Mindfulness-Based Stress Reduction Intervention in Caregivers of Dementia Patients: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mindfulness Based Stress Reduction
- Sponsor
- University of California, San Francisco
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Fears of Compassion Scale (FCS): Fear of Compassion from Others Subscale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Fears of Compassion Scale (FCS): Fear of Compassion from Others Subscale
Time Frame: Baseline, 21 weeks
This scale is comprised of 13 items the compassion that we experience from others and flowing into the self. Scores range from 0 to 52. Higher scores indicate greater fear of compassion from others.
Change in The Awareness of Social Inference Task SIE (TASIT-SIE) Score
Time Frame: Baseline, 21 weeks
The TASIT test asks participants to watch 16 brief videos of social interactions, and answer 4 "Yes" or "No" questions per video. Answering these questions requires the ability to make inferences based on sarcasm, facial expressions, and other social elements seen in the videos, and measures socioemotional sensitivity. Higher scores indicate better ability to make real-world social inferences.
Change in Humor Picture Test Score
Time Frame: Baseline, 21 weeks
The Humor Picture test presents 8 different scenarios each with 4 potentially humorous outcomes that may be correct funny, straightforward, humorous nonsequitur, or unrelated nonsequitur, and is used to measure humor comprehension. Responses to each of the 4 categories are added together to allow 0-8 points in each category.
Change in Social Display Rules Task (SDR) Score
Time Frame: Baseline, 21 weeks
The SDR task presents 20 hypothetical social scenarios, and asks participants how they should respond to the scenario on a scale ranging from negative to positive responses with 0, 1, or 2 points awarded depending on the response. The test is used to evaluate knowledge of emotional social norms, and scores range from 0 to 40.
Change in Interpersonal Reactivity Index Empathic Concern (IRI-EC) Score
Time Frame: Baseline, 21 weeks
The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well). The empathetic concern scale assesses the extent of individuals' concern and compassion for others. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater amount of empathy for others.
Change in Interpersonal Reactivity Index Personal Distress (IRI-PD) Score
Time Frame: Baseline, 21 weeks
The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well). The personal distress subscale assesses individuals anxiety as a result of other's negative experiences. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater amount of personal distress for others' negative situations.
Change in Interpersonal Reactivity Index Fantasy (IRI-FS) Score
Time Frame: Baseline, 21 weeks
The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well).The fantasy subscale assesses the extent to which individuals identify with fictional characters. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater ability to identify with fictional characters.
Change in Fears of Compassion Scale (FCS): Fear of Compassion for Others Subscale
Time Frame: Baseline, 21 weeks
This scale is comprised of 10 items and assesses the compassion we feel for others, related to our sensitivity to other people's thoughts and feelings. Scores range from 0 to 40. Higher scores indicate greater fear of compassion for others.
Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) Score
Time Frame: Baseline, 21 weeks
The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Scores range 15-75, and higher scores indicate greater levels of experiential avoidance.
Change in Short Form Zarit Burden Interview (ZBI-SF) Score
Time Frame: Baseline, 21 weeks
The Zarit Burden Interview (ZBI) assess the stresses experienced by caregivers of patients with dementia. The short form assesses 12 questions about the impact of the patient's disabilities on the caregiver's life, each rated from least (0) to most (4) frequent. Items are summed to calculate the ZBI total score. The ZBI total score ranges from 0 to 48; higher scores denoting more stresses experienced by caregivers.
Change in Positive Aspects of Caregiving (PAC) Scale
Time Frame: Baseline, 21 weeks
The Positive Aspects of Caregiving Scale asks caregivers to rate their agreement/disagreement with 9 statements about positive aspects of caregiving on a 5-point Likert scale from "disagree a lot" to "agree a lot." Scores can range from 9 to 45 with higher scores indicating more subjective positive aspects of providing care to someone.
Change Mutuality scale of the Family Care Inventory (FCI-MS) Score
Time Frame: Baseline, 21 weeks
The Mutuality Scale of the Family Care Inventory will be used for rating mutual concerns and overall relationship satisfaction. The measure consists of 15 items. Scores range from 0-60, higher scores indicate greater relationship satisfaction.
Change in Interpersonal Reactivity Index Empathic Concern (IRI-PT) Score
Time Frame: Baseline, 21 weeks
The Interpersonal Reactivity Index (IRI) was designed to assess empathy, and has 28 items on a 5-point Likert scales (1 = does not describe me well to 5 = describes me very well). The perspective-taking scale assesses the extent to which individuals are able to take on others' points of view. Each of the 4 sub-scales has 7 items and scores range from 7 to 35. Higher scores indicate a greater ability to take on the perspective of other persons in social contexts.
Secondary Outcomes
- Change in Depression Anxiety Stress Scales 21 (DASS-21) Stress Scale(Baseline, 21 weeks)
- Change in Depression Anxiety Stress Scales 21 (DASS-21) Anxiety Scale(Baseline, 21 weeks)
- Change in Depression Anxiety Stress Scales 21 (DASS-21) Depression Scale(Baseline, 21 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS): Non-acceptance Subscale(Baseline, 21 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS): Goals Subscale(Baseline, 21 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS): Impulse Subscale(Baseline, 21 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS): Awareness Subscale(Baseline, 21 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS): Strategies Subscale(Baseline, 21 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS): Clarity Subscale(Baseline, 21 weeks)
- Change in Scale of Positive and Negative Experiences (SPANE) PA Subscale Score(Baseline, 21 weeks)
- Change in Caregiver Self-Efficacy Score(Baseline, 21 weeks)
- Change in Five Facets Mindfulness Questionnaire (FFMQ) Score(Baseline, 21 weeks)
- Change in Fears of Compassion Scale (FCS): Fear of Compassion for Self Subscale(Baseline, 21 weeks)
- Change in Self Compassion Scale Short Form (SCS-SF) Score(Baseline, 21 weeks)
- Change in Hedonic and Eudaimonic Motives for Activities Revised (HEMA-R) Scale(Baseline, 21 weeks)
- Change in WHO Quality of Life BREF (WHOQOL BREF) Score(Baseline, 21 weeks)