Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia (CARING)
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|ClinicalTrials.gov Identifier: NCT03857308|
Recruitment Status : Terminated (Unable to continue enrollment for dissertation study due to COVID-19)
First Posted : February 27, 2019
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Caregivers Burnout Sleep||Behavioral: Mindfulness Training Behavioral: Reappraisal Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia|
|Actual Study Start Date :||November 13, 2019|
|Actual Primary Completion Date :||March 25, 2020|
|Actual Study Completion Date :||March 25, 2020|
|Experimental: Mindfulness Training||
Behavioral: Mindfulness 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.
|Active Comparator: Reappraisal Training||
Behavioral: Reappraisal Training
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.
Other Name: My Time
- Change in Eudaimonic well-being [ Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up ]
54 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 Quality [ Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up ]We 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: Actigraph [ Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up ]Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.
- Change in Relationship Quality [ Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up ]The 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.
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): NCT03857308
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Joseph Dzierzewski, PhD||Virginia Commonwealth University|