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Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia

Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03857308
Acronym
CARING
Enrollment
9
Registered
2019-02-27
Start date
2019-11-13
Completion date
2020-03-25
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers, Burnout, Sleep

Keywords

well-being, sleep, caregiver

Brief summary

This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.

Detailed description

The research project will be conducted over approximately 9 months and will consist of three data collection sessions for each participant. The three data sessions will occur before, after, and at 3-month follow-up of an 14-day, online stress-reduction training, in which participants will be asked to complete about 25 to 30 minutes of practice each day in one of two stress-reduction techniques. Participants will be randomly assigned to either a mindfulness training program or a reappraisal training program. The mindfulness training emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas the reappraisal training emphasizes cognitive strategies to change one's perception of the stressor as a way to reduce stress and promote well-being.

Interventions

BEHAVIORALMindfulness Training

This stress reduction training will last 14 days and teach participants skills in concentration, monitoring of present-moment bodily experience, and acceptance of experience. Participants are encouraged to mentally welcome all physical and emotional experience. Each day will consist of approximately 25 to 30 minutes of training. A full explanation of the mindfulness training compared to the reappraisal training could interfere with study blinding procedures. A complete description can be provided after data collection is complete.

This stress reduction training will last 14-days. Each day consists of 25 to 30 minutes of daily practice in Coping control. Participants are encouraged to reframe and reappraise life events, both past and present, and encouraged to solve personal problems through active change. A full explanation of the reappraisal stress reduction program compared to the mindfulness program could interfere with study blinding procedures. A complete description can be provided after data collection is complete.

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* English speaking * Self-reporting informal caregivers of persons with dementia

Exclusion criteria

* Self-reported major depressive disorder with psychotic features * History of schizophrenia * Bipolar disorder * Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions * Previous MBSR training or regular meditative practice within previous 6 months

Design outcomes

Primary

MeasureTime frameDescription
Change in Eudaimonic well-beingBaseline to 2-weeks (post-intervention), and 3-month follow-up54 item self-reported scale assessing change in eudaimonic well-being from pre to post-intervention. Will be assessed using the Scales of Psychologica Well-being (SPWB; Ryff & Keyes, 1995) 1 = strongly disagree, 6 = strongly agree. This scale range applies for the 6 subscales, which can stand-alone, or be summed to obtain a total Eudaimonic Well-Being score. For this study, we are primarily interested in investigated changes over time of the summed score for eudaimonic well-being. Higher scores indicate higher eudaimonic well-being.
Change in Sleep QualityBaseline to 2-weeks (post-intervention), and 3-month follow-upWe will use a sleep diary that involves self-reported sleep habits, which we will use to calculate sleep onset, wake after sleep onset, and sleep efficiency. This will allow us to understand any changes in overall sleep quality across the intervention.
Change in Sleep Quality: ActigraphBaseline to 2-weeks (post-intervention), and 3-month follow-upActigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.

Secondary

MeasureTime frameDescription
Change in Relationship QualityBaseline to 2-weeks (post-intervention), and 3-month follow-upThe Mutuality Scale of Family Care Inventory (Archbold, Stewart, Greenlick, & Harvath, 1990) will be used to assess for change in caregiver/care recipient relationship quality. It is a 15-item self-report measure to assess caregiver's perceived relationship quality with the care recipient. The scale items range in score from 1 to 4, with higher scores indicating greater relationship quality. Items are summed to create a total score.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026