassion Scale (FCS): Fear of Compassion for Others Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Fears of Compassion Scale (FCS): Fear of Compassion from Others Subscale
timeFrame: Baseline, 21 weeks
measure: Change in The Awareness of Social Inference Task SIE (TASIT-SIE) Score
timeFrame: Baseline, 21 weeks
measure: Change in Humor Picture Test Score
timeFrame: Baseline, 21 weeks
measure: Change in Social Display Rules Task (SDR) Score
timeFrame: Baseline, 21 weeks
Secondary outcomes:
measure: Change in Depression Anxiety Stress Scales 21 (DASS-21) Anxiety Scale
timeFrame: Baseline, 21 weeks
measure: Change in Depression Anxiety Stress Scales 21 (DASS-21) Stress Scale
timeFrame: Baseline, 21 weeks
measure: Change in Depression Anxiety Stress Scales 21 (DASS-21) Depression Scale
timeFrame: Baseline, 21 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS): Non-acceptance Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS): Goals Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS): Impulse Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS): Awareness Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS): Strategies Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS): Clarity Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Scale of Positive and Negative Experiences (SPANE) PA Subscale Score
timeFrame: Baseline, 21 weeks
measure: Change in Caregiver Self-Efficacy Score
timeFrame: Baseline, 21 weeks
measure: Change in Five Facets Mindfulness Questionnaire (FFMQ) Score
timeFrame: Baseline, 21 weeks
measure: Change in Fears of Compassion Scale (FCS): Fear of Compassion for Self Subscale
timeFrame: Baseline, 21 weeks
measure: Change in Self Compassion Scale Short Form (SCS-SF) Score
timeFrame: Baseline, 21 weeks
measure: Change in Hedonic and Eudaimonic Motives for Activities Revised (HEMA-R) Scale
timeFrame: Baseline, 21 weeks
measure: Change in WHO Quality of Life BREF (WHOQOL BREF) Score
timeFrame: Baseline, 21 weeks
Other outcomes:
measure: Change in Pleasant Events Schedule (PES-AD) Score
timeFrame: Baseline, 21 weeks
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Katherine P Rankin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Luberto CM, Shinday N, Song R, Philpotts LL, Park ER, Fricchione GL, Yeh GY. A Systematic Review and Meta-analysis of the Effects of Meditation on Empathy, Compassion, and Prosocial Behaviors. Mindfulness (N Y). 2018 Jun;9(3):708-724. doi: 10.1007/s12671-017-0841-8. Epub 2017 Oct 23.