Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers

NCT ID: NCT04058886

Last Updated: 2023-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2022-07-06

Brief Summary

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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

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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.

Conditions

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Alzheimer Dementia Caregiver Dementia Alzheimers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Telephone-delivered Mindfulness

Participating caregivers and care partners will receive mindfulness training in 8 weekly telephone sessions plus one retreat. Respite care for the care recipient is provided for the retreat.

Group Type EXPERIMENTAL

Telephone-delivered Mindfulness

Intervention Type BEHAVIORAL

The telephone-delivered mindfulness training intervention that will incorporate the following elements: 1) training for primary caregivers (CG) and their caregiving partner (CP) in a telephone-based mindfulness training intervention; 2) groups of up to eight participants (four CG-CP pairs) plus an instructor, on a shared telephone line; and 3) training in a 8-week, modified MBSR program, which places additional emphasis on training in the following: a) mindful experiencing, including mindfulness of feelings and body sensations; b) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and c) mindful compassion for self and others. Additionally, homework assignments will involve listening to exercises on a dial-in telephone line; and assignments for CG-CP dyads (e.g. mindful listening and communication practices) as well as CG mindfulness practices in the presence of care recipients (e.g. mindful eating, and mindful listening).

Interventions

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Telephone-delivered Mindfulness

The telephone-delivered mindfulness training intervention that will incorporate the following elements: 1) training for primary caregivers (CG) and their caregiving partner (CP) in a telephone-based mindfulness training intervention; 2) groups of up to eight participants (four CG-CP pairs) plus an instructor, on a shared telephone line; and 3) training in a 8-week, modified MBSR program, which places additional emphasis on training in the following: a) mindful experiencing, including mindfulness of feelings and body sensations; b) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and c) mindful compassion for self and others. Additionally, homework assignments will involve listening to exercises on a dial-in telephone line; and assignments for CG-CP dyads (e.g. mindful listening and communication practices) as well as CG mindfulness practices in the presence of care recipients (e.g. mindful eating, and mindful listening).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Gaylord, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Sharon Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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UNC Program on Integrative Medicine

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Faurot KR, Roth I, Harr E, Shafer J, Giscombe K, Sheffield-Abdullah KM, Lathren C, Brantley M, Williams SW, Gaylord SA. Feasibility of a Telephone-Delivered Mindfulness Intervention for Informal Caregivers of Rural-Dwelling African Americans With Dementia. Glob Adv Integr Med Health. 2025 Jun 4;14:27536130251347944. doi: 10.1177/27536130251347944. eCollection 2025 Jan-Dec.

Reference Type DERIVED
PMID: 40475373 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R21AG061728

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0053

Identifier Type: -

Identifier Source: org_study_id

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