Mindfulness Based Stress ReductionMBSRNCT04977245
Mindfulness-Based Stress Reduction in Dementia Caregivers
A study testing Mindfulness-Based Stress Reduction and Self-Guided Mindfulness eCourse in people with Mindfulness Based Stress Reduction and Caregiver Burnout, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Based Stress Reduction, Caregiver Burnout, Caregiver Stress Syndrome
- What is being tested?
- Mindfulness-Based Stress Reduction and Self-Guided Mindfulness eCourse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco UCSF
San Francisco, California, 94158
About this study
Official title: Mindfulness-Based Stress Reduction Intervention in Caregivers of Dementia Patients: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Mindfulness Based Stress Reduction, Caregiver Burnout, Caregiver Stress Syndrome, Dementia, Dementia Frontal, Frontotemporal Dementia
- Being tested
- Mindfulness-Based Stress Reduction, Self-Guided Mindfulness eCourse
- Medical subject headings
- Caregiver Burden, Dementia, Frontotemporal Dementia, Frontotemporal Lobar Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionOther
Also called MBSR, Mindfulness Based Stress Reduction
Eight MBSR sessions of 1.5 hours per week
Self-Guided Mindfulness eCourseOther
Six weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist
| Study group | Role | What they receive |
|---|---|---|
| MBSR Intervention | Experimental | 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. Receives: Other: Mindfulness-Based Stress Reduction |
| Self-Guided Meditation eCourse | Active comparator | 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. Receives: Other: Self-Guided Mindfulness eCourse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 21 weeks
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start12 Aug 2021
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mindfulness Based Stress ReductionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine P Rankin, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977245
- Sponsor's protocol ID
- 20-31240
- Acronym
- MBSR
- Status last verified
- Apr 2022
- First submitted
- 15 Jul 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003 Jul-Aug;65(4):564-70. doi: 10.1097/01.psy.0000077505.67574.e3.
PubMed 12883106Garland EL, Farb NA, Goldin P, Fredrickson BL. Mindfulness Broadens Awareness and Builds Eudaimonic Meaning: A Process Model of Mindful Positive Emotion Regulation. Psychol Inq. 2015 Oct 1;26(4):293-314. doi: 10.1080/1047840X.2015.1064294. Epub 2015 Nov 24.
PubMed 27087765Lindsay EK, Creswell JD. Mechanisms of mindfulness training: Monitor and Acceptance Theory (MAT). Clin Psychol Rev. 2017 Feb;51:48-59. doi: 10.1016/j.cpr.2016.10.011. Epub 2016 Nov 5.
PubMed 27835764Li G, Yuan H, Zhang W. The Effects of Mindfulness-Based Stress Reduction for Family Caregivers: Systematic Review. Arch Psychiatr Nurs. 2016 Apr;30(2):292-9. doi: 10.1016/j.apnu.2015.08.014. Epub 2015 Aug 28.
PubMed 26992885Steadman PL, Tremont G, Davis JD. Premorbid relationship satisfaction and caregiver burden in dementia caregivers. J Geriatr Psychiatry Neurol. 2007 Jun;20(2):115-9. doi: 10.1177/0891988706298624.
PubMed 17548782Campos D, Modrego-Alarcon M, Lopez-Del-Hoyo Y, Gonzalez-Panzano M, Van Gordon W, Shonin E, Navarro-Gil M, Garcia-Campayo J. Exploring the Role of Meditation and Dispositional Mindfulness on Social Cognition Domains: A Controlled Study. Front Psychol. 2019 Apr 11;10:809. doi: 10.3389/fpsyg.2019.00809. eCollection 2019.
PubMed 31031678Luberto 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.
PubMed 30100929
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction Intervention in Caregivers of Dementia Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04977245
- Acronym / sponsor ID
- MBSR / 20-31240
- Conditions
- Mindfulness Based Stress Reduction, Caregiver Burnout, Caregiver Stress Syndrome, Dementia, Dementia Frontal, Frontotemporal Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.)
| Arm | Type | Receives |
|---|---|---|
| MBSR Intervention | Experimental | Other: Mindfulness-Based Stress ReductionThe 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. |
| Self-Guided Meditation eCourse | Active comparator | Other: Self-Guided Mindfulness eCourseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSR, Mindfulness Based Stress ReductionEight MBSR sessions of 1.5 hours per week | Other | MBSR Intervention |
| Self-Guided Mindfulness eCourseSix weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist | Other | Self-Guided Meditation eCourse |
Primary outcome
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.
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 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.
16 secondary outcomes
Change in Depression Anxiety Stress Scales 21 (DASS-21) Anxiety Scale
Time frame: Baseline, 21 weeks
Change in Depression Anxiety Stress Scales 21 (DASS-21) Stress Scale
Time frame: Baseline, 21 weeks
Change in Depression Anxiety Stress Scales 21 (DASS-21) Depression Scale
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Non-acceptance Subscale
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Goals Subscale
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Impulse Subscale
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Awareness Subscale
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Strategies Subscale
Time frame: Baseline, 21 weeks
Change in Difficulties in Emotion Regulation Scale (DERS): Clarity Subscale
Time frame: Baseline, 21 weeks
Change in Scale of Positive and Negative Experiences (SPANE) PA Subscale Score
Time frame: Baseline, 21 weeks
Change in Caregiver Self-Efficacy Score
Time frame: Baseline, 21 weeks
Change in Five Facets Mindfulness Questionnaire (FFMQ) Score
Time frame: Baseline, 21 weeks
Change in Fears of Compassion Scale (FCS): Fear of Compassion for Self Subscale
Time frame: Baseline, 21 weeks
Change in Self Compassion Scale Short Form (SCS-SF) Score
Time frame: Baseline, 21 weeks
Change in Hedonic and Eudaimonic Motives for Activities Revised (HEMA-R) Scale
Time frame: Baseline, 21 weeks
Change in WHO Quality of Life BREF (WHOQOL BREF) Score
Time frame: Baseline, 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 12883106Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003 Jul-Aug;65(4):564-70. doi: 10.1097/01.psy.0000077505.67574.e3.
- Background: PubMed 27087765Garland EL, Farb NA, Goldin P, Fredrickson BL. Mindfulness Broadens Awareness and Builds Eudaimonic Meaning: A Process Model of Mindful Positive Emotion Regulation. Psychol Inq. 2015 Oct 1;26(4):293-314. doi: 10.1080/1047840X.2015.1064294. Epub 2015 Nov 24.
- Background: PubMed 27835764Lindsay EK, Creswell JD. Mechanisms of mindfulness training: Monitor and Acceptance Theory (MAT). Clin Psychol Rev. 2017 Feb;51:48-59. doi: 10.1016/j.cpr.2016.10.011. Epub 2016 Nov 5.
- Background: PubMed 26992885Li G, Yuan H, Zhang W. The Effects of Mindfulness-Based Stress Reduction for Family Caregivers: Systematic Review. Arch Psychiatr Nurs. 2016 Apr;30(2):292-9. doi: 10.1016/j.apnu.2015.08.014. Epub 2015 Aug 28.
- Background: PubMed 17548782Steadman PL, Tremont G, Davis JD. Premorbid relationship satisfaction and caregiver burden in dementia caregivers. J Geriatr Psychiatry Neurol. 2007 Jun;20(2):115-9. doi: 10.1177/0891988706298624.
- Background: PubMed 31031678Campos D, Modrego-Alarcon M, Lopez-Del-Hoyo Y, Gonzalez-Panzano M, Van Gordon W, Shonin E, Navarro-Gil M, Garcia-Campayo J. Exploring the Role of Meditation and Dispositional Mindfulness on Social Cognition Domains: A Controlled Study. Front Psychol. 2019 Apr 11;10:809. doi: 10.3389/fpsyg.2019.00809. eCollection 2019.
- Background: PubMed 30100929Luberto 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.
- Individual participant dataSharing planned: No
Related trials for Mindfulness Based Stress Reduction
Not yet recruiting
MBSR Effects on Aging Anxiety and Body Image
Body Image, Mindfulness Based Stress Reduction
Active, not recruiting
Mindfulness-Based Intervention With a Supplement for Stress-Related Problems in College Students Across Multiple Sites (4SITE)
Stress, Mental Health
Recruiting
Effect of Mindfulness-Based Stress Reduction on Birth Memory and Perception of Traumatic Birth
Postpartum Psychological Stress, Mindfulness-Based Stress Reduction
Active, not recruiting
The Effect of a Mindfulness-Based Stress Reduction Program on Feelings of Being a Geriatric Burden in Older Women
Effects of Mindfulness-Based Stress Reduction on Feelings of Geriatric Burden Among Older Women
Not yet recruiting
Effect of Mindfulness-based Psychoeducation in Depression
Depression - Major Depressive Disorder, Mindfulness Based Stress Reduction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine P Rankin, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction and Self-Guided Mindfulness eCourse in people with Mindfulness Based Stress Reduction and Caregiver Burnout, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) Score (time frame: Baseline, 21 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04977245, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.