An interventional study of Mindfulness-Based Stress Reduction and Self-Guided Mindfulness eCourse in Mindfulness Based Stress Reduction, Caregiver Burnout and Caregiver Stress Syndrome, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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.
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.
439 studies on the registry are indexed under Caregiver Burden; 154 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 346 interventional studies indexed under Caregiver Burden.
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Exclusion Criteria:
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.
Other: Mindfulness-Based Stress Reduction
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.
Other: Self-Guided Mindfulness eCourse
Eight MBSR sessions of 1.5 hours per week
Also known as: MBSR, Mindfulness Based Stress Reduction
Six weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist
Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) Score
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.
Time frame: Baseline, 21 weeks
Change in Short Form Zarit Burden Interview (ZBI-SF) Score
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.
Time frame: Baseline, 21 weeks
Change in Positive Aspects of Caregiving (PAC) Scale
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.
Time frame: Baseline, 21 weeks
Change Mutuality scale of the Family Care Inventory (FCI-MS) Score
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.
Time frame: Baseline, 21 weeks
Change in Interpersonal Reactivity Index Empathic Concern (IRI-PT) Score
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.
Time frame: Baseline, 21 weeks
Change in Interpersonal Reactivity Index Empathic Concern (IRI-EC) Score
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.
Time frame: Baseline, 21 weeks
Change in Interpersonal Reactivity Index Personal Distress (IRI-PD) Score
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.
Time frame: Baseline, 21 weeks
Change in Interpersonal Reactivity Index Fantasy (IRI-FS) Score
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.
Time frame: Baseline, 21 weeks
Change in Fears of Compassion Scale (FCS): Fear of Compassion for Others Subscale
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.
Time frame: Baseline, 21 weeks
Change in Fears of Compassion Scale (FCS): Fear of Compassion from Others Subscale
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.
Time frame: Baseline, 21 weeks
Change in The Awareness of Social Inference Task SIE (TASIT-SIE) Score
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.
Time frame: Baseline, 21 weeks
Change in Humor Picture Test Score
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.
Time frame: Baseline, 21 weeks
Change in Social Display Rules Task (SDR) Score
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.
Time frame: Baseline, 21 weeks
Change in Depression Anxiety Stress Scales 21 (DASS-21) Anxiety Scale
Anxiety symptom severity will be measured with change in the anxiety subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The DASS-21 consists of three 7-item subscales. Participants indicate how much each of 21 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Higher scores indicate higher levels of anxiety.
Time frame: Baseline, 21 weeks
Change in Depression Anxiety Stress Scales 21 (DASS-21) Stress Scale
Perceived stress severity will be measured with change in the stress subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The DASS-21 consists of three 7-item subscales. Participants indicate how much each of 21 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Higher scores indicate higher levels of perceived stress.
Time frame: Baseline, 21 weeks
Change in Depression Anxiety Stress Scales 21 (DASS-21) Depression Scale
The primary outcome of depression symptom severity will be measured with change in the depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The DASS-21 consists of three 7-item subscales. Participants indicate how much each of 21 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Higher scores indicate higher levels of depression.
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Non-acceptance Subscale
The Difficulties in Emotion Regulation (DERS) test was designed to assess participant's trait-level emotion regulation ability. Responses are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always). The non-acceptance sub-scale assesses nonacceptance of emotional responses. Scores range from 6 to 30, and higher values reflect greater difficulty with the measured domain.
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Goals Subscale
The Difficulties in Emotion Regulation-Short Form (DERS) test was designed to assess participant's trait-level emotion regulation ability. Responses are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always). The goals subscale assesses difficulty engaging in goal-directed behavior. Scores range from 6 to 30, and higher values reflect greater difficulty with the measured domain.
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Impulse Subscale
The Difficulties in Emotion Regulation (DERS) test was designed to assess participant's trait-level emotion regulation ability. Responses are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always). The impulse subscale assesses impulse control difficulties. Scores range from 6 to 30, and higher values reflect greater difficulty with the measured domain.
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Awareness Subscale
The Difficulties in Emotion Regulation (DERS) test was designed to assess participant's trait-level emotion regulation ability. Responses are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always). The awareness subscale assesses lack of emotional awareness. Scores range from 6 to 30, and higher values reflect greater difficulty with the measured domain.
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Strategies Subscale
The Difficulties in Emotion Regulation (DERS) test was designed to assess participant's trait-level emotion regulation ability. Responses are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always). The strategies subscale assesses limited access to emotion regulation strategies. Scores range from 6 to 30, and higher values reflect greater difficulty with the measured domain.
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Clarity Subscale
The Difficulties in Emotion Regulation (DERS) test was designed to assess participant's trait-level emotion regulation ability. Responses are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always). The clarity subscale assesses lack of emotional clarity. Scores range from 6 to 30, and higher values reflect greater difficulty with the measured domain.
Time frame: Baseline, 21 weeks
Change in Scale of Positive and Negative Experiences (SPANE) PA Subscale Score
The Scale of Positive and Negative Experiences is 12-item self-report measure that will be used to measure a component of subjective well-being, one's positive affect. The subscale ranges from 6 to 30. Higher scores indicate greater experiences of positive affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions).
Time frame: Baseline, 21 weeks
Change in Caregiver Self-Efficacy Score
A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy.
Time frame: Baseline, 21 weeks
Change in Five Facets Mindfulness Questionnaire (FFMQ) Score
The FFMQ is a 15-item self-reported, instrument assessing mindfulness based on five factors that represent elements of mindfulness ( observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Possible scores range from 1 (never or very rarely true) to 5 (very often or always true).
Time frame: Baseline, 21 weeks
Change in Fears of Compassion Scale (FCS): Fear of Compassion for Self Subscale
This scale is comprised of 15 items and assesses the compassion we have for ourselves when we make mistakes or things go wrong in our lives. Scores range from 0 to 60. Higher scores indicate greater fear of compassion for self.
Time frame: Baseline, 21 weeks
Change in Self Compassion Scale Short Form (SCS-SF) Score
Self Compassion Scale Short Form (SCS-SF) total score, a 12-item self-report measure of self-compassion. The test answers on a Likert scale from 1 to 5, and scores range 12-60 with higher scores indicating greater self compassion.
Time frame: Baseline, 21 weeks
Change in Hedonic and Eudaimonic Motives for Activities Revised (HEMA-R) Scale
The HEMA scale is a 10-item questionnaire assessing the extent to which someone values happiness and pleasure versus seeking self-growth, and is measured on a 7-point Likert scale from "not at all" to "very much" for a composite score ranging from 7 to 70. Higher scores indicate better perceived psychological wellbeing.
Time frame: Baseline, 21 weeks
Change in WHO Quality of Life BREF (WHOQOL BREF) Score
WHOQOL BREF questionnaire consists of 26 items exploring physical health (7 items), psychological health (6 items), social relations (3 items), environment (8 items) and the quality of life related to health attesting to the overall satisfaction (2 items). Subject responses are collected using a Likert scale, scored from 1 to 5, summed and converted to a scale of 0 (poor quality of life) to 100 (good quality of life). Higher scores indicate better personal quality of life.
Time frame: Baseline, 21 weeks
Change in Pleasant Events Schedule (PES-AD) Score
The Pleasant Events Schedule (PES) will be used to measure the frequency with which the patient engages in enjoyable events. For each of 20 events, caregivers denote the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) with which the patient engaged in the event, and whether the patient enjoyed the event. Higher scores indicate higher frequency and pleasantness of activities.
Time frame: Baseline, 21 weeks
Plan to share: No
Ran from Aug 2021 to primary completion in Apr 2022, 7 months.
Of 253 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's 7 months is below that.
Counting every sponsor, half of 261 studies reached it within 16 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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