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Mindfulness-Based Stress Reduction in Dementia Caregivers (MBSR)

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ClinicalTrials.gov Identifier: NCT04977245
Recruitment Status : Active, not recruiting
First Posted : July 26, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

Aims: The overall study will contribute to understanding how the cultivation of caregiver mindfulness might improve the quality of relationship between caregivers and demented patients by making it more mutual, connected, empathic and positive. This study will additionally elucidate which facets of mindfulness account for caregiver's happiness and psychological well-being. Lastly, investigators will explore whether the cultivation of mindfulness skills to caregivers will have an impact on dementia patients' lifestyles, investigating the idea that the fruits of mindfulness training can be leveraged by both the caregiver and the care-recipient.

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.


Condition or disease Intervention/treatment Phase
Mindfulness Based Stress Reduction Caregiver Burnout Caregiver Stress Syndrome Dementia Dementia Frontal Frontotemporal Dementia Frontotemporal Lobar Degeneration Other: Mindfulness-Based Stress Reduction Other: Self-Guided Mindfulness eCourse Not Applicable

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 relationship quality. 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 well-being of caregivers. 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. Investigators will further explore the impact of caregiver mindfulness cultivation on the care recipient's lifestyle manifested as frequency and pleasure the dementia patient receives from 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.)
Masking: None (Open Label)
Masking Description: Due to the nature of this study, masking is not possible. Participants and researchers must be aware of which arm they are in.
Primary Purpose: Supportive Care
Official Title: Mindfulness-Based Stress Reduction Intervention in Caregivers of Dementia Patients: A Randomized Clinical Trial
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022


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

Active Comparator: Self-Guided Meditation eCourse
Participants in the active control group will participate in a self-guided, online program named GARDEN. The self guided material teaches skills about increasing the daily experience of positive emotion as a mechanism to assist with stress coping. The program consists of eight skills introduced and discussed over an eight week period.
Other: Self-Guided Mindfulness eCourse
Six weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist




Primary Outcome Measures :
  1. Change in Depression Anxiety Stress Scales 21 (DASS-21) Depression Scale [ Time Frame: Baseline, 21 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Depression Anxiety Stress Scales 21 (DASS-21) Anxiety Scale [ Time Frame: Baseline, 21 weeks ]
    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.

  2. Change in Depression Anxiety Stress Scales 21 (DASS-21) Stress Scale [ Time Frame: Baseline, 21 weeks ]
    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.

  3. Change in Zarit Burden Interview (ZBI) Score [ Time Frame: Baseline, 21 weeks ]
    The Zarit Burden Interview (ZBI) assess the stresses experienced by caregivers of patients with dementia. It assesses 22 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 88; higher scores denoting more stresses experienced by caregivers.

  4. Change in Difficulties in Emotion Regulation Scale (DERS) Score [ Time Frame: Baseline, 21 weeks ]
    The DERS is a 36-item self-report questionnaire. DERS total score ranges from 36-180. Higher scores reflect higher difficulties in emotion regulation.

  5. Change in Pleasant Events Schedule (PES) Score [ Time Frame: Baseline, 21 weeks ]
    The Pleasant Events Schedule (PES) indicates the frequency of engagement in enjoyable events, and higher scores suggest greater enjoyment with events and activities. For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no). Higher scores indicate higher frequency and pleasantness of activities.

  6. Change in Five Facets Mindfulness Questionnaire (FFMQ) Score [ Time Frame: Baseline, 21 weeks ]
    The FFMQ is a 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).

  7. Change in Self Compassion Scale (SCS) Score [ Time Frame: Baseline, 21 weeks ]
    Self Compassion Scale (SCS) total score, a 26-item self-report measure of self-compassion. Scores range 12-60 with higher scores indicating greater self compassion.

  8. 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.

  9. Change in Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT) Score [ Time Frame: Baseline, 21 weeks ]
    The CompACT is a self-report measure of psychological flexibility. Total scores on the measure range from 0-138 with higher scores indicative of greater psychological flexibility.

  10. Change in Fears of Compassion Scale (FCS) Score [ Time Frame: Baseline, 21 weeks ]
    The FCS is measure of the fear of showing one's self compassion. Scores range from 10 to 50, with higher scores indicative of greater fears of self compassion.

  11. Change in Caregiver Self-Efficacy Score [ Time Frame: Baseline, 21 weeks ]
    A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy.

  12. Change in Scale of Positive and Negative Experiences (SPANE) PA Subscale Score [ Time Frame: Baseline, 21 weeks ]
    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).

  13. Change in Hedonic and Eudaimonic Motives for Activities (HEMA) Scale [ Time Frame: Baseline, 21 weeks ]
    The HEMA scale assesses 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.

  14. 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 11 statements about positive aspects of caregiving on a 5-point Likert scale from "disagree a lot" to "agree a lot." Scores can range from 11 to 55 with higher scores indicating more subjective positive aspects of providing care to someone.

  15. Change in WHO Quality of Life BREF (WHOQOL BREF) Score [ Time Frame: Baseline, 21 weeks ]
    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.

  16. Change in The Awareness of Social Inference Task SIM (TASIT-SIM) [ Time Frame: Baseline, 21 weeks ]
    The TASIT is a test where participants 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.

  17. 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, defined as "the reactions of one individual to the observed experiences of another." It has 28 items using 5-point scales (A = does not describe me well to E = describes me very well). It has 4 sub-scales: fantasy which assesses the extent to which individuals identify with fictional characters; perspective-taking which assesses the extent to which individuals spontaneously (try to) adopt others' points of view; empathetic concern which assesses the extent of individuals' "feelings of warmth, compassion, and concern for others."; and personal distress which assesses the extent of individuals "feelings of anxiety and discomfort" as a result of "another's negative experience." Each of the 4 sub-scales has 7 items and scores range from 28 to 140. Higher scores indicate a greater amount of empathy for others.

  18. 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, defined as "the reactions of one individual to the observed experiences of another." It has 28 items using 5-point scales (A = does not describe me well to E = describes me very well). It has 4 sub-scales: fantasy which assesses the extent to which individuals identify with fictional characters; perspective-taking which assesses the extent to which individuals spontaneously (try to) adopt others' points of view; empathetic concern which assesses the extent of individuals' "feelings of warmth, compassion, and concern for others."; and personal distress which assesses the extent of individuals "feelings of anxiety and discomfort" as a result of "another's negative experience." Each of the 4 sub-scales has 7 items and scores range from 28 to 140. Higher scores indicate a greater ability to take on the perspective of other persons in social contexts.

  19. Mutuality scale of the Family Care Inventory (FCS) [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977245


Locations
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United States, California
University of California San Francisco UCSF
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Katherine P Rankin, PhD University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04977245    
Other Study ID Numbers: 20-31240
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Lobar Degeneration
Caregiver Burden
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Stress, Psychological
Behavioral Symptoms
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations