Clinical trial NCT04058886: Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers
Official title: Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness Intervention for Rural, African American Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Dementia
Caregiver
Dementia Alzheimers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-08-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is assesses the feasibility and acceptability of telephone-delivered mindfulness training designed to alleviate caregiver burden for African-American rural caregivers of individuals with moderate to severe dementia, as defined by the caregiver. The study utilizes a single-group, uncontrolled design to test the feasibility and acceptability of the intervention for the target population.

Detailed description: Mindfulness interventions can decrease caregiver burden and improve coping skills, including decreased emotion-based coping, increased tolerance for uncertainty, improved psychological well-being and quality of life while potentially improving relationship quality and communication.

This study utilizes a single-group, uncontrolled design to assess the feasibility and acceptability of telephone-delivered mindfulness training designed to alleviate caregiver burden for African-American rural caregivers of individuals with moderate to severe dementia, as defined by the caregiver. The telephone-delivered mindfulness intervention will improve geographical access for rural caregivers and deem more flexible for a caregiver's schedule. The study's intervention consists of mindfulness training delivered by telephone once weekly for 8 weeks. The intervention also includes one retreat for which respite care will be provided, if needed. The intervention, based on, Kabat-Zinn's mindfulness-based stress reduction (MBSR), will emphasize the following: 1) mindful experiencing, including mindfulness of feelings and body sensations; 2) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and 3) mindful compassion for self and others.

Eligibility criteria: Inclusion Criteria:

* The candidate is at least 18 years old;
* The candidate self-identifies as Black or African American;
* The candidate provides at least 4 hours of care per day to the care recipient, who must have either a diagnosis of dementia OR have a score of at least 2 or higher on the Alzheimer's Disease Screening tool (AD-8) or a score of 8 or higher on the Functional Assessment Staging of Alzheimer's disease (FAST) scale (indicative of moderate - severe dementia);
* The candidate is able to identify and recruit an additional informal caregiver (care partner) to participate in the study. The care partner must consider themselves as part of the caregiving team that helps to make decisions about the care of the care recipient. The care partner may be a blood relative or close friend, but not a formal caregiver. The care partner need not live in the same geographic area.
* Both the candidate primary caregiver and care partner must have access to a telephone and express a willingness to participate in the pre- and post-participation assessments, the intervention calls, and the intervention retreat.

Exclusion Criteria:

* The candidate is too unwell to participate; e.g., with an active diagnosis of cancer or more than 3 hospitalizations in the past year;
* The primary caregiver is unable to identify and recruit a care partner willing to commit to the study requirements;
* The care recipient does not meet the criteria for dementia.

Primary outcomes:
measure: Number of Participants Attending at Least 6 Telephone Sessions
timeFrame: 8 weeks
measure: Percent of Dyads Who Endorse the Program
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in the Zarit Burden Interview Short Form (ZBI-12) Score
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in the Family Satisfaction Scale (FSS) Score
timeFrame: up to 8 weeks
measure: Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Prospective Subscale Score
timeFrame: up to 8 weeks
measure: Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Inhibitory Subscale Score
timeFrame: up to 8 weeks
measure: Change From Baseline on PROMIS Meaning and Purpose-Short Form 6a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS Emotional Distress-Anxiety-Short Form 4a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS Emotional Distress-Anger-Short Form 5a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS Global Physical Health
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Acceptance)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Refocusing)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Planning)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Reappraisal)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Putting Into Perspective)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Rumination)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Catastrophizing)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Self-Blame)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Other-Blame)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS Emotional Support-Short Form 4a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS Informational Support-Short Form 4a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS Instrumental Support-Short Form 4a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS General Self-Efficacy-Short Form 4a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in Mean NPI-Q Distress Scores
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on PROMIS Self-Efficacy for Managing Emotions-Short Form 4a
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in the Family Conflict Strategies for Care Subscale
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in the Family Conflict Scale Attitudes and Actions Toward the Patient Subscale
timeFrame: Baseline, 8 weeks
measure: Change From Baseline on Family Conflict Scale (FCS) Actions and Attitudes Toward the Caregiver Subscale
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Program on Integrative Medicine
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Susan Gaylord, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill
name: Sharon Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: